MAUDE Adverse Event Report: MICROVENTION, INC. VIA-21 MICROCATHETER; PERCUTANEOUS CATHETER

Model Number	FGA21154-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ruptured Aneurysm (4436)
Date of Event	09/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.The device was discarded and not returned to the manufacturer for evaluation.Intraprocedural or post-procedural images were not provided for review; therefore, the reported event could not be confirmed.The instructions for use (ifu) identifies aneurysm rupture, vessel perforation, and hemorrhage as potential complications associated with use of the device.
Event or Problem Description
It was reported that treatment with a web device was attempted for an unruptured acom aneurysm.During the advancement of the implant through a via microcatheter, the aneurysm was perforated by the microcatheter before deployment of the implant.The system was removed, the procedure was successfully completed with balloon assisted coiling and evd.The patient had no neurological deficits and was reported to be stable, post-procedure.There was no reported malfunction of the via.

• Brand Name: VIA-21 MICROCATHETER
• Common Device Name: PERCUTANEOUS CATHETER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 10765376
• Report Number: 2032493-2020-00317
• Device Sequence Number: 3334247
• Product Code: DQY
• UDI-Device Identifier: 00851566003918
• UDI-Public: (01)00851566003918(11)190923(17)221031(10)19092326
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K150894
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/30/2020

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?: No
• Operator of Device: Other
• Device Expiration Date: 10/31/2022
• Device Model Number: FGA21154-01
• Device Catalogue Number: FGA21154-01
• Device Lot Number: 19092326
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 10/30/2020
• 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: Life Threatening; Required Intervention