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

Model Number	W5-6-3-MVI-3
Medical Device Problem Codes	Difficult to Remove (1528); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the web device was used for treatment of an aneurysm in the internal carotid artery (ica).Reportedly, when the web was placed in the aneurysm and attempted to be detached using a detachment controller, the device did not detach despite multiple detachment cycle and a second detachment controller.The physician advanced a microcatheter with tension on the wire but the web came back out of aneurysm into parent vessel while still attached to delivery wire.The physician was unable to re-sheath the web into the microcatheter.Reportedly, the web detached into the parent vessel when a support catheter was brought up to re-sheath the device.Multiple attempts to remove the web with a snare device failed.The physician decided to bring the web to a safe location in the ica and successfully deployed a wallstent across trapping and securing the web device.The patient was stable, neurologically intact, and was discharged home.
Additional Manufacturer Narrative
A search for non-conformances associated with the reported part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device remains impanted in the patient; therefore, the alleged product issue cannot be confirmed.The instructions for use (ifu) identifies difficult coil detachment as potential complications associated with use of the device.
Additional Manufacturer Narrative
Additional information: g3, h6, h10 (summary device evaluation).Correction: h10 (ifu statement).Summary device evaluation: the web device remains implanted in the patient; however, (b)(4) detachment controllers used in the procedure were returned to the manufacturer for analysis.The investigation of the returned detachment controllers found the battery voltage, board voltage and output to be within specification; furthermore, the light and audio sequences functioned normally for all (b)(4) controllers.However, the web device used during the procedure was not returned for evaluation.Since the web device was not returned and procedure images were not provided for evaluation, the investigation could not test for the alleged detachment difficulty issue or determine the cause of the alleged web detachment in the parent vessel; therefore, this complaint is considered non-verifiable.The instructions for use (ifu) identifies premature web detachment as potential complications associated with use of the device.

• 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: 15499446
• Report Number: 2032493-2022-00374
• Device Sequence Number: 5920334
• Product Code: OPR
• UDI-Device Identifier: 00842429110881
• UDI-Public: (01)00842429110881(11)220627(17)250531(10)0000212721
• 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: 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
• Report Date (Section B): 09/12/2022

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 Expiration Date: 05/31/2025
• Device Model Number: W5-6-3-MVI-3
• Device Catalogue Number: W5-6-3
• Device Lot Number: 0000212721
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2022
• Supplement Date Received by Manufacturer: 10/18/2022
• Initial Report FDA Received Date: 09/28/2022
• Supplement Report FDA Received Date: 10/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2022
• 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 17 MICROCATHETERSOFIA 5FR CATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female