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

Model Number	W5-4.5-2-MVI-3
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	08/15/2022
Type of Reportable Event	Serious Injury
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 pusher of the device was returned to the manufacturer for evaluation.The investigation is ongoing.The instructions for use (ifu) identifies vascular thrombosis as a potential complication associated with use of the device.
Event or Problem Description
It was reported that a web device had trouble detaching during placement.Multiple detachment devices were used and the web eventually detached.The web was noticed to be encroaching on the parent vessel, so a stent was placed to hold the web in place.Post-placement of the stent, clot was noticed.The patient was reported to be "doing well" two days after the procedure.
Additional Manufacturer Narrative
The investigation of the returned delivery system found the middle section smashed and the proximal end kinked; however, it was still able to be inserted into an in-house controller.The funnel diameter of the returned controllers were found to be out of specification, which caused the delivery system to experience friction during the attempt at insertion, which is consistent with the alleged product issue.Further investigation of the delivery system found the yellow lead wire broken at the proximal solder joint, which would have caused or contributed to the detachment issues observed during the procedure.This damage is consistent with the proximal end of the delivery system experiencing forces over specification during the multiple failed attempts at trying to insert into the various detachment controllers during the procedure, as described in the reported event.
Additional Manufacturer Narrative
Corrections: h1 - serious injury.

• 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: 15317447
• Report Number: 2032493-2022-00345
• Device Sequence Number: 20125120
• Product Code: OPR
• UDI-Device Identifier: 00842429110799
• UDI-Public: (01)00842429110799(11)220617(17)250531(10)0000208744
• 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
• Device Implanted Year: 2022
• 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,Followup
• Report Date (Section B): 05/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: W5-4.5-2-MVI-3
• Device Catalogue Number: W5-4.5-2
• Device Lot Number: 0000208744
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2022
• Supplement Date Received by Manufacturer: 09/13/2022; 05/09/2024
• Initial Report FDA Received Date: 08/29/2022
• Supplement Report FDA Received Date: 09/16/2022; 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown