MAUDE Adverse Event Report: MICROVENTION, INC. WEB SL 17 SINGLE LAYER; INTRASACCULAR FLOW DISRUPTION DEVICE

Model Number	W5-5-2-MVI-3
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Material Deformation (2976); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2022
Type of Reportable Event	Malfunction
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 remains implanted in the patient and not available for return to the manufacturer for analysis; therefore, a product analysis could not be conducted, and the reported issue cannot be confirmed.
Event or Problem Description
It was reported that multiple attempts were made to detach the web device from the pusher wire; however, the web did not detach.A new controller was used and successfully detached the web; however, the technique used by the physician , resulted in the catheter slightly pushing into the web creating an indent on the proximal portion of the web and exaggerated the marker recess.

• Brand Name: WEB SL 17 SINGLE LAYER
• 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: 14294092
• Report Number: 2032493-2022-00176
• Device Sequence Number: 20185364
• Product Code: OPR
• UDI-Device Identifier: 00842429110843
• UDI-Public: (01)00842429110843(11)210419(17)240331(10)21041913J
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/18/2022

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: 03/31/2024
• Device Model Number: W5-5-2-MVI-3
• Device Catalogue Number: W5-5-2
• Device Lot Number: 21041913J
• 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: 04/18/2022
• Initial Report FDA Received Date: 05/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2021
• 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: Female