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	04/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received by the manufacturer for evaluation.The investigation is currently ongoing.
Event or Problem Description
It was reported that a web device did not detach after multiple detachment attempts.The physician tried a new detacher and that did not work either.After multiple attempts, a new device was opened and that one detached without problems.The aneurysm location was basilar apex.Patient is intact.There was no intervention.

• 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: 25247487
• Report Number: 2032493-2026-00328
• Device Sequence Number: 10623427
• Product Code: OPR
• UDI-Device Identifier: 00842429110850
• UDI-Public: (01)00842429110850(11)230728(17)260630(10)0000399279
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2026

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 Expiration Date: 06/30/2026
• Device Model Number: W5-5-3-MVI-3
• Device Catalogue Number: W5-5-3
• Device Lot Number: 0000399279
• Date Returned to Manufacturer: 05/08/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2026
• Supplement Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 05/21/2026
• Supplement Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2023
• 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
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 174 LB