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

Model Number W5-4.5-3-MVI

Device Problem Difficult or Delayed Separation (4044)

Patient Problems Hemorrhage/Bleeding (1888); Ruptured Aneurysm (4436)

Event Date 01/16/2023

Event Type  Injury  

Event Description

It was reported that after placing the web in the aneurysm, they were unable to detach the web with the use of 4 different wdc-2 controllers.The physician made multiple attempts; however, the aneurysm ruptured so they were unable to remove the web.The physician then pulled on the pusher to break the detachment zone (the coupler).The patient was reported to have encountered a subarachnoid hemorrhage, and is in intensive care with the installation of a ventricular bypass.

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 difficult delayed detachment resulting in aneurysm rupture 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.

Manufacturer Narrative

The investigation of the returned web system found the proximal connector kinked, the pusher overcoil kinked, the hypotube kinked, and the heater coil windings damaged.The implant was detached from the delivery system and was not returned for evaluation.The unit did not pass continuity testing and resistance testing, which is consistent with the damaged heater coil windings.However, the heater coil pet was returned melted, indicating that the device was activated using a detachment controller during the procedure; therefore, the damage to the heater coil windings likely occurred during the pusher retraction as described in the reported event.Further inspection of the heater coil found the windings to also be stretched.This condition is consistent with the web implant getting caught in between the windings due to the implant tether increasing in diameter as it gets heated from the thermal activation of the detachment controller and exceeding the inner diameter of the heater coil, resulting in the web sticking to the pusher post-activation.However, this investigation could not verify if the tether did exceed the inner diameter of the heater coil since the implant was not returned for evaluation.The physical evaluation of the device could not identify the conditions or circumstances that led to the delivery system kinks, but the kinks are consistent with the device experiencing forces over specification.

Event Description

Please see h10 for investigation results.

• 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 callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 16301876
• MDR Text Key: 308822188
• Report Number: 2032493-2023-00551
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 00842429102060
• UDI-Public: (01)00842429102060(11)220629(17)270531(10)0000212715
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: W5-4.5-3-MVI
• Device Lot Number: 0000212715
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2022
• 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
• Patient Outcome(s): Required Intervention