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

Model Number W5-4-3-MVI

Device Problem Separation Failure (2547)

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

Event Date 02/28/2024

Event Type  malfunction  

Event Description

As reported, during an emergency embolization of an acom aneurysm it wasn`t possible to detach the web device.Detachment attempts were made with 3 web-detachement-controllers and tried 3 times per controller.In the end they re-sheathed the web and took a used a new one.No patient injury was reported.

Manufacturer Narrative

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 device was available but has not been returned to the manufacturer for analysis; therefore, the alleged product issue cannot be confirmed.If the device or additional information is received, microvention, inc., will submit a supplemental report.The instructions for use (ifu) identifies coil 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.

Manufacturer Narrative

Items returned for evaluation: delivery system (pusher).Web implant.Introducer.Items not returned for evaluation: dispenser hoop.Microcatheter.Controller.The web implant was returned still attached to the pusher for analysis and was returned within the introducer.Upon inspection, the web implant was found to be within visual and dimensional specifications (spec: diameter(mm)= 4.0 , 0.4, height(mm)= 3.0 , 0.4), but the hypotube was found kinked at the proximal section.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 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.The investigation of the returned web system found the hypotube kinked at the proximal section 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.

• 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: 18927433
• MDR Text Key: 337953638
• Report Number: 2032493-2024-00225
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 00842429102084
• UDI-Public: (01)00842429102084(11)221018(17)270930(10)0000272184
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: W5-4-3-MVI
• Device Lot Number: 0000272184
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Sex: Male