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

Model Number	W5-4-2-MVI-3
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
T was reported that the web embolization device was used to treat a patient with an anterior communicating artery (acom) aneurysm.When the physician attempted to advance into the microcatheter, the 4x2 web device would not fit through the hub of the microcatheter.A second microcatheter was used without success.The physician then used a 4.5x2 web device, which advanced fine through the microcatheter; however, it was too large for the aneurysm and had to be removed.Since no other 4x2 web was available on the shelf, the procedure was re-scheduled for the next day and was successfully completed using a new 4x2 web device.The patient outcome described as "great.".
Additional Manufacturer Narrative
The device was reported available for return but has not yet been received.The investigation is ongoing.Upon completion of the investigation, a supplemental mdr report will be submitted.
Additional Manufacturer Narrative
Additional information: d10 (date device returned), h6, h11 (device evaluation conclusion).No additional clinical event information was received.Investigation conclusion: the investigation of the returned web system found the pusher hypotube kinked at the middle section and the web implant wires twisted at the proximal side.Furthermore, the device could not be advanced into the returned via microcatheter or an in-house via microcatheter due to the twisted implant wires during the investigation, which is consistent with the alleged product issue.The physical evaluation of the device could not identify the conditions or circumstances that led to the pusher kink and the twisted implant wires, but the damage is consistent with the device experiencing forces exceeding the pusher and implant's yield strength.The investigation did not find and any damage or other anomaly on the returned microcatheter that would have caused or contributed to the reported complaint.

• Brand Name: WEB SL
• 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: 22508923
• Report Number: 2032493-2025-90322
• Device Sequence Number: 9265404
• Product Code: OPR
• UDI-Device Identifier: 00842429110812
• UDI-Public: (01)00842429110812(11)241120(17)271031(10)0000775119
• Combination Product (Y/N): N
• 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): 08/21/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: W5-4-2-MVI-3
• Device Lot Number: 0000775119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 07/03/2025
• Supplement Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 4.5X2 WEB EMBOLIZATION DEVICE (MVI).; VIA MICROCATHETER (X2) (MICROVENTION).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown