MAUDE Adverse Event Report: MICROVENTION, INC. WEB SL; INTRASACCULAR DEVICES

Model Number	W5-6-2-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	10/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a web device was deployed into an aneurysm without difficulty.It was resheathed and redeployed two times to achieve optimal placement.Three detachment attempts were made with the controller and the device partially detached.The catheter was advanced and used to detach the web from the pusher.There was no intervention.The patient was stable and intact post procedure.
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 returned to the manufacturer for evaluation.The investigation is currently ongoing.
Event or Problem Description
It was reported that a web device was deployed into an aneurysm without difficulty.It was resheathed and redeployed two times to achieve optimal placement.Three detachment attempts were made with the controller and the device partially detached.The catheter was advanced and used to detach the web from the pusher.There was no intervention.The patient was stable and intact post procedure.
Additional Manufacturer Narrative
Items returned for evaluation: -delivery system (pusher) -web implant 8x5 -introducer -via 27 microcatheter items not returned for evaluation: -dispenser hoop -controller -web implant 6x2 visual analysis of the returned items found the web device returned partially advanced into the via 27 microcatheter, and the hypotube kinked at the hypotube to connector junction.Upon further inspection, it was found that the size of the returned web implant differed from the reported implant size.The web size specified in the reported complaint was 6x2; however, the measurement of the returned web implant was 8x5.Further investigation was conducted to see whether the returned device exhibited a detachment issue.Tested the returned device with an in-house controller and gave red lights.However, the delivery system resistance was measured to be 69.1 (spec= 66-78), which is within specification.The heater coil section was dissected to investigate any obstruction that could possibly prevent the implant from detaching, but the heater coil did not show signs of activation using a detachment controller.The continuity testing failure may be attributed to the kink observed on the hypotube.The reported complaint is non-verifiable as the incorrect device was returned for evaluation.The web size specified in the reported complaint was 6x2; however, the measurement of the returned web implant was 8x5.Without the return and physical evaluation of the reported device, the investigation cannot definitively determine if a condition existed that would have caused or contributed to the reported event.

• Brand Name: WEB SL
• Common Device Name: INTRASACCULAR DEVICES
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 18071050
• Report Number: 2032493-2023-01032
• Device Sequence Number: 7665677
• Product Code: OPR
• UDI-Device Identifier: 00842429117996
• UDI-Public: (01)00842429117996(11)230419(17)260331(10)0000348500
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P170032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 12/13/2023

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: 03/31/2026
• Device Model Number: W5-6-2-MVI-3
• Device Lot Number: 0000348500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2023
• 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: 10/16/2023
• Supplement Date Received by Manufacturer: 11/22/2023
• Initial Report FDA Received Date: 11/06/2023
• Supplement Report FDA Received Date: 12/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2023
• 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
• Patient Sex: Unknown