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

Model Number	W5-7-2-MVI-3
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the web device experienced a delayed detachment.When retrieving the device, the web detached in the via.Returning via with web inside.A 6x3 was used in it¿s place.Patient doing well.No patient injury was reported.
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.
Additional Manufacturer Narrative
Items returned for evaluation: -delivery system (pusher) -web implant -introducer -via 17 microcatheter.Items not returned for evaluation: -dispenser hoop -controller.The web implant was returned separated from the pusher within the distal end of the microcatheter.Upon inspection of returned items, the web implant was found to be within visual and dimensional specifications.However, the proximal connector was kinked at the lead wire joints.Tested the returned device with an in-house controller and gave red lights.The delivery system resistance was measured out of specification due to the connector damage.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.No damage or kinks were observed on the returned via 17 microcatheter.The investigation of the returned web system found the implant separated from the delivery system, the proximal connector kinked, and the heater coil windings stretched.The device failed continuity and resistance testing due to the damaged connector and heater coil windings, which is consistent with the alleged detachment issue.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 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 connector damage, but the damage is consistent with the device experiencing forces over specification.No damage was found on the returned microcatheter that would have caused or contributed to the reported complaint.
Event or Problem Description
It was reported that the web device experienced a delayed detachment.When retrieving the device, the web detached in the via.Returning via with web inside.A 6x3 was used in it¿s place.Patient doing well.No patient injury was reported.

• 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: 19454713
• Report Number: 2032493-2024-00440
• Device Sequence Number: 20605408
• Product Code: OPR
• UDI-Device Identifier: 00842429118009
• UDI-Public: (01)00842429118009(11)230503(17)260430(10)0000355661
• 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): 07/01/2024

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: 04/30/2026
• Device Model Number: W5-7-2-MVI-3
• Device Lot Number: 0000355661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2024
• 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: 05/10/2024
• Supplement Date Received by Manufacturer: 06/06/2024
• Initial Report FDA Received Date: 06/03/2024
• Supplement Report FDA Received Date: 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2023
• 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: SOFIA 5F 125; VIA 17
• Patient Sex: Unknown