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

Model Number	W5-4-2
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: unable to detach either web device, multiple detachment controllers wdc were used.Both web devices were used with two controllers.Patient underwent stent assisted coiling due to the web not being able to detach.Patient is well and discharged.The first web device is captured in (b)(6).The second web device is captured in (b)(6).
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.
Additional Manufacturer Narrative
Items returned for evaluation: -delivery system (pusher) -web implant -introducer -3x wdc-2 controller.Items not returned for evaluation: -dispenser hoop -microcatheter.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, but the proximal connector was found kinked at the brown lead wire joint.Tested the returned device with the returned controllers and 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, and the heater coil was found to be stretched, which is an indication that the tether could have been caught in between the coil windings and caused the heater coil to stretch when the delivery system was pulled/retracted during the procedure.The heater coil did show signs of controller activation as indicated by the melted tether and pet.The heater coil winding damage likely also contributed to the failed continuity and resistance testing.The returned controllers were evaluated and were found to be functioning as normal (see controller evaluations below).Controller 1 voltage and duration measurement: the wdc-2 board voltage and firing duration was measured using an oscilloscope.When the wdc-2 was inserted into the test fixture, a green light appeared with normal audio output.The wdc-2 board voltage and duration was found to be within specification.Controller 2 voltage and duration measurement: the wdc-2 board voltage and firing duration was measured using an oscilloscope.When the wdc-2 was inserted into the test fixture, a green light appeared with normal audio output.The wdc-2 board voltage and duration was found to be within specification.Controller 3 voltage and duration measurement: the wdc-2 board voltage and firing duration was measured using an oscilloscope.When the wdc-2 was inserted into the test fixture, a green light appeared with normal audio output.The wdc-2 board voltage and duration was found to be within specification.The investigation of the returned web system found the proximal connector kinked and the heater coil windings stretched.The device failed continuity and resistance testing due to the damaged connector, which is consistent with the alleged detachment issue.However, the heater coil pet and implant tether were found melted, indicating that the device was activated using a detachment controller during the procedure; therefore, the damage to the connector and heater coil windings likely occurred post-activation.The stretched heater coil windings are an indication that the tether could have been caught in between the coil windings and caused the heater coil to stretch when the delivery system was pulled/retracted during the procedure.The physical evaluation of the device could not identify the conditions or circumstances that led to the connector damage, but the damage is consistent with the device experiencing forces over specification.The returned detachment controllers were found to function as intended and would not have caused or contributed to the reported event.
Event or Problem Description
As reported: unable to detach either web device, multiple detachment controllers wdc were used.Both web devices were used with two controllers.Patient underwent stent assisted coiling due to the web not being able to detach.Patient is well and discharged.The first web device is captured in mdr # 2032493-2024-00596.The second web device is captured in mdr # 2032493-2024-00597.

• 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: 19929360
• Report Number: 2032493-2024-00597
• Device Sequence Number: 12797268
• Product Code: OPR
• UDI-Device Identifier: 00842429110812
• UDI-Public: (01)00842429110812(11)220825(17)250731(10)0000246492
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2024

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 Expiration Date: 07/31/2025
• Device Model Number: W5-4-2
• Device Lot Number: 0000246492
• 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: 07/23/2024
• Supplement Date Received by Manufacturer: 08/23/2024
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 08/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2022
• 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 CONTROLLERS WDC
• Patient Age: 58 YR
• Patient Sex: Female