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	Brain Injury (2219)
Date of Event	07/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a web device was deployed in an acom aneurysm but would not detach after three detachment attempts with a detachment controller.The microcatheter was moved forward, resulting in the web's detachment, but also resulting in the web shifting position within the aneurysm and impinging upon the parent vessel.While navigating past the aneurysm with a wire in order to place a stent, the web dislodged and floated downstream into the aca.A snare device was used to retrieve it, but was ultimately unsuccessful and the web was pushed further to a distal aca branch at a bifurcation.A stent was placed to retain patency of the distal aca vessels and to hold the web in place.Follow up imaging showed all branches still filling at time of procedure end.The acom aneurysm was left untreated at this time.Patient was started on an aggrastat drip for 12 hours with repeat diagnostic angiogram to follow in the morning.The angiogram revealed that the vessel are currently wide open.The patient presents with expressive aphasia that the physician believes is from manipulations from trying remove the web.
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 for evaluation.The investigation is currently ongoing.
Additional Manufacturer Narrative
The reported complaint is non-verifiable.The investigation of the returned web system found the delivery system kinked between the hypotube and connector.The investigation did not find any damage on the heater coil that could have caused the tether to get stuck and have a sticky detachment.The sticky detachment cannot be completely verified based on the information provided.The web implant was not returned; however, the procedural images show that the web implant did shift positions to the a1/a2 bifurcation and then migrated to the pericallosal/callosomarginal bifurcation of the a2, post-detachment.The physical evaluation of the device could not identify the conditions or circumstances that led to the delivery system 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: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 15131951
• Report Number: 2032493-2022-00300
• Device Sequence Number: 5619661
• Product Code: OPR
• UDI-Device Identifier: 00842429110799
• UDI-Public: (01)00842429110799(11)211109(17)241031(10)0000115026
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: P170032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2022

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: 10/31/2024
• Device Model Number: W5-4.5-2-MVI-3
• Device Catalogue Number: W5-4.5-2
• Device Lot Number: 0000115026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2022
• Supplement Date Received by Manufacturer: 08/29/2022
• Initial Report FDA Received Date: 07/29/2022
• Supplement Report FDA Received Date: 09/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 34 KG