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

Model Number	W5-4-2-MVI-3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Intracranial Hemorrhage (1891); Ruptured Aneurysm (4436)
Date of Event	03/02/2021
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 implanted in the patient and 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 perforation or rupture and hemorrhage as potential complications associated with use of the device.This device was used during the same procedure as the device referenced in mfr.Report # 2032493-2021-00098.
Event or Problem Description
It was reported that a subarachnoid hemorrhage (sah) due to an anterior communicating artery aneurysm was treated with a web device.The sah was not bleeding prior to treatment and the patient was stable.A via microcatheter was placed inside of the aneurysm and the web device was advanced up to the tip of the microcatheter.An angiographic run was performed and a rupture of the aneurysm was identified.The web device was deployed in the aneurysm and the rupture was controlled.It could not be determined which device caused the rupture.It was also not know if this was a perforation of the aneurysm or a re-bleed.The patient status is reported to be "ok.".

• 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: 11606754
• Report Number: 2032493-2021-00109
• Device Sequence Number: 11764565
• Product Code: OPR
• UDI-Device Identifier: 00842429110812
• UDI-Public: (01)00842429110812(11)210218(17)240131(10)21021812U
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 04/01/2021

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: 01/31/2024
• Device Model Number: W5-4-2-MVI-3
• Device Lot Number: 21021812U
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2021
• Initial Report FDA Received Date: 04/02/2021
• 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: Life Threatening; Required Intervention