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

Model Number W5-6-3-MVI

Device Problems Separation Failure (2547); Difficult or Delayed Separation (4044)

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

Event Date 05/14/2023

Event Type  Injury  

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 is reported 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.

Event Description

It was reported that during treatment of an acom aneurysm of a patient with severe sah, the web device was pre-tested successfully.The web was deployed within the aneurysm however, did not detach with multiple attempts.Manipulation was performed by using the microcatheter over the detachment zone and pulling the delivery wire.The web detached within the microcatheter and was aspirated with a sofia catheter successfully.No patient harm or injury was reported.

Manufacturer Narrative

Returned items: delivery system (pusher); implant web.Non-returned items: controller; microcatheter; dispenser hoop; introducer.The visual analysis of the returned items found the implant to be detached from the pusher, and the pusher kinked at the overcoil to hypotube transition.The heater coil section was dissected to investigate any obstruction that could possibly prevent the implant from detaching during the procedure, 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.Tested the returned device with an in-house controller and gave red lights.The pusher resistance was measured to be ol (spec= 66-78), which is out of specification due to the heater coil and pusher damage.However, the implant was found to have a melted tether which indicates that there was thermal activation from a detachment controller.

• 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: 17015218
• MDR Text Key: 316090818
• Report Number: 2032493-2023-00754
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 00842429102138
• UDI-Public: (01)00842429102138(11)221107(17)271031(10)0000281929
• 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: 08/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: W5-6-3-MVI
• Device Lot Number: 0000281929
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/15/2023
• Initial Date FDA Received: 05/26/2023
• Supplement Dates Manufacturer Received: 05/15/2023
• Supplement Dates FDA Received: 08/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2023
• 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
• Patient Outcome(s): Required Intervention