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

Model Number	W5-6-2-MVI-3
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2025
Type of Reportable Event	Malfunction
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.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 upon taking the web out of the packaging and tubing, the back end of the device was observed to have a very slight bend.The back end of the device was tested in the detacher.After observing the steady green light on the detacher, physician proceeded with placing the web.After about 5 mins of placement and deployment, physician attempted to detach the web.He connected to the detacher to the back end of the device again and the light went red and beeped.Physician tried repetitively to get the detacher to work but it never worked.A 2nd detacher was used, and it would not work.Physician resheathed and removed the web and put another web in.As the 1st web was removed, it was observed a more drastic bend to the back end of the web device.Prep, deployment and detachment with the 2nd web was very easy going with no problems.
Additional Manufacturer Narrative
The investigation of the returned web system found the proximal connector kinked at the brown lead wire joint, which is consistent with the condition described in the reported event.A broken body wire was found on the proximal shoulder of the implant; however, this would not have contributed to non-detachment.The unit did not pass continuity and resistance testing.Further inspection of the pusher 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 connector and broken solder joint, but these conditions are consistent with the device experiencing forces that exceeded the pusher's yield and tensile strengths.The broken implant wire is consistent with the device experiencing forces that exceeded the implant's tensile strength.
Event or Problem Description
See h10.

• 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: 22351443
• Report Number: 2032493-2025-90285
• Device Sequence Number: 4901666
• Product Code: OPR
• UDI-Device Identifier: 00842429117996
• UDI-Public: (01)00842429117996(11)250207(17)280131(10)0000923363
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 07/23/2025

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: W5-6-2-MVI-3
• Device Lot Number: 0000923363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2025
• 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: 06/04/2025
• Supplement Date Received by Manufacturer: 07/03/2025
• Initial Report FDA Received Date: 06/27/2025
• Supplement Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/07/2025
• 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 Age: 79 YR
• Patient Sex: Female