MAUDE Adverse Event Report: MICROVENTION, INC. VIA-17 MICROCATHETER; PERCUTANEOUS CATHETER

Model Number	VIA-17-154-45-MVI2
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Ruptured Aneurysm (4436)
Date of Event	07/30/2021
Type of Reportable Event	Death
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 not returned to the manufacturer for evaluation.Additionally, procedural images were not provided; therefore, the reported event cannot be confirmed.The instructions for use (ifu) identifies aneurysm rupture and death as potential complications associated with use of the device.
Event or Problem Description
It was reported that during treatment of an unruptured aneurysm of the anterior communicating artery, the physician was not satisfied with the position of a web device within the aneurysm.Therefore, in order to try a different sized web, the physician withdrew the original web into the microcatheter.Upon resheathing, the catheter apparently entered the dome of the aneurysm and ruptured it.The case was completed using embolization coils, but the patient passed away the following day.

• Brand Name: VIA-17 MICROCATHETER
• Common Device Name: PERCUTANEOUS CATHETER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 12376721
• Report Number: 2032493-2021-00351
• Device Sequence Number: 1180270
• Product Code: DQY
• UDI-Device Identifier: 00842429106440
• UDI-Public: (01)00842429106440(11)210409(17)240331(10)21040911J
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 07/30/2021

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: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: VIA-17-154-45-MVI2
• Device Catalogue Number: VIA-17-154-45
• Device Lot Number: 21040911J
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2021
• Initial Report FDA Received Date: 08/27/2021
• 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: Death
• Patient Age: 54 YR