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

Model Number	W5-4.5-2-MVI-3
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to the manufacturer for evaluation.The investigation is ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.
Event or Problem Description
It was reported that the web was positioned ideally, however would not detach.Several attempts were tried including opening a new detachment controller.This web was safely removed and a new device was implanted and detached on first attempt.It was attempted to detach this device on the back table after the case, and it still did not detach.The physician then manually pulled the device off of the pusher.The web and wire are all being returned.
Event or Problem Description
See h11.
Additional Manufacturer Narrative
The investigation of the returned web system found the implant separated from the pusher, which is consistent with the physician manually pulling the implant off the pusher as described in the reported event.The pusher was returned kinked at the hypotube-to-connector junction and the proximal connector was kinked at the brown lead wire joint.The heater coil pet and tether were found melted, indicating that the device was activated using a detachment controller during the procedure.Further inspection found the heater coil¿s forward and backward winds to be touching, resulting in the system to short, leading to the inability to detach as described in the reported event.The physical evaluation of the device could not identify the conditions or circumstances that led to the kinked pusher and proximal connector, but the damage is consistent with the device experiencing forces exceeding the delivery system's yield strength.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.Potential complications as referenced on the ifu, include but are not limited to the following: hematoma at the site of entry, aneurysm rupture, emboli, vessel perforation, parent artery occlusion, hemorrhage, ischemia, vasospasm, clot formation, device migration or misplacement, premature or difficult device detachment, non-detachment, incomplete aneurysm filling, revascularization, post-embolization syndrome, and neurological deficits including stroke and death.

• 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: 22755298
• Report Number: 2032493-2025-90386
• Device Sequence Number: 9364330
• Product Code: OPR
• UDI-Device Identifier: 00842429110799
• UDI-Public: 00842429110799
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 09/25/2025

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: 09/30/2025
• Device Model Number: W5-4.5-2-MVI-3
• Device Catalogue Number: W5-4.5-2
• Device Lot Number: 0000268244
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2025
• 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: 07/21/2025
• Supplement Date Received by Manufacturer: 09/03/2025
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 09/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2022
• 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: UNKNOWN CATHETER
• Patient Sex: Male