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

Model Number W5-5-2-MVI-3

Device Problem Separation Failure (2547)

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

Event Date 11/27/2023

Event Type  malfunction  

Manufacturer Narrative

Imaging review: a single radiographic image is provided; it is not labeled as to time or date.Magnified ap single shot radiograph, unsubtracted, no contrast, centered over right skull base.A guiding catheter is seen in the presumed region of the petrocavernous junction.A microcatheter extends from the guiding catheter to the proximal vertical m2 segment; there is no guidewire.An intact web is seen inside the microcatheter at the level of the proximal petrous ica.This image does not explain why the web detached inside the microcatheter while being retrieved.The investigation of the returned web system found the proximal connector kinked, and the heater coil windings stretched.The device failed continuity and resistance testing due to the damaged connector and heater coil windings, which is consistent with the alleged detachment issue.However, the heater coil pet and implant tether were found melted, indicating that the device was activated using a detachment controller during the procedure; therefore, the damage to the 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 pusher damage, but the damage is consistent with the device experiencing forces over specification.

Event Description

It was reported, web was implanted in aneurysm and ready to detach.Physician made sure system was in neutral and proceeded to detach.Upon detachment, a slight movement of the web detachment zone was visiualized.The physician proceeded to pull web wire.As the physician pulled the web wire, the via 17 moved forward and covered the marker.Upon futher pulling of the web wire, the web began to resheath.The phsyican did this a total of three times, including multiple detachment sequences were attempted with 2 units.The physician decided to take the web out and use a new one.The physician resheathed the web fully and gained access into the aneurysm.The web detached in the via as he pulled back on the web wire.He had to remove via, and access again.It was reported there was no health damage.

• 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
• MDR Report Key: 18862191
• MDR Text Key: 337767016
• Report Number: 2032493-2024-00201
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 00842429110843
• UDI-Public: (01)00842429110843(11)230621(17)260531(10)0000379962
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/07/2024

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-3
• Device Lot Number: 0000379962
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/21/2024
• Initial Date FDA Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2023
• 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
• Treatment: DETACHER X2; VIA 17 MICROCATHETER