MAUDE Adverse Event Report: MICROVENTION, INC. COSMOS 10 ADVANCED; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	8210-0522-A2
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A search for non-conformances associated with the reported part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was returned to the manufacturer for evaluation.The investigation is currently underway.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with use of the device.
Event or Problem Description
It was reported that during the treatment of an aneurysm, the embolization implant coil detached during positioning.A retrieval device was used to remove the implant coil.No further intervention or patient injury was reported.The patient was reported to be "in good condition.".
Additional Manufacturer Narrative
The coil was received with the pusher coils detached from the pusher.There was no damaged to the returned microcatheter.The investigation found pusher to be kinked near the transition, and the implant to be damaged and stretched.The monofilament profile for both coil and pusher indicated a non-thermal detachment.With the tail visible on the monofilament, this indicated a tensile break.The physical evaluation of the device could not identify the conditions or circumstances that led to the damage of the pusher and implant, but the damage is consistent with the device experiencing forces over specification.

• Brand Name: COSMOS 10 ADVANCED
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 11340975
• Report Number: 2032493-2021-00042
• Device Sequence Number: 3408935
• Product Code: HCG
• UDI-Device Identifier: 00816777021861
• UDI-Public: (01)00816777021861(11)200324(17)250228(10)2003245WC
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K082461
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2025
• Device Model Number: 8210-0522-A2
• Device Lot Number: 2003245WC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2021
• Initial Date Received by Manufacturer: 01/18/2021
• Supplement Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 02/17/2021
• Supplement Report FDA Received Date: 03/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention