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

Model Number	FGA15080-040
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Intracranial Hemorrhage (1891); Eye Pain (4467)
Date of Event	03/01/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
A search for non-conformances 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 was implanted in the patient and not returned to the manufacturer for analysis.Additionally, procedural images were not provided; therefore, the reported event cannot be confirmed.The instructions for use identifies death and hemorrhage as potential complications associated with use of the device.
Event or Problem Description
It was reported that a web device was implanted in a ruptured aneurysm of the left internal carotid artery bifurcation on (b)(6) 2020 with good occlusion of the aneurysm and stagnate flow in the sac.The patient was evaluated one month post-op and the aneurysm did not show up on mra.The aneurysm was determined to be occluded.At three months post-op, the patient developed eye pain.Imaging revealed the aneurysm had grown significantly, the aneurysm appeared to have significant filling in the neck and base of the aneurysm sac, and the web was compacted into the dome.The patient experienced acute symptoms was diagnosed with a large subdural hematoma and subarachnoid hemorrhage.The patient later passed away.

• 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: 11853150
• Report Number: 2032493-2021-00177
• Device Sequence Number: 4017350
• Product Code: OPR
• UDI-Device Identifier: 00856956005817
• UDI-Public: (01)00856956005817(11)200304(17)250228(10)20030411C
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K162524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 05/18/2021

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: 02/28/2025
• Device Model Number: FGA15080-040
• Device Catalogue Number: FGA15080-040
• Device Lot Number: 20030411C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 05/19/2021
• 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: 73 YR