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

Model Number	VFC152060-V
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	09/13/2018
Type of Reportable Event	Malfunction
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 device has not been returned to the manufacturer.The instructions for use (ifu) identifies premature of difficult coil detachment as potential complications associated with use of the device.
Event or Problem Description
It was reported that during advancement of an embolization coil into a large middle cerebral artery aneurysm, the coil detached in the microcatheter.Both segments of the coil were removed in their entirety together with the microcatheter as a single unit.There was no reported patient injury or intervention.
Additional Manufacturer Narrative
Initial report indicated that the device was returning for manufacturer analysis; however, the device has not been returned for investigation.A product analysis could not be performed.The root cause is unknown.
Additional Manufacturer Narrative
The implant was returned for analysis.Visual inspection of the implant found that it retained its shape and no stretching was observed.The implant contained a minor kink on the second loop from the distal.The distal ball was found to be in good condition.The proximal tie knot of the monofilament was intact.The monofilament tip was not visible at the edge of the marker band.The implant coil was stretched at the proximal portion and it was observed that the monofilament contained a stretched tail, which is indicative of a tensile break.Based upon the investigation analysis and available information, the reported complaint of a detachment is confirmed.The monofilament stretched tail profile is indicative of a tensile break.The root cause of the failure could not be determined, as stretching was not present on the implant which would typically indicate over specification forces, and the pusher was not returned for analysis.

• Brand Name: MICROPLEX VFC FILL COIL
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 8144664
• Report Number: 2032493-2018-00268
• Device Sequence Number: 13889631
• Product Code: HCG
• UDI-Device Identifier: 00810170016271
• UDI-Public: (01)00810170016271(11)161017(17)210930(10)16101720
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K111451
• 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,Followup
• Report Date (Section B): 11/16/2018

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: 09/30/2021
• Device Model Number: VFC152060-V
• Device Lot Number: 16101720
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/16/2018
• Supplement Date Received by Manufacturer: 11/16/2018; 11/16/2018
• Initial Report FDA Received Date: 12/07/2018
• Supplement Report FDA Received Date: 01/25/2019; 02/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 90