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

Model Number	W5-6-3-MVI-3
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A search for non-conformances associated with the reported 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.The instructions for use (ifu) identifies difficult or delayed web detachment as potential complications associated with use of the device.
Event or Problem Description
It was reported that two web devices were used during an aneurysm embolization case.The web was unable to detach from the delivery pusher with the use of multiple detachment devices.The web was withdrawn and removed from the patient.A second web device was placed and was unable to detach.Upon removal and retraction of the web, the device detached within the microcatheter.The web and microcatheter were removed from the patient and the case was completed with a third web device.There was no reported patient injury or intervention.This second web was used during the same procedure as the device reported in manufacture report number 2032493-2025-00252.
Event or Problem Description
No additional information received, please see h6 & h11.
Additional Manufacturer Narrative
Investigation conclusion: the investigation of the returned web system found the web implant to be separated from the pusher.The implant tether was found melted, which is an indication that the device was activated using a detachment controller.However, the pusher was not returned for evaluation.Since the pusher was not returned, the investigation could not perform electrical testing to determine if a condition existed on the pusher that would have caused or contributed to the alleged detachment issue and therefore, this complaint is considered non-verifiable.This web was used during the same procedure as the device reported in manufacture report number 2032493-2025-00252.

• 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: 21684864
• Report Number: 2032493-2025-00253
• Device Sequence Number: 8820109
• Product Code: OPR
• UDI-Device Identifier: 00842429110881
• UDI-Public: (01)00842429110881(11)230605(17)260531(10)0000368228
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 05/02/2025

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: 05/31/2026
• Device Model Number: W5-6-3-MVI-3
• Device Lot Number: 0000368228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2025
• 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: 03/06/2025
• Supplement Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 05/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2023
• 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: CONTROLLER WDC-2, 0000507635.; CONTROLLER WDC-2, 0000507635.; VIA 17 MICROCATHETER, PART, LOT UNKN.
• Patient Age: 63 YR
• Patient Sex: Female