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

Model Number	W5-5-3-MVI-3
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2025
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.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.
Event or Problem Description
It was reported that the device was unable to detach from the pusher wire despite multiple attempts.The physician was able to resheath the device and use a different device.There was no patient injury/medical or surgical intervention performed.Patient outcome and condition were not affected by this device.
Additional Manufacturer Narrative
The reported complaint is confirmed.The investigation of the returned web system found the pusher bent at the proximal end of hypotube and at the hypotube-to-connector junction.The unit did not pass continuity and resistance testing.The pusher heater coil did not show signs of activation using a detachment controller.Further inspection found the brown 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 bent 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 non-conformance record was created for this batch number.The units with defects were rejected by quality check in process therefore no further containment was required.The remaining units from the lot met the release specification.The results of the complaint investigation did not reveal any potential or new manufacturing, design, quality, or other systemic issues, or non-conformances that would affect patient risk as defined in the risk management file.The complaint code and evaluation code are monitored through the trending process; corrective action is determined, as needed, through this process.No preventive, corrective or field safety corrective action is required.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 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: 22516436
• Report Number: 2032493-2025-90325
• Device Sequence Number: 8551077
• Product Code: OPR
• UDI-Device Identifier: 00842429110850
• UDI-Public: (01)00842429110850(11)241014(17)270930(10)0000722939
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2025

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: W5-5-3-MVI-3
• Device Lot Number: 0000722939
• 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: 06/25/2025
• Supplement Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 09/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2024
• 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: WEB DETACHMENT CONTROLLER.
• Patient Sex: Unknown