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

Model Number	W5-7-4-MVI-3
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	07/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A search for non-conformance's 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.A portion of the device was stated to be available for return to the manufacturer for analysis.However, the device has not been returned.The alleged product issue could not be confirmed.If more information or the device is received at a later date, an investigation will be performed a supplemental report will be submitted.
Event or Problem Description
It was reported that during treatment of an acom aneruysm with a web device, the web needed to be repositioned.The resheating of the web was difficult, but it was placed again, which was successful.The web device required six attempts to detach it.After the detachment, a small clot was observed at the proximal marker of the web.Aggrastat was administered.The patient was reported to be ¿well off.¿.
Additional Manufacturer Narrative
Items returned for evaluation: delivery system (pusher), microcatheter.Items not returned for evaluation: web implant, introducer, dispenser hoop, controller.The visual analysis of the returned items found the implant to be separated from delivery system, and the hypotube kinked at the distal section.The implant was not returned for evaluation.The heater coil section was dissected to investigate any obstruction that could possibly prevent the implant from detaching.The heater coil was not found to be stretched; however, it did exhibit signs of activation using a detachment controller.Further investigation found the brown lead wire broken at the distal solder joint.Tested the returned device with an in-house controller and gave red lights.The delivery system resistance was measured to be ol (spec= 66-78), which is out of specification due to the broken lead wire.The investigation of the returned web system found the hypotube kinked at the distal section and the brown lead wire broken at the distal solder joint.The implant was not returned for evaluation as it was eventually detached as described in the reported event.The device failed continuity and resistance testing.However, the heater coil pet and tether were found burnt, indicating that the device was activated using a detachment controller during the procedure; therefore, the breakage of the brown lead wire at the distal solder joint likely occurred post-activation.The physical evaluation of the device could not identify the conditions or circumstances that led to the pusher and lead wire damage, but the damage is consistent with the device experiencing forces over specification.The detachment controller used in the procedure was not returned, so the investigation could not determine if it had caused or contributed to the reported complaint.
Event or Problem Description
It was reported that during treatment of an acom aneurysm with a web device, the web needed to be repositioned.The resheating of the web was difficult, but it was placed again, which was successful.The web device required six attempts to detach it.After the detachment, a small clot was observed at the proximal marker of the web.Aggrastat was administered.The patient was reported to be ¿well off.¿.

• Brand Name: WEB
• Common Device Name: INTRASACCULAR FLOW DISRUPTION DEVICES
• 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: 19969329
• Report Number: 2032493-2024-00607
• Device Sequence Number: 18383035
• Product Code: OPR
• UDI-Device Identifier: 00842429110935
• UDI-Public: 00842429110935
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P170032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 10/08/2024

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 Model Number: W5-7-4-MVI-3
• Device Catalogue Number: W5-7-4
• Device Lot Number: 0000495182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2024
• Supplement Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2024
• Is the Device Labeled for Single Use? (Y/N): No
• 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 Sex: Female