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	09/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to the manufacturer for evaluation.The investigation is ongoing.Upon completion of the investigation, 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.The instructions for use (ifu) identifies web non-detachment as a potential complication associated¿with the use of the device.
Event or Problem Description
It was reported that there was normal vasculature in an aneurysm embolization for a basilar artery.No procedural complexity.Device deployment was attempted with the device appropriately positioned in the aneurysm.Via catheter was distanced appropriately.Upon use of the detacher, the device did not detach.Second attempt was made with detacher and red light showed.Second detacher was used with same result.Device did not detach.Attempt was made to detach using catheter abutment at base of web device.Device recaptured into the via.Device was successfully removed and new device was successfully deployed without incident.Good aneurysm occlusion and patient condition confirmed.The case was completed with placement of a new device of the same size.
Event or Problem Description
It was reported that there was normal vasculature in an aneurysm embolization for a basilar artery.No procedural complexity.Device deployment was attempted with the device appropriately positioned in the aneurysm.Via catheter was distanced appropriately.Upon use of the detacher, the device did not detach.Second attempt was made with detacher and red light showed.Second detacher was used with same result.Device did not detach.Attempt was made to detach using catheter abutment at base of web device.Device recaptured into the via.Device was successfully removed and new device was successfully deployed without incident.Good aneurysm occlusion and patient condition confirmed.The case was completed with placement of a new device of the same size.
Additional Manufacturer Narrative
Items returned for evaluation: -pusher.-web implant.-introducer.Items not returned for evaluation: -dispenser hoop.-microcatheter.-controller.The web implant was returned still attached to the pusher for analysis and was returned within the introducer.Upon inspection of returned items, the web implant was found to be within visual and dimensional specifications.However, the pusher hypotube was found kinked at the middle section and the proximal connector was also kinked at the brown lead wire joint.Tested the returned device with an in-house controller and gave red lights.The delivery system resistance was measured to be out of specification due to the connector damage.The implant was accidentally detached from the pusher during the investigation.The heater coil section was dissected to investigate any obstruction that could possibly prevent the implant from detaching, and the heater coil was found to be stretched which is 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 heater coil did show signs of controller activation as indicated by the melted tether and pet.The heater coil winding damage likely also contributed to the failed continuity and resistance testing.The investigation of the returned web system found the pusher hypotube kinked at the middle section, the proximal connector kinked at the brown lead wire joint, and the heater coil windings stretched.The device failed continuity and resistance testing due to the damaged proximal connector and heater coil windings.However, the implant tether and heater coil pet were found melted, indicating that the device was activated using a detachment controller during the procedure; therefore, the damage to the proximal connector and 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 physical evaluation of the device could not identify the conditions or circumstances that led to the pusher damage, but the damage is consistent with the device experiencing forces exceeding the pusher's yield strength.

• 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: 20446652
• Report Number: 2032493-2024-00756
• Device Sequence Number: 8324177
• Product Code: OPR
• UDI-Device Identifier: 00842429110812
• UDI-Public: (01)00842429110812(11)221221(17)251130(10)0000301032
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 11/08/2024

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: 11/30/2025
• Device Model Number: W5-4-2-MVI-3
• Device Lot Number: 0000301032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2024
• 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: 09/18/2024
• Supplement Date Received by Manufacturer: 10/15/2024
• Initial Report FDA Received Date: 10/14/2024
• Supplement Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2022
• 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: VIA CATHETER
• Patient Age: 68 YR
• Patient Sex: Female