MAUDE Adverse Event Report: MICROVENTION, INC. V-TRAK; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	100204HS-V
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was implanted in the patient and not returned to the manufacturer for evaluation.Procedural or medical imaging was not provided.Without the return and physical evaluation of the device, the investigation is unable to determine if a condition existed that would have caused or contributed to the reported event.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.
Event or Problem Description
It was reported that during a procedure the coil did not release.A second controller of a different lot was used; however, the same failure was experienced.It was reported that standard technical recommendations were followed, including moistening the gold tip of the coil and rotating the controller to facilitate release.Despite these efforts, the audible release signal was not heard on any attempt, and the indicator light changed from green to orange without confirming deployment.It was reported that under fluoroscopic guidance, the coil was confirmed not to have released.The physician proceeded to remove the system, and through counter-traction, the coil detached while remaining within the microcatheter.The coil was then positioned within the aneurysm using advancement maneuvers with the pusher, where it was ultimately implanted.There was no patient injury.It is indicated that the patient was in good clinical condition.

• Brand Name: V-TRAK
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING 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: 24540365
• Report Number: 2032493-2026-00157
• Device Sequence Number: 9229535
• Product Code: KRD
• UDI-Device Identifier: 00816777020604
• UDI-Public: (01)00816777020604(11)251112(17)301031(10)0001452712
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K161452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/07/2026

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: 100204HS-V
• Device Lot Number: 0001452712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 03/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/12/2025
• 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: V-GRIP DETACHMENT CONTROLLER, LOT 0000715221; V-GRIP DETACHMENT CONTROLLER, LOT 0000799351
• Patient Age: 59 YR
• Patient Sex: Female