Medical Device Alert date 21 June 2022

Central Drugs Standard Control Organization Directorate General of Health Services Ministry of Health and Family Welfare Government of India (Medical Devices and Diagnostics Division) Email: ddcimd-cdsco@nic.in Food & Drugs Administration Bhawan, Kotla Road, New Delhi. F.No. 29/Misc./03/2021-DC(276) Date: 21 June 2022 MEDICAL DEVICE ALERT PALMAZ GENESIS® Peripheral Stent on OPTA® PRO .035” Delivery System (PG2990PPX-82178943, PG2990PPX-82211305, PG3990PPS-82182764, PG3990PPX-82212989, PG3990PPX- 82218097) The Cordis PALMAZ GENESIS® Peripheral Stent on OPTA® PRO .035 Delivery System is intended for use in the treatment of atherosclerotic disease of peripheral arteries below the aortic arch. Cordis released Distributed Product Risk Assessment Form dated 18.05.2022 indicating increased complaint rate for stent dislodgement Cordis noted an increased trend in complaints for stent dislodgement and associated failure modes related to two specific sizes of the PALMAZ GENESIS® Stent on OPTA® PRO .035 Delivery System that were produced during a particular timeframe (October 2019 to April 2021). Identified through complaint trending analysis which consists of evaluating complaints based on key demographics used to identify potential commonalities. In this case there were manufacturing months with elevated complaint rates which upon further analysis identified the noted time period and product sizes to have an elevated rate when compared to the surrounding months. The potential impacts of stent dislodgement include an intra-procedural delay as the device is exchanged for another or may result in complications such as: unplanned percutaneous or surgical intervention, GI tract trauma or perforation. The recall is being undertaken due to stent dislodgement prior to or during placement and does not affect PALMAZ GENESIS stents that have been successfully deployed. To date, there have been no deaths or serious long Page 1 of 2term health sequelae, such as strokes, in the use of these involved complaint devices. e User interaction with the affected device/component: Balloon expandable stents are intended to be used as a scaffolding within a lesion or stricture to help maintain patency and improve the flow of blood and other body fluids. The Palmaz family of stents are intended for use in the peripheral vascular and the stent is delivered to the target on a balloon catheter called a stent delivery system. e Immediate and long Range Health Consequences: If movement of the Stent is detected before or during the procedure, the device can be exchanged resulting in an intra-procedural delay. If the stent is loose or inaccurately crimped on the balloon the stent may not be placed where intended in the target vessel. This may result in the need for additional stents to complete the procedure. In the event that none of these percutaneous methods are visible or successful the stent may be removed surgically. Therefore, the severity of the potential harm of a stent that dislodges from the stent delivery system is Critical. e Indirect Health Consequences: None Important Note: CDSCO have not received any complaints from the market on this issue. M/s Cordis Cashel, Ireland has released Distributed Product Risk Assessment Form dated 18.05.2022 which is attached herewith this alert. M/s Cardinal Health Medical Products India Pvt. Ltd., Bldg No. A3, Unit No. E, Babosa Ind Park, Mumbai Nashik Highway NH3, Saravali Village, Bhiwandi, Dist-Thane, Tal-Bhiwandi-14 (Thane Z5), Thane, Maharashtra (India)-421302 www.cardinalhealth.com Tel :022-42389278 Fax :022-42019191 Page 2 of 2Record Record (Non-PPE} 100603990 | Rev:1 Stent Dislodgement Released: 18 May 2022 CO: 100603985 Cordis Distributed Product Risk Assessment Form DPRA 100603990 Section 1: Background Product Name(s) and Marketing Status PALMAZ® GENESISTM on OPTATM Pro Catalog Number(s) US and Canada: PG2990BPS PG2990BPX PG3990BPS PG3990BPX Other Countries: PG2990PPS PG2990PPX PG3990PPS PG3990PPX Note: Each size consists of 4 catalog codes with the only difference being the delivery shaft length and the labeling for the 2 different markets. Lot Number(s) 82178943 82178944 82180267 82182764 82184215 82184806 82185924 82191321 82191527 82191727 82193089 82193097 82195965 82206059 82208524 82208532 82208537 82211296 82211305 82212821 82212989 82218097 82218087 82208528 Business Unit/ Site Legal Manufacturer External Manufacturer Cordis Cashel Confluent Medical Technology, Inc Cahir Road, Cashel Costa Rica, S.R.L., Co. Tipperary Coyol Free Zone, Building B25 Ireland El Coyol, Alajuela, Costa Rica Mus M Europe EU M Europe Non-EU [ Japan PM Asia Pacific M LatinAmerica Canada T Australia & High Severity Event Complaint rate exceeds threshold (significant trend) TTM Nonconformance potentially affecting distributed product [ Manufacturing or design confirmed Malfunction © Other: Description Of The Product Issue Under Review : Increased complaint rate for stent dislodgement Date this DPRA was initiated: 4/13/2022 Date issue was first discovered: 4/13/2022 Decision to initiate DPRA to determine risk How issue was first discovered: Increase in complaints for SDS Stent dislodgment F-11021 Rev 25, Distributed Product Risk Assessment Form Page lof 14 Only the native file to be used400603990 | Rev:1 Record Released: 18 May 2022 Record (Non-PPE} CO: 100603985 Stent Dislodgement Cordis. An increase in complaints of Palmaz Genesis stent dislodgment and associated failure modes was identified for the manufacturing time period of October 2019 thru April 2021. In March 2021, the issue was escalated by the Product Safety Clinician to the Cordis EM team and Confluent. An investigation by Confluent (COMP-00026) concluded that there was no evidence to show that the customer complaints were related to manufacturing deficiencies. In February 2022. the Product Safety Clinician escalated concerns of stent dislodgment to an action item via Monthly Complaint Review Meeting. In March 2022, Product Safety Clinician presented data that identified an increase in complaints for 2021. Additional review requested to be conducted by EM Manufacturing team. In April 2022, the decision was made to initiate a risk assessment to further capture the investigation, assess the risk to the patient and escalate accordingly. As part of that investigation, an assessment of the complaint data was pefromed to determine if any trends could be identified. A total of 105 complaints were identified for the time period Jan 2017 to Feb 2022 and further analyzed. 42 events implied a strong correlation between the failure and procedural/handling factors (force applied. off label use, etc.). Of the remaining 63 events Palmaz Genesis on Opta Pro (table below) was identified to have a rate above the expected occurrence per the SDS family risk management documents and was the driver of the identified increase in complaints. ie Lane Complaint prods | Rate% IPG _OPTA 0.07 IBLUE_AVIATOR [0.01 IBLUE_SLALOM _ 0.01 PG_AMIIA 0.00 IPG SLALOM _[0.00 [Total 0.04 The complaint data for PG on Opta Pro was further analyzed and revealed the start of the increase in complaint rates was for lots linked to a manufacturing timeperiod starting in October 2019 and continuing through to April 2021. orn 080 0.70 0.60 oso 0.40 0.30 0.20 0.10 eo P FF2 F2C 2 PFPETPS SSKFS KPDF SDM 2 As mamma Complaint Qty —===Complaint Rate wena bd v & The data was further refined to focus on products manufactured between Oct 2019 and Aprl 2021. The data F-11021 Rev 25, Distributed Product Risk Assessment Form Page 2of 14 Only the native file to be usedRecord Record (Non-PPE) Stent Dislodgement Cordis. revealed that the 2990 and 3990 product sizes were the main contributer to the increase in complaints Stent/Balloon Size Complaint Count Rate of total Distributed 2990 10 0.021 3990 8 0.017 2980 3 0.006 2590 1 0.002 2910 1 0.002 3910 3 0.006 2510 I 0.002 5980 1 0.002 2480 1 0.002 2960 1 0.002 2970 1 0.002 5990 1 0.002 Design or Manufacturing Factors Related to Issue Manufacturing Factors That May Contribute To Product Risk: The following manufacturing processes and failure modes have been identified in the pFMEA (owned by Confluent) as potential causes for stent dislodgement. As part of the investigation, these processes are being assessed to determine root cause. To date, all processes are operating as intended and product is conforming. The investigation is ongoing. Process name/ potential Failure Mode Potential Causes) Process Defect Incorrect mandrel Procedure not followed Incorrect mandrel Incorrect protective tube Operator Error Handling/ procedure not followed Incorrect protective tube Precmeine incortect time Operator Error Handling/ procedure not followed incorrect time Incorrect closing pressure Operator Error Handling/ procedure not followed Incorrect closing pressure Incorrect mandrel Operator Error Handling/ procedure not followed Incorrect mandrel Incorrect protective tube Operator Error Handling/ procedure not followed Incorrect protective tube Crimpeie Incorrect Time Operator Error Handling/ procedure not followed Incorrect Time Incorrect closing pressure Operator Error Handling/ procedure not followed Incorrect closing pressure fe Incorrect protective tube Operator Error Handling/ procedure not followed Incorrect protective tube esting Incorrect Die Incorrect set up/ setup procedure not followed _ Incorrect Die Incorrect Pressure Incorrect set up/ setup procedure not followed —_ Incorrect Pressure Plasma treatment Incorrect time Incorrect set up/ setup procedure not followed Incorrect time Incorrect potency Incorrect set up/ setup procedure not followed _ Incorrect potency Design Factors That Might Contribute To The Product Risk: No design factors have been identified to contribute to the product risk. Root Cause: Cordis has initiated a supplier corrective action, CA-MIA-02719 to investigate and determine corrective actions. This investigation consisted of a review of DHR’s, training records, scrap rates and nonconformances with a focus on the processes that secure the stent to the balloon of the catheter. Process walk-throughs have been conducted along with a review 100603990 | Rev:1 Released: 18 May 2022 CO: 100603985 of the stent retention testing used as an input for F-11021 Rev 25, Distributed Product Risk Assessment Form Page 3of 14 Only the native file to be used100603990 | Rev.1 Record Record (Non-PPE} Released: 18 May 2022 Stent Dislodgement CO: 100603985 Cordis lot release as well as any significant events that occurred around the start of the increase in complaint lots linked to a manufacturing month starting in October 2019 and returning to expected levels before April of 2021. It was noted that in April 2021. the following was done: 1) an awareness training was conducted to heighten operator awareness of the procedures related to stent crimping and nesting and 2) maintenance was performed on equipment related to stent crimping and nesting to evaluate equipment performance. This correlates with the end of the noted increase in the complaint lots per manufacturing month and aligns with the timeperiod in question of October 2019 to April of 2021. Investigations focused on the stent securing process has not identified a root cause thus far and the investigation is continuing via CA-MIA-02719. The process FMEA pFMEA-10069 Rev A was reviewed. All known potential causes have been captured. Reference Section 3 for review of harms and severities. oy aimed Pend] | Cool ‘ [D ee rte gc ati on | Parmaynay ea |b to Controls aap 2 + | [eve | owowme | 1 | tear NZ24P 2 4 6 Prew wood ' boassare can saan 2 1 0 [ere — | veo 1 reomer ie yeane 2 1 [we [rem [ween | 1 | hearectone rate 2 + | w [rec [veomms | 1 | hme 4321 2 1 % Pre we-09005- 1 loys ro vaare 2 1 a ee 1 teaect Tere vate 2 + |e [rvem [woe | 1 | net soare 1351P 2 1 PRPEW wa-o000s 1 Some sanaP z 1 prem — | wow : = vase 2 os ee ae waar 2 1 so | pre | ones 1 | tecorect Tare V44iP 2 ¥ w Pre we0000s- ' sacowract chert presre sa44P 2 1 Pe re « |e. 1521 2 1 we [pram | mono 1 | inmorect 1a11e aaa 8 panei and 2 o ry epg wa-noo10 ' | ee vezi | fiswra | comet @ | teovedsetun see 2 se el vest ae 2 Ce bd Ce Product Range Impact Total Number of devices in distribution: At the time of this assessment: Catalog Code_| Sum of Qty Distributed | Sum of Qty in Cordis Control PG2990BPS 282 3 PG2990BPX 207 0 PG2990PPS 191 0 PG2990PPX 368 42 PG3990BPS 406 0 PG3990BPX 203 28 PG3990PPS 514 0 PG3990PPX 323 23 Grand Total 2494 96 Number of devices subject to review: All quantities listed above are subject to this review F-11021 Rev 25, Distributed Product Risk Assessment Form Page 4of 14 Only the native file to be usedRecord 100603990 | Rev:1 Record (Non-PPE) Released: 18 May 2022 Stent Dislodgement CO: 100603985 Cordis Other Product Impact: No other product ranges in other marketed countries or product lines are Interim Product Containment Actions The impacted lots were identified by analyzing the complaint data. The catalog codes 2990 and 3990 for lots manufactured between Oct 2019 and April 2021 have an increased complaint rate. Two stop shipments were implemented ref EVENT-2022-04717 and EVENT-2022-04738. Production of these two product codes was also stopped until corrective/interim actions are implemented via sCAPA-MIA-02719. Internal Nonconformance Rate N/A This DPRA was triggered by complaints. TTM Occasional (5% to < 10%) I Remote (3% to < 5%) TF Improbable (< 3%) ¥ Not Applicable sCAPA-MIA-02719 EVENT-2022-04717 EVENT-2022-04738 aFMEA 100170787 Rev 4 100170784 aHL Rev. 4 F-11021 Rev 25, Distributed Product Risk Assessment Form Page Sof 14 Only the native file to be usedRecord 100603990 | Rev:1 Record (Non-PPE} Released: 18 May 2022 Stent Dislodgement CO: 100603985 Cordis Section 2: Compliance Evaluation (Completed by QA Dir r or designee) mpliance / Regulatory r Product distributed without required regulatory approval (e.g.. PMA, IDE, IND) or contrary to legal process (e.g., injunction, seizure, consent decree) T Confirmed or suspected counterfeit product, product tampering or sabotage I Entire lot does not meet label claims (e.g., identity, sterility, potency. stability) Violation of investigational product or clinical trial regulations: advertising and Rae promotional regulations; or product labeling regulations Required | I~ Confirmed or potential damage to environment, facility or equipment F Entire lot meets label claims, but does not meet product or process specifications Entire lot meets label claims and product/process specifications, but product TTM design may be deficient, or processes used to manufacture the lot may not meet GMP requirements T Other: Product does not meet label claims (e.g., identity, sterili y, potency. stability) - Isolated event or issue is not part of a systemic issue Product meets label claims, but does not meet product or process specifications - Isolated event or issue is not part of a systemic issue Product meets label claims and product/process specifications, but product design may RMB Decision | ¥ be deficient, or processes used to manufacture the product may not meet GMP by QA requirements Director or Designee co Product or lot meets label claims and product/process specifications, but the complaint or malfunction rate exceeds expectations Product or lot meets label claims and product/process specifications, and the complaint and malfunction rates are within expectations fF Other: M RMB review needed TTM RMB review not needed because: F-11021 Rev 25, Distributed Product Risk Assessment Form Page Gof 14 Only the native file to be usedRecord 100603990 | Rev:1 Record (Non-PPE) Released: 18 May 2022 Stent Dislodgement CO: 100603985 Cordis Product description and intended use: A PALMAZ stent placement is a procedure used to treat peripheral vascular conditions. There are a multitude of medical devices that are used or can be used to treat these conditions. For the current situation mentioned above, most of such products used in a catheterization procedure are affected. Such product families affected are PALMAZ Mounted Stents. Product descriptions and the indications for use can be found in each product lines respective instructions for use. Description of potential hazard(s) and harm(s), and any immediate and/or long range health Immediate and Long Range Health Consequences: If movement of the stent is detected before or during the procedure, the device can be exchanged resulting in an intra-procedural delay. If the stent is loose or inaccurately crimped on the balloon the stent may not be placed where intended in the target vessel. This may result in the need for additional stents to complete the procedure. It may also cause the stent to become dislodged from the stent delivery system in the body, away from the target lesion. If the stent remains on the guidewire it may be recaptured with a smaller balloon placed within the stent to withdraw it or deploy it where it is, or a buddy guidewire may be used to entangle with the stent wire and thus recapture it. However, if the stent is no longer on the guidewire it may be snared by using a snare device to lasso it. If that is not possible then the stent may be jailed against the wall of the vessel using another stent to prevent embolization of the stent to a smaller vessel or organ where it could obstruct flow. It is possible that embolization could result in peripheral ischemia. This may result in permanent impairment or damage to a body structure In the event that none of these percutaneous methods are viable or successful the stent may be removed surgically. Therefore, the severity of the potential harm of a stent that dislodges from the stent delivery system is Critical. Indirect Health Consequences: None The IFU (PALMAZ GENESIS® Peripheral Stent on OPTA® PRO .035" Delivery System 1539296 rev11) warns “Prior to stenting, the PALMAZ GENESIS® Peripheral Stent on OPTA® PRO .035" Delivery System should be examined to verify functionality and integrity. Do not attempt to remove or readjust the stent on the delivery system. Inspect the crimped stent for adherence to the balloon and centered placement in relation to the balloon marker bands. Do not reposition the stent or hand crimp.” If Device Failure Occurs Can It Be Recognized By The User: Offset, loosely crimped and/or dislodged stents can be recognized by the user. Segment of the Population Most at Ri F-11021 Rev 25, Distributed Product Risk Assessment Form Page 7of 14 Only the native file to be usedRecord Record (Non-PPE} Stent Dislodgement Cordi and competitor roducts are available on the market with the same indications for use. HN/A Number Of Complaints: The Cordis complaint database was queried for all complaints related to 29x90 and 39x90 Palmaz Genesis on Opta Pro for stent-dislodged. premature deployment, inaccurate placement and stent-offset/out of position manufactured between October 2019 and April 2019. 5 Complaint MFG Category Complaint # Create Date Event Country Catalog Lot Month fecry Patient Outcome No patient injury CASE-2020- UNITED STENT- 00119575-1 Jul-20 STATES PG2990BPX | 82185924 | Feb-20 DISLODGED eae No patient injury CASE-2020- STENT- ‘i 00119680-1 Jul-20 NETHERLANDS | PG3990PPS | 82178944 | Oct-19 | K1) GoGED — No patient injury CASE-2021- UNITED STENT- (unknown 00138854-1 fee STATES PG2S90BPX | 82185924 | Feb-20 | Hi OnGeD | where/when stent dislodged) CASE-2021 STENT- No patient injury paiasnce Jan-21 CHINA PG2990PPX | 82178943 | Oct-19 | OFFSET/OUT | (occurred during OF POSITION prep) CASE-2021- UNITED STENT- Expanded at oo1as7or-1 | Mer? STATES PE3990BPX | 82208524 | Dec-20 | pistopGeD | unintended location No patient injury CASE-2021- UNITED STENT- ‘i 00148677-1 Mar-21 STATES PG3990BPX | 82208524 | Dec-20 DISLODGED Ce CASE-2021- STENT- No patient injury Apr-21 CHINA PG2990PPX | 82191727 | Apr-20 LOOSE (occurred during 00149907-1 CRIMP. prep) CASE-2021- UNITED STENT- Expanded at 00152266-1 Ape STATES PG3990BPS | 82193089 | Jun-20 | oistopGeD | unintended location STENT- No patient injury cae May-21 a 100603990 | Rev:1 Released: 18 May 2022 CO: 100603985 ee PG2990BPS | 82184806 | Jan-20 | OFFSET/OUT | (removed with stent OF POSITION delivery system) STENT- DISLODGED; No patient injury CAE e028 May-21 UNITED PG2990BPX | 82185924 | Feb-20 STENT- (removed with stent 00153684-1 STATES . STRUT delivery system) UPLIFT CASE-2021- STENT- aa in sheath removed 00154015-1 May-21 CHINA PG2990PPX | 82191727 | Apr-20 DISLODGED with'sheath No patient injury CASE-2021- UNITED STENT- ‘ soiseio7d Jun-21 SATES PG2990BPS | 82208532 | Nov-20 | pie oncen iW CASE-2021- STENT- aa in sheath removed 00161752-1 Aug-21 CHINA PG2990PPX | 82191727 | Apr-20 DISLODGED with sheath No patient injury CASE-2021- UNITED STENT- 5 00165957-1 Sep-21 STATES PG2990BPS | 82184806 | Jan-20 DISLODGED a" No patient injury CASE-2021- STENT- 00167025-2 Oct-21 FRANCE PG3990PPS | 82208537 | Nov-20 DISLODGED foe as CASE-2021- UNITED STENT- No patient injury 00167416-2 Geuat STATES PGZQO0BES | Be2bese2 | Nov'20: | -pistopGeo (removed with F-11021 Rev 25, Distributed Product Risk Assessment Form Page 8of 14 Only the native file to be usedRecord 100603990 | Rev:1 Record (Non-PPE) Released: 18 May 2022 Stent Dislodgement CO: 100603985 Cordis. sheath) STENT- CRIMPING DIFFICULTY, STENT No patient injury SASES2022- Nov-21 jell PG2990BPX | 82208528 | Nov-20 | DIS STL EO ND TG-E D; (occurred during 00169983-1 STATES prep) and off-label PREMATURE | Oe had crammed pepLoymen | YS° imped) T, STENT- STRUT UPLIFT No patient injury CASE-2022- UNITED STENT- oor7eagaa | Feb-22 rares pessa0BPx | 82208524 | Dec-20 | no oncen local ne CASE-2022- Sent No patient injury poisavekr | (Feb22 BRAZIL pe2agorpx | 2211305 | Jan-21 | pcrorcen ll The overall rate for this subset is 19/2494 units distributed x 100 = 0.76%, Occasional. Hazard Occ rrence Rate Si N/A - Refer to Hazard Occurrence Rate for Cordis Santa Clara below Expected per FMEA Mounted SDS aFMEA Complaint Rate 100170787 Rev 4 DO Frequent (10% or >) TD Frequent (10% or >) TTM Probable (1% to < 10%) [ Probable (1% to < 10%) FTM Occasional (0.02% to < 1%) M Occasional (0.02% to < 1%) Remote (0.002% to < 0.02%) TM Remote (0.002% to < 0.02%) TTM Improbable (< 0.002%) [ Improbable (< 0.002%) T Not Applicable Expected per FMEA Complaint Rate F Very High > 1%) D Very High > 1%) TO High (0.5% to < 1%) E High (0.5% to < 1%) [7 Moderate (0.1% to < 0.5%) T Moderate (0.1% to < 0.5%) T Low (< 0.1%) D Low (< 0.1%) [7 Not Applicable F-11021 Rev 25, Distributed Product Risk Assessment Form Page Sof 14 Only the native file to be usedRecord 100603990 | Rev:1 Record (Non-PPE)} Released: 18 May 2022 Stent Dislodgement CO: 100603985 Cordis. Health Risk Assessment Using the following definitions list any reasonable and foreseeable Harm and determine the levels of severity and likelihood: Severity of Potential Harm SLS Life-threatening (death has or could occur) (Cordis Severity level: Critical [4] or Cordis Santa Clara Severity level: Critical [4]) SL4 Results in permanent impairment of body function or permanent damage to a body structure. (Cordis Severity level: Severe [3] or Santa Clara Severity level: Critical [4]) SL3 Necessitates medical or surgical treatment to preclude permanent injury. (Cordis Severity Level: Severe [3] or Santa Clara Severity level: Serious [3]) SL2 Temporary or reversible (a medical condition which would likely resolve itself and where medical treatment is optional).(Cordis Severity level: Moderate[2] or Cordis Santa Clara Severity level: Moderate [2]) SLI Limited (transient, minor impairment, no medical treatment required). (Cordis Severity level: Limited [1] or Cordis Santa Clara Severity level: Minor [1]) SLO No adverse health consequences (Cordis Severity level: Negligible [0] or Cordis Santa Clara, LikelihoSeovde roitfy H laevrelm: Minor [1]) L4 The product problem, when it exists, will always or almost always result in the identified harm. L3 The product problem has resulted, or can be reasonably expected to result, in the identified harm under normal circumstances at least some of the time. 12 The product problem has been known to result in the identified harm (documented or reported in clinical practice), but only occasionally and/or under unusual circumstances. Li The product problem has never been known to result in the identified harm, and it is not reasonable to expect that it ever would. Likelihood Likelihood Harm Severity (General (Population at Population) Greatest Risk) Intraprocedural Delay SLI L4 L4 Damage to Healthy Intima SL2 L3 L3 Additional Intervention SsL2 13 3 (percutaneous) Peripheral Vasospasm (peripheral) SL2 L3 L3. Indication Ischemia (peripheral) SL2 L2 L2 Perforation (peripheral) SL3 L2 L2 Additional Intervention (surgical) SL3 L3 L3 Dissection (peripheral) SL3 L2 L2 Thrombosis (peripheral) SL3 r2 L2 Additional | GI Tract Trauma SL 13 L3 harms r/t eee GI Tract Perforation SLS 12 12 ndication Applicable FMEA document and revision number: The Confluent process FMEA pFMEA-10069 Rev A was reviewed. However, the harms associated with the Biliary indication are not included. An update is required to add these to the pPMEA. A Change Task will be created in MyCordisPLM to track the required update to closure. F-11021 Rev 25, Distributed Product Risk Assessment Form Page lof 14 Only the native file to be usedRecord 100603990 | Rev:1 Record (Non-PPE} Released: 18 May 2022 Stent Dislodgement CO: 100603985 1244 Losartan & Pra 1224P ptrnoetoercetcitve 8 PPE Pre | tbe ‘ 1231P Creng a|e ad 8 PPEW 13s41P pInocsorererc t & ‘Operator Erkroir Handing! 2 PPE 4321P _ | Protective 8 Sesto eee 2 PREM eal Theoret Seog 1331P | and = 8 Selo 2 PPM 1344P cay | dTopseoinnegc t 8 Incorrectb ea tSetup’here 2 PPE Icorect Tnconen Sean? 1381P 8 saber shen 2 PREM incoree Eror tana @ | Spee Es Rann 2 ment sate aincorrect 2 | Specter Errrror Harting 2 Prem cree TU hncorect Emer 1431 Te | Spear aoe ence 2 PEW incoree a= 1441P. dosing a | Operator’ —- Apctarad 2 PPEM Incorrect Operator 1S11P (orm é E‘rnrootr Hfoalie ndiingy 2 PPE , ‘heared 1824P Incorrect ie 6 bechy fon 2 | PPeWw 1641 Iocoect 8 ‘Incorrecto at ae 2 8 | PhPeEe yP u | MESO tftnoorect 1621P Pas gel 8 incorrectD : ab steaed 2 6 6 tPesPt,E Wi /f Pub W-09010 t Incorrect time Incomect Incorrect set up setup PREW Put incorrect saaie @ = 2 e oo | PR | wcoo10 ' The Cordis Mounted SDS aFMEA 100170787 Rev 4 and Mounted SDS_ 100170784 aHL Rev. 4 were reviewed. Per CMO. necrosis would not occur. Additional assessment required (literature search) followed by review IFUs and Risk Management documents to remove necrosis. Change Tasks will be created in MyCordisPLM to track these items to closure. F-11021 Rev 25, Distributed Product Risk Assessment Form Page llof 14 Only the native file to be usedRecord 100603990 | Rev:1 Record (Non-PPE} Released: 18 May 2022 Stent Dislodgement CO: 100603985 Cordis. Lstot AFMEA Hazards General Risk |Ver tiCcoanttoronl Risk] 0 Step 102 | Proved eS! | 9g | Hazard Description | Hazadous | potentat Harm |S CPoateuntsiaet |, | Risk Level Meares _jOce ‘Stuaton(s) Vi Sameto f |fOa]° } bbeeftoerse |, Zonal | Measunes —_| ig) fRiisekr Level * | tation | eee fa 23 Stent la OF fia jICiauu ton: _Speaeni rus. [|iimFeU sa| [ALAP Should Parking |not rleuswisstuaante | fot liendt'eansd fe be fet a risk jt any leone fre la during reas either ure, lincure outa laccess of make Vemeval Is the lorthe juser bseivery aware lystem lor peor to licks Istent No on, te f4ur system tial lshould be fions | removes lcan be haken| i . 3 3 3 3 4 Applicable Hazard List: Hoa [Stent Oislodgement 1 7 7 wap «taza 1 1 ns13 2 1 534 2 7 623 2 7 Kes 2 1 raz 3 1 i723 3 1 732 3 7 243 3 7 3 r 7 7 F-11021 Rev 25, Distributed Product Risk Assessment Form Page 12of 14 Only the native file to be usedRecord 100603990 | Rev: Record (Non-PPE) Released: 18 May 2022 Stent Dislodgement CO: 100603985 Cordis Likelihood\ LI L3 L2 L4 Severity SLS TTM RMB required 7 RMB required I~ RMB required T~ RMB required RMB decision by Medical Director SL4 T or Designee T RMB required 7 RMB required F RMB required (requires review by QA Director) RMB decision by Medical Director SL3 1a) 9c Desens: M RMB required RMB required TTM RMB required (requires review by QA Director) RMB decision by RMB decision by Medical Director SL2 TTM RMB not required | ¥ Medical Director or Designee TTM RMB required or designee (requires review by QA Director) RMB decision by ps RMB decision by : A SLi IT RMB not required | 7 RMB not required FF Medical Director y resi Director or : lesignee or designee SLO [= RMB not required rr RMB not required TE RMB not required [ RMB not required RMB Recommendation By Medical Director or designee [ RMB not required (As per Escalation Recomendation table above) RMB review needed T RMB review not needed because: F-11021 Rey 25, Distributed Product Risk Assessment Form Page I3of 14 Only the native file to be usedRecord 100603990 | Rev:1 Record (Non-PPE} Released: 18 May 2022 Stent Dislodgement CO: 100603985 Cordis. Section 4: Decision Outcomes RMB Decision PM RMB required by Compliance evaluation in section 2 M RMB required by Health Risk Assessment Escalation in section 3 r RMB required if product does not meet label claims (section 2) and severity of the potential harm is SL2, SL3, SL4 or SL5 (Cordis Severity level 2-4). RMB required if product does not meet product or process specifications (section 2) and severity of the potential harm is SL2, SL3, SL4 or SL5 (Cordis Severity Level 2-4). T RMB not required, review by QA Director (section 3) T RMB not required (none of the conditions above met) N/A Issue escalated to RMB. The CAPA decision will be made by RMB and documented in the meeting minutes. Note: sCAPA-MIA-02719 has been issued to Confluent Medical Technologies. TTM CAPA needed - record CAPA number, if available: T CAPA not needed because: 1 CAPA decision deferred pending the following data: Risk Management or Labeling Updates N/A issue escalated to RMB. If updates to risk documents or labeling updates are required. the Miv decision will be made by RMB and documented in the meeting minutes. TF No Risk Document or Labeling updates needed because: fF Risk Documents or Labeling updates needed. List documents to be updated: Other Decisions or Comments N/A F-11021 Rev 25, Distributed Product Risk Assessment Form Page I4of 14 Only the native file to be used