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

Model Number	VFC061020-V-A2
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Thrombosis/Thrombus (4440); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2020
Type of Reportable Event	Serious Injury
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 device has not been received by the manufacturer for evaluation.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 a coil embolization procedure, the pusher coil was noted to have detached prior to thermal detachment of the implant coil with the controller.The coil remains implanted in the aneurysm.There was no reported patient injury.
Additional Manufacturer Narrative
Additional information clarified that treatment was performed for a posterior communication artery (pcom) aneurysm.After detachment, a coil tail extended into the parent artery, which was positioned in the external carotid artery, and thrombus was identified at the neck of the aneurysm.Integrilin and aspirin were administered.The device was received with the pusher coils separated from the pusher.There was no damaged to the returned microcatheter and introducer.The investigation found pusher to be kinked at the middle of the hypotube and proximal gold connector at e2.The physical evaluation of the device could not identify the conditions or circumstances that led to the damage of the pusher, but the damage is consistent with the device experiencing forces over specification.H11 - corrections- (b1)(b2)(h1) - additional information obtained via follow-up emails changes complaint from malfunction only to serious injury with intervention.(h6) - health effect - clinical code - add 4440.(h6) - health effect - clinical code - remove 4582.(h6) - health effect - impact code - add 4644.(h6) - medical device problem code - add 1157.

• 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: 11219873
• Report Number: 2032493-2021-00023
• Device Sequence Number: 3795330
• Product Code: HCG
• UDI-Device Identifier: 00816777022677
• UDI-Public: (01)00816777022677(11)200331(17)250228(10)2003315WV
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2021

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: 02/28/2025
• Device Model Number: VFC061020-V-A2
• Device Lot Number: 2003315WV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Initial Date Received by Manufacturer: 12/26/2020
• Supplement Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 01/23/2021
• Supplement Report FDA Received Date: 02/24/2021
• 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