MAUDE Adverse Event Report: MICROVENTION WEB SL; INTRASACCULAR DEVICES

Model Number	W5-5-3-MVI-3
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2024
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.The device was stated to be available for return to the manufacturer for evaluation but has not yet been returned.The reported issue 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.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 a web device was successfully placed in the aneurysm and delivered a successful detachment charge, but the device did not detach.Multiple attempts were performed to detach the web but would not detach from the wire.The device was removed, and a new device was successfully implanted.The patient was reported to be stable and was discharged.No patient harm or injury was reported.
Event or Problem Description
Additional information noted that the detachers were discarded by the user facility.
Additional Manufacturer Narrative
B5: additional information provided.Investigation findings.Items returned for evaluation: delivery system pusher; web implant; via 17 microcatheter.Items not returned for evaluation: introducer; dispenser hoop; 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 (spec: diameter(mm)= 5.0 ± 0.5, height(mm)= 3.0 ± 0.4).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.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.The heater coil did show signs of controller activation with an indication of a melted tether and pet.The heater coil winding damage likely also contributed to the failed continuity and resistance testing.No damage was found on the returned via 17 microcatheter.Investigation conclusion: the investigation of the returned web system found the heater coil windings stretched.The heater coil pet was 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 investigation of the returned device did not find any other damage or anomaly that would have caused or contributed to the reported complaint.

• Brand Name: WEB SL
• Common Device Name: INTRASACCULAR DEVICES
• Manufacturer (Section D): MICROVENTION; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 19245910
• Report Number: 2032493-2024-00358
• Device Sequence Number: 6438315
• Product Code: OPR
• UDI-Device Identifier: 00842429110850
• UDI-Public: (01)00842429110850(11)221019(17)250930(10)0000273207
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 05/21/2024

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: W5-5-3-MVI-3
• Device Lot Number: 0000273207
• 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: 04/15/2024
• Supplement Date Received by Manufacturer: 05/13/2024
• Initial Report FDA Received Date: 05/06/2024
• Supplement Report FDA Received Date: 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2022
• 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
• Patient Sex: Unknown