MAUDE Adverse Event Report: MICROVENTION, INC. MICROPLEX VFC ADVANCED; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	VFC061020-V-A2
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A search for non-conformance associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The implant (i.E.Embolization coil) was not returned for evaluation; the investigation of the returned coil pusher found it to be severely stretched and entangled with a microcatheter.No evidence of activation using a detachment controller was found at the heater coil during the evaluation.Inspection of the monofilament found a non-mushroom profile, which is consistent with the implant separating due to tensile force.No notable conditions were found with the returned microcatheter.Due to the tangled state of the returned devices, it could not be determined when the stretching of the pusher occurred, but the stretching is consistent with the device experiencing forces over specification.Since the implant was not returned, it could not be determined if it had caused or contributed to the reported product issue.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with use of the device.
Event or Problem Description
It was reported that during coil embolization of a cavernous sinus fistula, the embolization coil unexpectedly detached.There was no reported patient injury or additional intervention.

• Brand Name: MICROPLEX VFC ADVANCED
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 10622849
• Report Number: 2032493-2020-00274
• Device Sequence Number: 16824331
• Product Code: HCG
• UDI-Device Identifier: 00816777022677
• UDI-Public: (01)00816777022677(11)191120(17)241031(10)1911205WV
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K111451
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/02/2020

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: 10/31/2024
• Device Model Number: VFC061020-V-A2
• Device Lot Number: 1911205WV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2020
• Initial Report FDA Received Date: 10/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR