MAUDE Adverse Event Report: MICROVENTION, INC. VIA-33 MICROCATHETER; PERCUTANEOUS CATHETER

Model Number	FG33133-01
Health Effect - Clinical Code	Ruptured Aneurysm (4436)
Date of Event	12/29/2020
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 discarded at the user facility.Additionally, procedural images were not provided; therefore, the reported event cannot be confirmed.The instructions for use (ifu) identifies aneurysm rupture and neurological deficits including stroke and death as potential complications associated with use of the device.This device was used during the same procedure as the device referenced in mfr.Report # 2032493-2021-00050.
Event or Problem Description
It was reported that during the advancement of the web device through the via microcatheter to treat an acom aneurysm, the aneurysm ruptured, possibly due to movement of the microcatheter.The web device was immediately advanced into the aneurysm to repair the rupture and there were no additional intra-procedural events reported to manufacturer.The patient was reported to have died two days after the procedure.

• Brand Name: VIA-33 MICROCATHETER
• Common Device Name: PERCUTANEOUS CATHETER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 11336028
• Report Number: 2032493-2021-00048
• Device Sequence Number: 2671890
• Product Code: DQY
• UDI-Device Identifier: 00851566003703
• UDI-Public: (01)00851566003703(11)191028(17)220930(10)19102818
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/16/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: FG33133-01
• Device Catalogue Number: FG33133-01
• Device Lot Number: 19102818
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2021
• Initial Report FDA Received Date: 02/16/2021
• 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