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

Model Number	W5-5-2-MVI-3
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through the web pas clinical study that the web embolization device was in a procedure to treat a patient for anterior communicating artery complex aneurysm.A contrast injection after initial deployment showed complete occlusion of the aneurysm but with significant encroachment on the right a2 segment.The delivery wire was loaded so that more web braid would enter the aneurysm.A repeat contrast injection after this maneuver showed decreased encroachment onto the parent artery.The device was detached and the microcatheter was removed from the circulation.Post detachment angiogram showed no movement of the web device after detachment, with complete aneurysm occlusion but more encroachment onto the right a2 segment.In order to better delineate the degree of encroachment onto the right a2 segment, a different working projection was obtained using the 3d angiogram and again performed.This demonstrated that there was moderate (60%) encroachment onto the right a2 segment without flow restriction.Decision then made to terminate the procedure.No intervention performed or planned.The patient mrs remained at 1 at discharge on (b)(6) 2024 and at the 30-day follow-up visit on (b)(6) 2024.
Additional Manufacturer Narrative
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.Investigation conclusion: the physical device was not available for evaluation to investigate if a condition existed that would have contributed to event.Supplemental imaging was also unavailable for review; without imaging, the investigation cannot verify the event occurred as described, nor could the investigation further examine the cause of the reported event.This information may be updated if additional information is provided at a later date.

• Brand Name: WEB SL
• Common Device Name: INTRASACCULAR FLOW DISRUPTION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; alsio viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 21724195
• Report Number: 2032493-2025-90026
• Device Sequence Number: 9419103
• Product Code: OPR
• UDI-Device Identifier: 00842429110812
• UDI-Public: (01)00842429110812(11)240215(17)270131(10)0000514349
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/28/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: W5-5-2-MVI-3
• Device Lot Number: 0000514349
• 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: 03/27/2025
• Initial Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2024
• 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: VIA 17 MICROCATHETER (MICROVENTION)
• Patient Sex: Unknown