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

Model Number	W5-4-2-MVI-3
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, web 4x2 was used in a w:3.2mm x h:2.7mm acomm aneurysm with tortuosity.Web device was positioned correctly and detachment was attempted.Controller was working with proper battery but no deflection.Attempt was made to advance via over proximal marker and device kept resheathing.Another attempt was made with wdc, then new wdc with same reference number.Another attempt was made to advance via but device did not detach and the device was resheathed and removed device.No patient injury or intervention was performed.
Additional Manufacturer Narrative
The investigation of the returned web system found the heater coil windings stretched.The device failed continuity and resistance testing, which is consistent with the stretched heater coil windings.However, the heater coil pet and implant tether were 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.The returned detachment controller was found to function as intended and would not have caused or contributed to the reported event.

• 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: 18862078
• Report Number: 2032493-2024-00200
• Device Sequence Number: 20892985
• Product Code: OPR
• UDI-Device Identifier: 00842429110812
• UDI-Public: (01)00842429110812(11)230725(17)260630(10)0000388654
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/07/2024

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: 06/30/2026
• Device Model Number: W5-4-2-MVI-3
• Device Lot Number: 0000388654
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2023
• 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: 02/21/2024
• Initial Report FDA Received Date: 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 74 YR
• Patient Sex: Female