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

Model Number W5-4-2-MVI-2

Device Problem Separation Problem (4043)

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

Event Date 12/21/2023

Event Type  malfunction  

Event Description

It was reported during a web embolization procedure, the web failed to detach despite using three different wdc controllers.Other failed attempts were made by manipulating the catheter and pusher wire numerous times, re-sheathing the device, and redeploying it.The web device was removed from the patient.Another attempt was made to detach the web outside the patient, and it worked.There was no patient injury or intervention required.

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 implant separated from the delivery system, the overcoil stretched and damaged at the distal end, the hypotube kinked at the proximal section, the proximal connector kinked at the brown lead wire joint, and 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 physical evaluation of the device could not identify the conditions or circumstances that led to the damage, but the damage is consistent with experiencing forces over specifications.The microcatheter was not returned, so the investigation could not determine if it had caused or contributed to the reported complaint.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.

• Brand Name: WEB SL
• Type of Device: INTRASACCULAR FLOW DISRUPTION DEVICE
• Manufacturer (Section D): MICROVENTION INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callhan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 19009390
• MDR Text Key: 339009316
• Report Number: 2032493-2024-00255
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 00842429103746
• UDI-Public: (01)00842429103746(11)230508(17)280430(10)0000357964
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 03/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: W5-4-2-MVI-2
• Device Lot Number: 0000357964
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2023
• 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