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

Model Number	W5-6-2-MVI-3
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Vasoconstriction (2126)
Date of Event	09/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was implanted in the patient and is not available for return to the manufacturer.The investigation is ongoing.Upon completion of the investigation, a supplemental report will be submitted.
Event or Problem Description
It was reported that the patient came in originally with a subarachnoid hemorrhage from a ruptured sidewall aneurysm.The first web embolization device was deployed but removed for unspecified reason.A second smaller size web device was then used and deployed but wouldn't detach when attempted; however, the device detached during push and pull maneuvering.Follow-up imaging 10-14 days post procedure showed the web had partially migrated into the mca and the patient experienced vasospasm.No mitigation was done and the web was left partially protruding into the mca and the physician did not attempt to snare out the device as clot had already formed and for fear of emboli break off.Vessel anatomy was possibly a factor.The web remains implanted in the patient.Current patient status was not provided.
Additional Manufacturer Narrative
Additional information: h6, h11 (additional information and investigation conclusion).Additional information was received indicating the patient is being monitored.Investigation conclusion: the physical device was not available for evaluation to investigate if a condition existed that would have contributed to the reported 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.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.

• 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: 23375398
• Report Number: 2032493-2025-90599
• Device Sequence Number: 21050460
• Product Code: OPR
• UDI-Device Identifier: 00842429117996
• UDI-Public: (01)00842429117996(11)241114(17)271031(10)0000755512
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: P170032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 10/29/2025

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: W5-6-2-MVI-3
• Device Lot Number: 0000755512
• 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: 10/08/2025
• Supplement Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/14/2024
• 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: DETACHMENT CONTROLLER (MICROVENTION).; VIA-17 MICROCATHETER (MICROVENTION).; WEB EMBOLIZATION DEVICE (MICROVENTION).
• Patient Age: 38 YR
• Patient Sex: Female
• Patient Weight: 93 KG