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

Model Number	W4-5-3-MVI-3
Medical Device Problem Codes	Separation Failure (2547); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2020
Type of Reportable Event	Serious Injury
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 was returned to the manufacturer for evaluation.The investigation is underway.The instructions for use identifies premature detachment as a potential complication associated with use of the device.
Event or Problem Description
It was reported that during detachment of the web in an acom aneurysm, the microcatheter and the web were inadvertently pulled out of the aneurysm and the web detached at the right ica/mca bifurcation.The web was successfully secured to the vessel wall at the bifurcation with two stents.There was no reported patient injury.The patient is currently reported to be recovering and has no deficits.
Additional Manufacturer Narrative
The investigation of the returned web device found the implant to be separated from the pusher and not returned.Inspection of the pusher found no evidence of activation at the heater coil section.The monofilament could not be extracted to inspect the profile; however, since there is no evidence of thermal detachment, it was determined that the separation of the implant would have occurred due to the device experiencing retraction forces that exceeded the tensile strength of the monofilament.Further inspection of the pusher found the proximal connector to be severely damaged.If this damage were present at the time of the procedure, it would not be possible to detach the implant normally using a detachment controller.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 SLS
• Common Device Name: INTRASACCULAR FLOW DISRUPTION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 11219969
• Report Number: 2032493-2021-00024
• Device Sequence Number: 17092601
• Product Code: OPR
• UDI-Device Identifier: 00842429106990
• UDI-Public: (01)00842429106990(11)200605(17)250531(10)200605124
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P170032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2021

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: Other
• Device Expiration Date: 05/31/2025
• Device Model Number: W4-5-3-MVI-3
• Device Catalogue Number: W4-5-3
• Device Lot Number: 200605124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2020
• Supplement Date Received by Manufacturer: 01/12/2021
• Initial Report FDA Received Date: 01/23/2021
• Supplement Report FDA Received Date: 02/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention