MAUDE Adverse Event Report: MICROVENTION, INC. WEB SL; INTRASACCULAR DEVICES

Model Number	W5-7-3-MVI-3
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Items returned for evaluation: -delivery system (pusher).-web implant.Items not returned for evaluation: -introducer.-dispenser hoop.-microcatheter.-controller.The visual analysis of the returned items found the web implant to be separated from the delivery system.Upon inspection of returned items, the web implant was found to be within visual and dimensional specifications (spec: diameter(mm)= 7.0 ± 0.7, height(mm)= 3.0 ± 0.4), but the hypotube was found kinked at the hypotube to connector junction.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 with as indicated by the melted tether and pet.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 heater coil winding damage.The investigation of the returned web system found the pusher hypotube kinked, the implant separated from the delivery system, and the heater coil windings stretched.The device failed continuity and resistance testing due to the damaged heater coil windings.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 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 hypotube kink, but the kink is consistent with the device experiencing forces over specification.A search for non-conformances associated with the reported part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The instructions for use (ifu) identifies coil difficult or non-detachment as potential complications associated with use 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.
Event or Problem Description
It was reported that the web device didn¿t detach.After multiple attempts with the detacher to detach the device unsuccessfully the web was recaptured and removed from the patient.The web did detach in the catheter on removal and was successfully removed from the patient.A second device was successfully used.No patient injury was reported.

• Brand Name: WEB SL
• Common Device Name: INTRASACCULAR 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: 18938036
• Report Number: 2032493-2024-00227
• Device Sequence Number: 12505435
• Product Code: OPR
• UDI-Device Identifier: 00842429110928
• UDI-Public: (01)00842429110928(11)221021(17)250930(10)0000275393
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/06/2024

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: 09/30/2025
• Device Model Number: W5-7-3-MVI-3
• Device Lot Number: 0000275393
• Was Device Available for Evaluation?: Yes
• 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: 03/06/2024
• Initial Report FDA Received Date: 03/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown