MAUDE Adverse Event Report: MICROVENTION, INC. VFC-AV; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	VFC061020-V-A2
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an aneurysm treatment procedure, one of the coils failed to detach using two detachment controllers.The user decided to remove the catheter to remove the coil.Reportedly, during removal, the coil unintentionally detached from the catheter.The catheter and coil were removed from the patient.The user then performed a test using both detachment controllers, but neither worked on this coil.The controllers worked on a coil from another batch, allowing the procedure to continue.There was no report of patient injury.
Additional Manufacturer Narrative
The device was returned to the manufacturer and the investigation is ongoing.Upon completion of the investigation, a supplemental mdr report will be submitted.
Additional Manufacturer Narrative
The investigation of the returned coil system found the pusher broken at the transition area, which is consistent with the alleged product issue.The distal portion of the pusher--with the implant still attached--was found stuck within the microcatheter.The physical evaluation of the device could not identify the conditions or circumstances that led to the broken pusher, but the damage is consistent with the device experiencing forces exceeding the pusher's tensile strength.The returned microcatheter was found to be in good condition and would not have caused or contributed to the reported complaint.A search for non-conformances 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.

• Brand Name: VFC-AV
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 24743018
• Report Number: 2032493-2026-00206
• Device Sequence Number: 9101213
• Product Code: HCG
• UDI-Device Identifier: 00816777022677
• UDI-Public: 00816777022677
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K132317
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2026

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: Health Professional
• Device Model Number: VFC061020-V-A2
• Device Lot Number: 0000381761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2026
• Supplement Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DETACHMENT CONTROLLER (X2) (MICROVENTION)
• Patient Sex: Unknown