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

Model Number W5-6-2-MVI

Device Problem Difficult or Delayed Separation (4044)

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

Event Date 01/24/2024

Event Type  malfunction  

Manufacturer Narrative

The device was implanted and therefore not available for return and investigation by the manufacturer.However, the concomitant medical products were stated to be available for return along with the proximal portion of the delivery device.The devices have not been returned to the manufacturer despite multiple attempts.The alleged product issue/event as described could not be confirmed.If the devices are received at a later date, an investigation will be performed and a supplemental mdr will be submitted.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.

Event Description

It was reported, the physician treated a shallow acom aneurysm with the web sl.The physician tried to detach the web with the first web detachment controller and failed.The testing of this web detachment controller showed a green light, and the normal sound and light signal for the detachment.After the 9th try the physician changed to the second wdc-2.The position of the catheter marker and the web marker showed a light ankle.But the web were still at the pusher.The physician tried to reposition the microcatheter and also pulled slightly at the web pusher.The second detachment controller was used for several detachment manuvers.After the 7th try with the second web detachment controller the web were detached.There was no patient injury.The patients current condition is reported as well off.

Manufacturer Narrative

The investigation of the returned web system found the implant to be separated from the delivery system, the hypotube kinked, and the proximal connector broken.The heater coil was found burnt at the distal end, which indicates thermal detachment did occur.The web implant was not returned for evaluation as it was detached during the procedure; however, due to the condition of the delivery system, testing was unable to be performed to determine if a condition existed in the electrical circuit that would have caused or contributed to the reported delayed detachment.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: 18785150
• MDR Text Key: 337185963
• Report Number: 2032493-2024-00160
• Device Sequence Number: 1
• Product Code: OPR
• 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: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: W5-6-2-MVI
• Device Lot Number: 0000364872
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2022
• 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: 1X VIA-17-154-01 BATCH: 0000270384.; 2X WDC-2 BATCH: 0000264028.
• Patient Sex: Male