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

Model Number	W5-5-2-MVI-3
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A search for non-conformance 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 received and the investigation ongoing.Once the investigation is completed, a supplement report will be submitted.
Event or Problem Description
It was reported that a web device was attempted to be implanted into the aneurysm.When detaching the web, it was observed under fluoro the pusher wire was partially separated.After unsuccessful attempts were made to detach the pusher wire, a catheter was able to separate the pusher wire by applying tension.Then, the web detached and moved slightly out of the neck of the aneurysm.A synchro wire was placed into the a2 with the catheter tracked over the wire to push the web deeper into the aneurysm clearing the vessel encroachment successfully.Vessels at level of acom patent with brisk flow.The patient is stable.
Additional Manufacturer Narrative
The investigation of the returned web system found the hypotube kinked, the proximal connector bent, and the implant not attached to the delivery system.The device passed continuity and resistance testing.Further inspection found the heater coil damaged, which could have caused the tether to get stuck and have a sticky detachment during the procedure.However, the web implant was not returned, and no procedural images were received for evaluation therefore, this investigation could not analyze the device for the alleged web movement post-detachment as stated in the reported complaint.The physical evaluation of the device could not identify the conditions or circumstances that led to the damage, but the damage is consistent with the device experiencing forces over specification.

• Brand Name: WEB SL
• Common Device Name: INTRASACCULAR FLOW DISRUPTION DEVICE
• Manufacturer (Section D): MICROVENTION INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrance callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 14708055
• Report Number: 2032493-2022-00233
• Device Sequence Number: 2235659
• Product Code: OPR
• UDI-Device Identifier: 00842429110843
• UDI-Public: (01)00842429110843(11)220426(17)250331(10)0000182619
• 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): 06/01/2022

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: 03/31/2025
• Device Model Number: W5-5-2-MVI-3
• Device Catalogue Number: W5-5-2
• Device Lot Number: 0000182619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2022
• Supplement Date Received by Manufacturer: 06/13/2022
• Initial Report FDA Received Date: 06/15/2022
• Supplement Report FDA Received Date: 07/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2022
• 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 Age: 70 YR
• Patient Sex: Male