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

Model Number	W5-5-2
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2024
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.Potential complications as referenced on the ifu, include but are not limited to the following: hematoma at the site of entry, aneurysm rupture, emboli, vessel perforation, parent artery occlusion, hemorrhage, ischemia, vasospasm, clot formation, device migration or misplacement, premature or difficult device detachment, non-detachment, incomplete aneurysm filling, revascularization, post-embolization syndrome, and neurological deficits including stroke and death.The device was stated to be available for return to the manufacturer for evaluation but has not yet been returned despite a device return attempt.Ongoing attempts will be made for the device return.The alleged product issue/event as described could not be confirmed.If the device is received at a later date, an investigation will be performed and a supplemental mdr will be submitted.
Event or Problem Description
As reported: when the web was attempted to be detached with the detachment controller, red light was on.Web was not detached and both web and detachment controller are replaced with new ones and the procedure was complete successfully.Patient is stable.
Event or Problem Description
As reported: when the web was attempted to be detached with the detachment controller, red light was on.Web was not detached and both web and detachment controller are replaced with new ones and the procedure was complete successfully.Patient is stable.
Additional Manufacturer Narrative
Corrected country in section e from "china" to "south korea".
Additional Manufacturer Narrative
Items returned for evaluation: pusher, web implant, introducer, dispenser hoop.Items not returned for evaluation: controller.The web implant was returned still attached to the pusher for analysis and was returned within the introducer.Upon inspection of returned items, the web implant was found to be within visual and dimensional specifications.However, the proximal connector was found kinked at the brown lead wire joint.The proximal connector was corrected and tested for continuity using an in-house controller and gave red lights.The delivery system resistance was measured and found to be out of specification due to the connector damage.The heater coil section was dissected to investigate any obstruction that could possibly prevent the implant from detaching, but the heater coil was not found stretched and did not show signs of activation using a detachment controller.The investigation of the returned web system found the proximal connector kinked at the brown lead wire joint.The unit did not pass continuity and resistance testing.The kinked proximal connector may have caused or contributed to the reported non-detachment.The physical evaluation of the device could not identify the conditions or circumstances that led to the proximal connector kink, but the kink is consistent with the device experiencing forces exceeding the proximal connector's yield strength.
Event or Problem Description
As reported: when the web was attempted to be detached with the detachment controller, red light was on.Web was not detached and both web and detachment controller are replaced with new ones and the procedure was complete successfully.Patient is stable.

• 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: 20140637
• Report Number: 2032493-2024-00660
• Device Sequence Number: 7462069
• Product Code: OPR
• UDI-Device Identifier: 00842429110843
• UDI-Public: (01)00842429110843(11)230105(17)271231(10)0000389706
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Followup
• Report Date (Section B): 10/04/2024

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 Model Number: W5-5-2
• Device Lot Number: 0000389706
• 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: 08/20/2024
• Supplement Date Received by Manufacturer: 09/18/2024; 10/04/2024
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 09/23/2024; 10/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DETACHMENT CONTROLLER WDC.
• Patient Sex: Unknown