ONYX Liquid Embolic System

## Medical Device Alert: Onyx Liquid Embolic System - Analysis Report **1. Executive Summary:** This report analyzes a Medical Device Alert issued by the Central Drugs Standard Control Organization (CDSCO) regarding the Onyx Liquid Embolic System (Onyx HD500). The alert addresses the risk of catheter entrapment associated with the use of Onyx, a liquid embolic agent used to block blood flow in arteriovenous malformations and hypervascular tumors. Key findings highlight the need for increased safety awareness among healthcare professionals and patients, emphasizing reporting of adverse events and providing additional safety information regarding catheter entrapment, its complications, and management. The alert also informs stakeholders about reported incidents globally and provides contact information for relevant manufacturers and the CDSCO. **2. Introduction:** This report provides an overview and analysis of the Medical Device Alert concerning the Onyx Liquid Embolic System, based solely on the information contained within the provided document. The purpose is to inform affected industries about the alert's key provisions, target audience, and potential impact. **3. Policy Overview:** This is a *Medical Device Alert*, rather than a new policy or formal policy amendment. * **Core Objective(s):** The primary objective is to communicate critical safety information to physicians, patients, distributors, and users regarding the risk of catheter entrapment associated with the use of Onyx. This includes raising awareness of potential complications, emphasizing the importance of adverse event reporting, and ensuring that users have access to additional safety information. **4. Background and Rationale:** Since this is a Medical Device Alert, the rationale focuses on emerging safety concerns. The alert addresses the issue of catheter entrapment during Onyx procedures. The text suggests that the increased reporting of incidents, including five deaths globally from 2005-2012, one death from July 2012 to February 2013, and 89 complaints in 2013, prompted the issuance of the alert. This suggests a need to reinforce awareness of the risks associated with this device. **5. Key Provisions / Changes:** The key provisions of this Medical Device Alert are as follows: * **Communication of Risk:** Direct communication to medical directors, healthcare professionals, distributors, users, and staff involved in patient management regarding the risk of catheter entrapment with Onyx. * **Information Update:** Specific changes to the "Information of Use" documentation to include additional safety information regarding catheter entrapment. * **Definition of Catheter Entrapment:** Defines catheter entrapment as the catheter becoming stuck in the implanted Onyx material. * **Complications Awareness:** Highlights the most serious complication being hemorrhage and death, with other complications including migration of the Onyx plug or catheter fragment. * **Management of Complications:** Acknowledges the potential need for antithrombotic drugs and imaging procedures (increasing radiation exposure) in patients with catheter entrapment. * **Adverse Event Reporting:** Encourages patients and healthcare professionals to report adverse events to the Manufacturer and CDSCO. * **Inventory Information:** Provides information on the number of Onyx units imported into India and the quantities held by distributors, sub-distributors, and hospitals. * **Contact Information:** Provides contact information for Micro Therapeutics, Inc. (dba ev3 Neurovascular), Covidien Healthcare India Pvt. Ltd., and the CDSCO. **6. Target Audience and Stakeholders:** The primary target audience includes: * Medical directors * Healthcare professionals (physicians, nurses, etc.) involved in using Onyx * Distributors and sub-distributors of Onyx * Users of Onyx (hospitals, clinics) * Patients undergoing procedures using Onyx **7. Implementation Aspects (Inferred):** * **Responsible agency/bodies:** The Central Drugs Standard Control Organization (CDSCO) is the issuing and overseeing body. Micro Therapeutics, Inc. (dba ev3 Neurovascular) and Covidien Healthcare India Pvt. Ltd. are responsible for disseminating the alert and addressing adverse event reports. Hospitals and distributors are responsible for informing their staff and users. * **Timelines or procedures:** The alert requests immediate action to inform stakeholders. No specific timelines are explicitly mentioned, however the information regarding inventory of the product in India suggests that the alert is to prevent further adverse events. * The text implies that updates to training materials and product information sheets are necessary. **8. Expected Outcomes / Impact of Changes:** The intended outcomes of this Medical Device Alert are likely to include: * Increased awareness among healthcare professionals and patients regarding the risk of catheter entrapment associated with Onyx. * Improved clinical decision-making regarding the use of Onyx. * More diligent monitoring of patients undergoing Onyx procedures. * Timely reporting of adverse events to the Manufacturer and CDSCO. * Potentially, a reduction in the incidence of catheter entrapment and associated complications. **9. Conclusion:** The CDSCO's Medical Device Alert regarding the Onyx Liquid Embolic System highlights significant safety concerns related to catheter entrapment. The alert is a critical communication to healthcare professionals, distributors, users, and patients, emphasizing the importance of awareness, reporting, and access to updated safety information. The document's significance lies in its potential to improve patient safety and minimize the risks associated with the use of Onyx in embolic procedures.

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