MAUDE Adverse Event Report: MICROVENTION, INC. COSMOS 18 ADVANCED; EMBOLIZATION COIL

Model Number	8218-1243
Medical Device Problem Codes	Separation Failure (2547); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number was provided.A review of the approved device history records indicated the lot met all release criteria.A lot history trending review was performed and there were no similar complaints for this lot number.The pusher was returned for analysis.The implant coil was detached from the pusher and was not returned.The body coil contained damaged coils at the distal.The proximal of the pusher was undamaged and within specification.The strain relief was found to be unburnt and folded.The resistance on the device was tested and registered an overload reading.The unit was tested with the returned v-grip and was found to register a red light in the four 90 degree offset directions.It was observed that the distal solder joints of both the yellow and green lead wires were broken.The monofilament rebound length was 0.070" with a stretched tail profile at the tip.Based upon the investigation analysis and available information, the reported complaint is confirmed.The device initially failed to detach electrically as a result of the broken distal solder joints.The strain relief was observed to be unburnt and the stretched tail monofilament profile is indicative of a tensile break.
Event or Problem Description
It was reported that during an embolization treatment, the coil would not detach.During the removal attempt, the coil detached in the catheter.The coil was successfully pushed through the catheter into the aneurysm; however, a tail of the coil extended into the parent vessel.The tail was affixed to the vessel wall with a stent.There was no reported clinical sequelae as a result of the issue.

• Brand Name: COSMOS 18 ADVANCED
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 7928904
• Report Number: 2032493-2018-00208
• Device Sequence Number: 11211921
• Product Code: KRD
• UDI-Device Identifier: 00811425028780
• UDI-Public: (01)00811425028780(11)160304(17)210304(10)160304V7
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K102365
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/02/2018

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: Other
• Device Expiration Date: 07/31/2022
• Device Model Number: 8218-1243
• Device Catalogue Number: 8218-1243
• Device Lot Number: 160304V7
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/02/2018
• Initial Report FDA Received Date: 10/02/2018
• 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