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

Model Number	VFC101540-V
Medical Device Problem Codes	Detachment Of Device Component (1104); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/27/2016
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 been returned for evaluation.The investigation is currently underway.
Event or Problem Description
It was reported that resistance was encountered when the embolization coil was being advanced in the microcatheter.During the removal attempt, the coil unexpectedly detached in the microcatheter.Both segments of the coil were withdrawn together with the microcatheter, and removed in their entirety.There was no reported intervention or patient injury.The patient was reported to be stable.
Additional Manufacturer Narrative
The device was returned with the dispenser coil, introducer, and the pusher.The implant coil was returned separately.The implant appeared to have retained its shape, and had evidence of the marker band and distal ball.A few minor kinks were noted on the pusher along its length.The attachment tether monofilament demonstrated presence of a tail-like shape, which is indicative of a tensile break.The strain relief on the distal heater coil section was noted to be folded, with no presence of burn marks, which is indicative of a non-thermal detachment.Based upon the investigation findings and available information, the complaint of a broken coil could be confirmed; the pusher and coil were noted to be separated.The root cause could not be determined; however, the device exhibited evidence that it was subjected to forces that exceeded its strength specification, with no evidence of a thermal detachment.

• 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: 7054885
• Report Number: 2032493-2017-00301
• Device Sequence Number: 1471968
• Product Code: HCG
• UDI-Device Identifier: 00810170016257
• UDI-Public: (01)00810170016257(11)170814(17)220731(10)1708141RC
• 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
• Report Date (Section B): 10/27/2017

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: Physician
• Device Expiration Date: 07/31/2022
• Device Model Number: VFC101540-V
• Device Lot Number: 1708141RC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/27/2017
• Supplement Date Received by Manufacturer: 10/27/2017
• Initial Report FDA Received Date: 11/22/2017
• Supplement Report FDA Received Date: 01/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1