MAUDE Adverse Event Report: MICROVENTION WEB SL; INTRASACCULAR DEVICES

Model Number W5-5-2-MVI

Device Problem Difficult or Delayed Separation (4044)

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

Event Date 01/17/2024

Event Type  malfunction  

Event Description

It was reported that it was impossible to detach the web.The web was pulled back and it unintentionally detached in the via microcatheter.The web was pushed into the aneurism with good placement.There was no reported patient injury and is in good condition.

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 remains implanted in the patient and not returned to the manufacturer for evaluation.Procedural or medical imaging was not provided.The alleged product issue could not be confirmed.If additional information is received at a later date, a supplemental mdr will be submitted.The instructions for use (ifu) identifies premature web detachment as a potential complication associated with the use of the device.

Manufacturer Narrative

Items returned for evaluation: delivery system- pusher.Items not returned for evaluation: web implant; introducer; dispenser hoop; microcatheter; controller.The visual analysis of the returned items found the implant to be separated from delivery system and the implant was not returned for evaluation.Inspection of the pusher found the hypotube kinked at the hypotube to connector junction, and the proximal connector bent at the solder joints.Tested the returned device with an in-house controller and gave red lights.The delivery system resistance was measured to be (spec= 66-78, which is 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 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 as indicated by the 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 implant separated from the delivery system, the hypotube kinked, the proximal connector kinked, and the heater coil windings stretched.The implant was not returned for evaluation as it was pushed into the aneurysm as described in the reported event.The device failed continuity and resistance testing, which is consistent with the damage to the proximal connector and the heater coil windings.However, the heater coil pet and tether were found melted, indicating that the device was activated using a detachment controller during the procedure; therefore, the damage to the proximal 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 delivery system damage, but the damage is consistent with the device experiencing forces over specification.

• Brand Name: WEB SL
• Type of Device: INTRASACCULAR DEVICES
• Manufacturer (Section D): MICROVENTION; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 18677376
• MDR Text Key: 335591028
• Report Number: 2032493-2024-00108
• 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: 03/10/2024

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: W5-5-2-MVI
• Device Lot Number: 0000225934
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/17/2024
• Initial Date FDA Received: 02/09/2024
• Supplement Dates Manufacturer Received: 02/21/2024
• Supplement Dates FDA Received: 03/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2022
• 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