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

Model Number	W5-5-3-MVI-3
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the web sl implant was deployed in a basilar aneurysm with 90 take off from the neck, and it would not detach.They used a via-17 straight and had a bmx81 with a sofia5 fr 125 as intermediate support.They had to remove device and use a 2nd 5x3 device to complete the procedure, and it did detach.The patient had a good outcome.
Additional Manufacturer Narrative
The device was stated to be available for return to the manufacturer for evaluation but has not yet been returned despite attempts made.Additional due diligence attempts are ongoing.The alleged product issue/event as described could not be confirmed.If the device is received at a later date, an investigation will be performed and a supplemental mdr will be submitted.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.Potential complications as referenced on the ifu, include but are not limited to the following: hematoma at the site of entry, aneurysm rupture, emboli, vessel perforation, parent artery occlusion, hemorrhage, ischemia, vasospasm, clot formation, device migration or misplacement, premature or difficult device detachment, non-detachment, incomplete aneurysm filling, revascularization, post-embolization syndrome, and neurological deficits including stroke and death.

• Brand Name: WEB
• Common Device Name: INTRASACCULAR FLOW DISRUPTION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 24836806
• Report Number: 2032493-2026-00235
• Device Sequence Number: 16032502
• Product Code: OPR
• UDI-Device Identifier: 00842429110850
• UDI-Public: 00842429110850
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: W5-5-3-MVI-3
• Device Catalogue Number: W5-5-3
• Device Lot Number: 0000671344
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2026
• Supplement Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 04/09/2026
• Supplement Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/09/2024
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BMX81; SOFIA5 FR 125; VIA-17 STRAIGHT
• Patient Age: 68 YR
• Patient Sex: Female