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

Model Number	VFC061020-V
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	10/08/2018
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 treatment of a cerebral aneurysm, the coil did not detach.During withdrawal, the coil detached in the microcatheter.Both segments of the coil were removed in their entirety together with the microcatheter.There was no reported patient injury or intervention.The patient was reported to be in good health.
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 device was returned for analysis.The distal loop of the implant was slightly stretched and lost its shape.Several kinks and loss of shape were observed at the middle of the implant.The distal portion of the implant was undamaged.The proximal tie knot was in good condition.The monofilament was not visible in the bottom of the marker band.The implant was opened at the proximal tie knot and the monofilament was noted to be broken at the tie knot glue location.The monofilament break location is indicative of a detachment caused by a tensile break in the monofilament.A potential cause of the damage is over specification tensile forces being placed on the device.The report of non-detachment could not be confirmed, since 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: 8122746
• Report Number: 2032493-2018-00257
• Device Sequence Number: 251684
• Product Code: HCG
• UDI-Device Identifier: 00810170016226
• UDI-Public: (01)00810170016226(11)180413(17)230331(10)1804135V9
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 10/31/2018

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: 03/31/2023
• Device Model Number: VFC061020-V
• Device Lot Number: 1804135V9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2019
• Initial Date Received by Manufacturer: 10/31/2018
• Supplement Date Received by Manufacturer: 10/31/2018; 10/31/2018
• Initial Report FDA Received Date: 12/01/2018
• Supplement Report FDA Received Date: 01/25/2019; 04/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1