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

Model Number	W2-8-3-MVI-3
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was stated to be available for return to the manufacturer for evaluation, but has not yet been returned despite attempts made.Additional due diligence attempts are ongoing.The alleged product issue/event as described could not be confirmed.If the device is received at a later date, an investigation will be performed and a supplemental mdr will be submitted.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.
Event or Problem Description
It was reported that web detachment was attempted with three detachers; however, it was unsuccessful.The web was removed and replaced with another web of the same size and the procedure was successfully completed.There was no patient injury.The patient was reported to be doing well.
Additional Manufacturer Narrative
The investigation of the returned web system found the pusher kinked at the hypotube-to-connector junction.The unit did not pass continuity and resistance testing.The heater coil did not show signs of activation using a detachment controller.Further investigation found the black lead wire broken at the distal solder joint, which is consistent with non-detachment.The physical evaluation of the device could not identify the conditions or circumstances that led to the kinked pusher, but the damage is consistent with the device experiencing forces exceeding the pusher's yield strength.The physical evaluation of the device could not identify the exact conditions or circumstances that led to the broken lead wire, but the damage is consistent with the device experiencing forces exceeding the solder joint's tensile strength.Batch review: 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.Complaint system review for the same batch: based on a review of the last 2 years of complaint data, and at the time of this investigation, no systemic issues have been identified for this batch number that would have caused or contributed to the reported event.Review of the device¿s risk documentation: a review of the risk analysis documents was performed and the hazards associated with this device issue have been addressed.
Event or Problem Description
See h11.

• Brand Name: WEB ANEURYSM EMBOLIZATION SYSTEM
• 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: 22835300
• Report Number: 2032493-2025-90418
• Device Sequence Number: 9934222
• Product Code: OPR
• UDI-Device Identifier: 00842429107140
• UDI-Public: (01)00842429107140(11)250711(17)300630(10)0001171399
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2025

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 Model Number: W2-8-3-MVI-3
• Device Lot Number: 0001171399
• 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: 08/15/2025
• Supplement Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 08/18/2025
• Supplement Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2025
• 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
• Patient Sex: Unknown