MAUDE Adverse Event Report: MICROVENTION, INC. WEB SL; INTRASACCULAR FLOW DISRUPTION DEVICE

Model Number	W5-6-4-MVI-3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Intracranial Hemorrhage (1891); Ischemia Stroke (4418)
Date of Event	09/12/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
A search for non-conformance's associated with the reported part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device remains implanted and not available for return to the manufacturer for analysis.Provided fluoroscopic image shows what appears to a web device implanted in an mca aneurysm.This image appears to have been taken immediately after implantation of the web device and does not contain content to confirm the complaint.The instructions for use (ifu) identifies ischemic stroke, hemorrhage and death as potential complications associated with use of the device.
Event or Problem Description
It was reported that a web device was used for treating a ruptured mca wide neck aneurysm.The case went very well and physician was able to place the web successfully on the first attempt.Dyna ct showed good wall apposition and all branches open.Final angiography showed some stagnation in the aneurysm, all vessels open and filling well.Patient woke up ok and went to the icu to recover.Reportedly, 45 minutes later the patient was showing signs of a stroke and ct showed a large hemorrhagic bleed.An open craniotomy was performed to evacuate the blood and a ventriculostomy placed.The next morning a repeat angiogram showed the aneurysm was occluded and the patient went back to the icu.Reportedly, the patient passed away a day or two later.

• Brand Name: WEB SL
• Common Device Name: INTRASACCULAR FLOW DISRUPTION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 12609584
• Report Number: 2032493-2021-00404
• Device Sequence Number: 1428602
• Product Code: OPR
• UDI-Device Identifier: 00842429110898
• UDI-Public: (01)00842429110898(11)210301(17)240229(10)21030116R
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: P170032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 09/12/2021

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: 02/29/2024
• Device Model Number: W5-6-4-MVI-3
• Device Catalogue Number: W5-6-4
• Device Lot Number: 21030116R
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2021
• Initial Report FDA Received Date: 10/11/2021
• 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