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

Model Number	W5-5-2-MVI-3
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the web embolization device was used in a procedure to treat a ruptured middle cerebral artery (mca) aneurysm.After deployment the device would not detach when attempted with a detachment controller.The physician was able to re-sheath and remove the device.Another web device of the same size was used to successfully complete the procedure.The patient was stable.
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 reported available for return but has not yet been received.The investigation is ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.
Additional Manufacturer Narrative
Additional information: d10 (date device returned), h6, h11 (device evaluation).No additional event information has been received.Investigation conclusion: the investigation of the returned web system found the heater coil windings stretched.The heater coil pet was found melted, indicating that the device was activated using a detachment controller during the procedure; therefore, the damage to the heater coil windings likely occurred post-activation.The stretched heater coil windings are an indication that the tether could have been caught in between the coil windings and caused the heater coil to stretch when the delivery system was pulled/retracted during the procedure.

• 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 95656 ; 7142478000
• MDR Report Key: 21108178
• Report Number: 2032493-2025-00045
• Device Sequence Number: 20871436
• Product Code: OPR
• UDI-Device Identifier: 00842429110843
• UDI-Public: (01)00842429110843(11)230926(17)260831(10)0000427379
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 02/14/2025

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: 08/31/2026
• Device Model Number: W5-5-2-MVI-3
• Device Lot Number: 0000427379
• 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: 12/23/2024
• Supplement Date Received by Manufacturer: 01/30/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 02/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2023
• 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: DETACHMENT CONTROLLER (MICROVENTION).; VIA 17 MICROCATHETER (MICROVENTION).
• Patient Sex: Unknown