Medical Device Alert dated 29 Dec 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/03/2022-DC (248) Date: 29th Dec 2022 MEDICAL DEVICE ALERT DEVICE MitraClip™ G4 Clip Delivery System and MitraClip™ NTR/XTR Clip Delivery System Description and Identification of the Incidence  The MitraClip Clip Delivery System is a heart valve repair device that is intended to treat mitral regurgitation. The increased rate of reports is for clips failing to “Establish Final Arm Angle” (EFAA) and for events of “Clip Opening While Locked” (COWL). o EFAA is a procedural step where the user intentionally attempts to open a locked Clip to verify that the locking mechanism is engaged. EFAA steps occur during device preparation and prior to Clip deployment. An EFAA failure occurs if the Clip opens during this verification step. o COWL describes when the Clip Arm angle increases post-deployment. In these cases, users observe a slippage in the lock, resulting in an Arm angle greater than 10 degrees from the angle observed at deployment. This change in arm angle after deployment can be identified through fluoroscopy  When the clip is locked, the locking mechanism is designed to more fully engage as the Grippers push down on the clip Arms. The constant force applied by the Grippers secures the leaflets within the clip. During a COWL event, the lock slips as the Clip Arms open by a given degree. In any case where significant residual MR is observed after Clip deployment, a second clip should be considered and implanted in accordance with the IFU Who May Be Affected  Any person with mitral regurgitation who has to be treated with the use of MitraClip™ G4 Clip Delivery System and MitraClip™ NTR/XTR Clip Delivery System Page 1 of 2 Health care providers who treat people with mitral regurgitation using the affected MitraClip™ G4 Clip Delivery System and MitraClip™ NTR/XTR Clip Delivery System Important Note: CDSCO have not received any complaints from the market on this issue. FURTHER DETAILS & CONTACTS M/s St. Jude Medical India Pvt. Ltd. had issued a Medical Device Safety Notice which is attached herewith this alert. M/s St. Jude Medical India Pvt. Ltd D.No.- 168/B/1, Plot 18 & 19, Laxmi Nager, Behind T B Hospital, MCH Circle-5, Mandal, Hyderabad, Telangana (India)-500038 www.sjm.com/India Email: indiaoffice@sjm.com Page 2 of 2URGENT MEDICAL DEVICE CORRECTION MitraClip Delivery System September 8, 2022 Commercial Name: MitraClip™ G4 Clip Delivery System, MitraClip™ NTR/XTR Clip Delivery System (reference Appendix A for model numbers) FSCA-Identifier: Clip Delivery System September 8, 2022 Manufacturer: Abbott Vascular Santa Clara, CA Type of Action: Advisory Regarding the Use of the Device Attention: Healthcare Professional, Implanting Physician Dear Valued Customer, Abbott is sharing information about the use of the MitraClip™ Delivery System. Abbott has observed an increase in complaints regarding Clip locking malfunctions. This communication is to bring awareness, share the actions Abbott is taking, and emphasize the relevant steps of the Instructions for Use (IFU) to aid in optimal function of the Clip locking mechanism. Your current inventory of product may be used with the guidance described in the attached materials. There is no need to return any product to Abbott. Description and Identification of the Incidence The increased rate of reports is for clips failing to “Establish Final Arm Angle” (EFAA) and for events of “Clip Opening While Locked” (COWL). • EFAA is a procedural step where the user intentionally attempts to open a locked Clip to verify that the locking mechanism is engaged. EFAA steps occur during device preparation and prior to Clip deployment. An EFAA failure occurs if the Clip opens during this verification step. • COWL describes when the Clip Arm angle increases post-deployment. In these cases, users observe a slippage in the lock, resulting in an Arm angle greater than 10 degrees from the angle observed at deployment. This change in arm angle after deployment can be identified through fluoroscopy (see example in Appendix A, Figure 1). Table 1 shows the estimated rate of EFAA Failure and COWL reports as function of MitraClip use. Table 1 Global Rate of MitraClip reported events over estimated clip usage Global Rate EFAA Failure Rate COWL Rate February 2021 – January 2022 0.51% 0.28% February 2022 - July 2022 0.80% 0.50% Potential Patient Risk Table 2 shows the outcomes and associated rates of EFAA failure and COWL events observed during MitraClip procedures. Table 2: Observed rates during a MitraClip™ procedure (February 2022 – July 2022) Patient Outcomes Observed EFAA failure Observed COWL 0.74% of total implants 0.30% of total implants No consequence to patient (91.7% of EFAA cases) (60.4% of COWL cases) 0.06% of total implants 0.19% of total implants Intraprocedural MR recurrence (7.7% of EFAA cases) (36.8% of COWL cases) 0.005% of total implants 0.01% of total implants Other1 (0.6% of EFAA cases) (2.8% of COWL cases) 1Depending on clinical status, treatments may include medical management, usage of an additional clip, catheter snaring technique or vascular surgery to remove embolized clip, or non-urgent surgical valve replacement/repair. Page 1 of 5URGENT MEDICAL DEVICE CORRECTION MitraClip Delivery System Appendix A: Example of imaging An example of a Clip opening by 17 degrees is shown in Figure 1. FLUOROSCOPIC CAD MODEL OVERLAYS Initial Arm Angle Opened Arm Angle 20° 37 ° (+17°) PRE-DEPLOYMENT POST-DEPLOYMENT PRE-DEPLOYMENT POST-DEPLOYMENT CLIP ARM ANGLE = 20° CLIP ARM ANGLE = 37° CLIP ARM ANGLE = 20° CLIP ARM ANGLE = 37° Figure 1: Fluoroscopic imaging of a Clip opening while locked (COWL) at deployment (left) with CAD model overlay super-imposed (right) Steps relevant to Clip lock mechanism The following information consist of the relevant steps of the Instructions for Use (IFU) and physician training materials with additional explanations to aid in optimal function of the Clip locking mechanism. 1. Unlocking the Clip During Device Preparation and Intraprocedural • Rotate the Lock Lever outward and then retract the lever until the mark on the lever is fully exposed. Rotate the Lock Lever inward to engage the lever. • Warning: DO NOT retract the lever forcefully. It may result in the inability to lock or unlock the Clip. • If Clip does not unlock and Clips Arms fail to open visibly, use the following techniques: Stop and return the Arm Positioner to Neutral. Retract the Lock Lever farther, then turn the Arm Positioner farther o in the “Close” direction before turning in the ‘Open’ direction. Advance the lock lever just enough so that the mark on the lever is still fully exposed. Turn the Arm Positioner to Neutral, then incrementally iterate the amount of Arm Positioner rotation in the “Close” o direction followed by rotation in the “Open” direction. Iterate until Clip opens or until it is no longer possible to rotate the Arm Positioner in the “Close” direction. Advance the lock lever just enough so that the mark on the lever is still fully exposed. Turn the Arm Positioner to Neutral, iterate the amount of Lock Lever retraction past the mark in 5 mm increments, o and rotate the Arm Positioner fully in the “Close” direction, before rotating in the “Open” direction, until Clip opens. Advance the lock lever just enough so that the mark on the lever is still fully exposed. Explanation: Forceful retraction of the Lock Lever involves retraction of the Lock Lever beyond the mark on the Lock Lever. This can inadvertently cause Harness deformation which can prevent the lock from functioning properly. 2. System Positioning • Initial Positioning in the Left Atrium: Position the Clip centrally over the valve with respect to anterior-posterior and medial- lateral directions. Align the Clip so the DC Shaft is perpendicular to the plane of the mitral valve. • Final system positioning: Raise the Grippers, Unlock the Clip and Open the Clip Arms to approximately 180 degrees. Adjust the system to reposition the Clip as necessary, rotate the DC handle to align the Clip Arms perpendicular to the line of coaptation. • Warning: Do confirm that the Clip Arms are perpendicular to the line of coaptation. Failure to do so may result in loss of leaflet capture and insertion. Explanation: If the Clip Arms are not perpendicular to the line of coaptation, or the Delivery Catheter (DC) is not perpendicular to the mitral valve plane during leaflet grasping, asymmetric tension on the leaflets may result in Clip rotation-post deployment and/or potential increase in MR. The Clip rotation could be interpreted as a change in Clip Arm angle. Page 3 of 5URGENT MEDICAL DEVICE CORRECTION MitraClip Delivery System 3. Locking Sequence (After Satisfactory Leaflet Grasp) • Close the Clip until the Clip Arm Angle is approximately 60 degrees. Release tension on the DC and secure the DC Fastener. • After verifying leaflet insertion and confirming the grasp is satisfactory, lock the Clip and slowly close the Clip just until the leaflets are coapted and MR is sufficiently reduced. Explanation: After leaflet capture and insertion confirmation, locking the Clip at Clip Arm angle >60 degrees is to ensure that there is enough room for the harness to center in a locked configuration. Adequate leaflet insertion is necessary to maintain the leaflets within the Clip. 4. Establish Final Arm Angle (EFAA) • With the Lock Lever fully advanced, and the Arm Positioner to Neutral (note the orientation of the blue line on the Arm Positioner), turn the Arm Positioner 1 turn in the “Open” direction (confirm blue line has returned to the original orientation). The Clip Arms may open slightly (~5°) and then remain in a stable position. • If continued opening of the Clip Arms is noted, reconfirm that the Lock Lever is completely advanced. Close the Clip Arms, and Establish Final Arm Angle. • Warning: DO NOT turn the Arm Positioner more than 1 turn in the “Open” direction from neutral. Failure to stop turning the Arm Positioner at 1 turn in the “Open” direction past neutral may result in Clip opening or device damage which could cause the Clip to become non-functional and lead to embolization and / or conversion to surgical intervention. • If Failure to Establish Final Arm Angle continues and the Clip lock does not hold, do not continue with deployment steps and replace the CDS. 5. Lock Line Removal • Pre-deployment Clip Assessment: Confirm DC Handle is secure, perform EFAA, turn the Arm Positioner to the “closed” side of the neutral position • Deployment step 1: Lock line removal: While holding the ends of the Lock Line remove the Lock Lever Cap and “O” ring. Unwrap the two ends of the Lock Line in a counterclockwise direction. Separate the ends of the Lock Line and remove the plastic cover from the lines so that no twists or knots are present. Grasp one of the free ends of the Lock Line, confirm the line moves freely, and slowly remove the Lock Line. Pull the Lock Line coaxial to the Lock Lever. If resistance is noted, stop and pull on the other free end to remove the Lock Line. • Perform EFAA. Explanation: When the Lock Line is removed, the locking mechanism may be disrupted and can cause the Clip Arms to open. Turning the Arm Positioner to the “close” side of neutral pulls the Clip Arms in the closed direction, which prevents the Clip Arm from opening during Lock Line removal. Therefore, post-Lock Line removal EFAA confirms the Clip did not unlock during Lock Line removal. Page 4 of 5URGENT MEDICAL DEVICE CORRECTION MitraClip Delivery System MitraClip™ G4 Clip Delivery System and MitraClip™ NTR/XTR Clip Delivery System Model Numbers All MitraClip lot numbers are within scope of this Correction Notice. Part Number Product Description GTN/UDI CDS0701-NT MitraClip G4 Clip Delivery System NT US 08717648230943 CDS0701-NTW MitraClip G4 Clip Delivery System NTW US 08717648230967 CDS0701-XT MitraClip G4 Clip Delivery System XT US 08717648230981 CDS0701-XTW MitraClip G4 Clip Delivery System XTW US 08717648231001 CDS0601-NTR MitraClip NTR Clip Delivery System US 08717648226342 CDS0601-XTR MitraClip XTR Clip Delivery System US 08717648226366 CDS0704-NT MitraClip G4 CDS NT REPAIR-MR Clinical 08717648234576 CDS0704-NTW MitraClip G4 CDS NTW REPAIR-MR Clinical 08717648234590 CDS0704-XT MitraClip G4 CDS XT REPAIR-MR Clinical 08717648234583 CDS0704-XTW MitraClip G4 CDS XTW REPAIR-MR Clinical 08717648234606 Page 5 of 5