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

Model Number	W2-9-7-MVI-3
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	07/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during treatment of an acomm aneurysm with a web device, the web was protruding and cut off flow prior to the end of the procedure.The physician decided not to place an adjunctive device.The patient experienced stroke like symptoms (loss of movement in left arm and leg).
Additional Manufacturer Narrative
A search for non-conformance 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 not returned to the manufacturer for analysis.Medical imaging was not provided.The event could not be confirmed.The instructions for use (ifu) identifies device ischemic stroke, as potential complications associated with use of device.

• Brand Name: WEB SL
• Common Device Name: INTRASACCULAR FLOW DISRUPTION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer (Section G): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142472000
• MDR Report Key: 15132909
• Report Number: 2032493-2022-00296
• Device Sequence Number: 17547771
• Product Code: OPR
• UDI-Device Identifier: 00842429107225
• UDI-Public: (01)00842429107225(11)210401(17)260331(10)21040117C
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P170032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/02/2022

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: 03/31/2026
• Device Model Number: W2-9-7-MVI-3
• Device Catalogue Number: W2-9-7
• Device Lot Number: 21040117C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2022
• Initial Report FDA Received Date: 07/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown