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

Model Number W5-7-4-MVI-3

Device Problem Separation Failure (2547)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/21/2024

Event Type  malfunction  

Event Description

It was reported that an intrasaccular flow disruption device was deployed in the aneurysm and would not detach with a detachment controller.The physician removed the device, inspected it, re-accessed the aneurysm and deployed same device.It would not detach again with two different detachment controllers.A new device was chosen and detached successfully.There was no intervention.The patient was reported to be stable.

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 investigation of the returned web system found the pusher kinked at the proximal section, the proximal connector kinked at the brown lead wire joint, and the heater coil windings stretched.The device failed continuity and resistance testing due to the damaged proximal connector and heater coil windings.However, the heater coil pet and tether were found melted, indicating that the device was activated using a detachment controller during the procedure; therefore, the damage to the proximal 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 delivery system 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.

• Brand Name: WEB SL
• Type of Device: 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: 19076932
• MDR Text Key: 340576423
• Report Number: 2032493-2024-00283
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 00842429110935
• UDI-Public: (01)00842429110935(11)220418(17)250331(10)0000180437
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: W5-7-4-MVI-3
• Device Lot Number: 0000180437
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 5FR 125 SOFIA CATHETER; VIA 17 MICROCATHETER
• Patient Age: 60 YR
• Patient Sex: Female