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

Model Number W2-9-7-MVI-3

Device Problem Positioning Problem (3009)

Patient Problem Stroke/CVA (1770)

Event Date 07/02/2022

Event Type  Injury  

Event 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).

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
• Type of Device: 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
• MDR Text Key: 296906485
• Report Number: 2032493-2022-00296
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 00842429107225
• UDI-Public: (01)00842429107225(11)210401(17)260331(10)21040117C
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 07/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention