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

Model Number	W5-4-2
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	04/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: a1 aneurysm measured 2.85wx2.5h in ap view and 2.61wx2.90h in lat view.Successful web 4x2 deployment & detachment, then 9 hours afterwards, the web migrated from the left a1 aneurysm location to a2 vessel.It caused a stroke at that time and patient symptoms improved.Patient was brought back into angio lab, and doctor assessed that no intervention was best; no intervention was performed.Patient symptoms improved.Patient was in independent living.
Additional Manufacturer Narrative
As the lot number was not provided, a search for production-related non-conformances could not be performed.The device was implanted and therefore not available for return and investigation by the manufacturer.However, medical imaging was provided and will be reviewed.The investigation is ongoing and upon completion of the investigation, a supplemental mdr will be submitted.
Event or Problem Description
As reported: a1 aneurysm measured 2.85wx2.5h in ap view and 2.61wx2.90h in lat view.Successful web 4x2 deployment & detachment, then 9 hours afterwards, the web migrated from the left a1 aneurysm location to a2 vessel.It caused a stroke at that time and patient symptoms improved.Patient was brought back into angio lab, and doctor assessed that no intervention was best; no intervention was performed.Patient symptoms improved.Patient was in independent living.
Additional Manufacturer Narrative
Twenty radiographic images and one video were provided for review.They are not labeled as to date or time.The provided imaging shows a web device subtraction artifact superposed on the proximal upper division of the first a2 bifurcation; there is flow distal to the web.Throughout the provided images, the web remains in the same position; however, one image does show the web elongated in the proximal a3, which does indicate that web migrated as described in the reported event.Without the return and physical evaluation of the web device, the investigation cannot further examine if a condition existed that would have contributed to the reported event.

• 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: 21748451
• Report Number: 2032493-2025-90034
• Device Sequence Number: 9491984
• Product Code: OPR
• UDI-Device Identifier: 00842429110812
• UDI-Public: (01)00842429110812
• 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
• Device Implanted Year: 2024
• 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): 04/30/2025

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
• Was Device Available for Evaluation?: No
• 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: 03/12/2025
• Supplement Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Age: 50 YR
• Patient Sex: Male