MAUDE Adverse Event Report: MICROVENTION, INC. VFC ADVANCED FILL COIL; EMBOLIZATION COIL

Model Number	8310-0315
Medical Device Problem Codes	Detachment Of Device Component (1104); Difficult to Remove (1528)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/29/2017
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.The device has been returned to the manufacturer for evaluation.The investigation is currently underway.
Event or Problem Description
It was reported that while attempting to retract a coil from an aneurysm, the coil unexpectedly detached from the pusher.The pusher wire was removed and the detached coil was retrieved with a snare device.There was no reported patient injury.The current patient's status is reported to be good.
Additional Manufacturer Narrative
The device was returned within the microcatheter for evaluation.Upon removal, the implant was noted to be detached within the microcather.The marker band was present, as was the distal ball; the complete implant was returned.The distal end/heater coil section of the pusher was noted to be intact.The distal end of the monofilament in the pusher was examined.A tail was found, signifying a potential tensile break.Based on the investigation and provided information, the complaint of a detached implant can be confirmed.The specific root cause of this complaint is unknown, although the device exhibits evidence that it was subjected to tensile forces that exceeded its strength specifications.

• Brand Name: VFC ADVANCED FILL COIL
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 6525723
• Report Number: 2032493-2017-00107
• Device Sequence Number: 884859
• Product Code: HCG
• UDI-Device Identifier: 00811425028834
• UDI-Public: (01)00811425028834(11)150929(17)200929(10)150929VC1
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K132317
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2017

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: 09/29/2020
• Device Model Number: 8310-0315
• Device Catalogue Number: 8310-0315
• Device Lot Number: 150929VC1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/29/2017
• Supplement Date Received by Manufacturer: 03/29/2017
• Initial Report FDA Received Date: 04/27/2017
• Supplement Report FDA Received Date: 10/30/2017
• 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
• Patient Age: 80 YR