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

Model Number W4-6-3-CN

Device Problem Separation Failure (2547)

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

Event Date 11/14/2023

Event Type  malfunction  

Event Description

It was reported that the web device was used in an unspecified aneurysm embolization procedure.The web prepped fine and when deployed and attempted to detach, it would not detach despite use of two detachment controllers.The web device was removed from the patient and replaced with another web device to successfully complete the procedure.The patient was fine.

Manufacturer Narrative

Investigation findings: items returned for evaluation: -delivery system (pusher) -web implant -introducer.Items not returned for evaluation: -microcatheter -controller -dispenser hoop.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, but the hypotube was found kinked at the hypotube-connector junction; and the proximal connector was also kinked at the brown lead wire joint.Tested the returned device with an in-house controller and gave red lights.The delivery system resistance was measured 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 slightly 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 an indication of a melted tether and pet.The heater coil winding damage likely also contributed to the failed continuity and resistance testing.Investigation conclusion: the investigation of the returned web system found the hypotube kinked, the proximal connector kinked, and the heater coil windings slightly stretched.The device failed continuity and resistance testing due to the damaged connector and heater coil windings, 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 pusher damage, but the damage is consistent with the device experiencing forces over specification.

• Brand Name: WEB SL
• Type of Device: INTRASACCULAR FLOW DISRUPTION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enerprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92565 ; 7142478000
• MDR Report Key: 18705126
• MDR Text Key: 336432242
• Report Number: 2032493-2024-00131
• Device Sequence Number: 1
• Product Code: OPR
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P170032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/14/2024

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
• Device Operator: Health Professional
• Device Model Number: W4-6-3-CN
• Device Lot Number: 0000131249
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/02/2024
• Initial Date FDA Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2021
• 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: WDC-2 DETACHMENT CONTROLLER.
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 65 KG