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

Model Number	8210-0837-A2
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A search for non-conformances associated with this 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 the embolization coil detached prematurely in the microcatheter.There was no reported patient injury or additional intervention.
Additional Manufacturer Narrative
The device was received with the implant separated from the pusher.No burn marks were found on the heater coil & distal black pet.Inspection on the implant found the coil loops deformed and stretched at the proximal tie knot section.The distal ball and attachment glue bonds were measured and were within specification.The monofilament was removed from the pusher body coil and displayed a stretched tail profile at the tip, indicating tensile forces were applied to the monofilament during the procedure.The device was received with the implant detached from the pusher.During the investigation on the device, the monofilament was removed from the pusher body coil and was found to have a stretched tail shape at the tip, indicating tensile forces were applied to the monofilament, which broke as a result.The conditions or circumstances that led to the damage could not be identified, but the damage is consistent with the device experiencing forces over specification.The microcatheter used in the procedure was not available for evaluation, so it could not be determined if it had caused or contributed to the reported complaint.

• Brand Name: COSMOS 10 ADVANCED
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo, ca
• MDR Report Key: 10274224
• Report Number: 2032493-2020-00162
• Device Sequence Number: 2246395
• Product Code: HCG
• UDI-Device Identifier: 00816777021922
• UDI-Public: (01)00816777021922(11)181121(17)231031(10)1811215WC
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K082461
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 10/31/2023
• Device Model Number: 8210-0837-A2
• Device Lot Number: 1811215WC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2020
• Initial Date Received by Manufacturer: 06/15/2020
• Supplement Date Received by Manufacturer: 07/14/2020
• Initial Report FDA Received Date: 07/14/2020
• Supplement Report FDA Received Date: 08/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1