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

Model Number W5-3-2-MVI-2

Device Problem Difficult or Delayed Separation (4044)

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

Event Date 02/27/2024

Event Type  malfunction  

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 returned to the manufacturer for evaluation.The investigation is ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.

Event Description

It was reported that the intrasaccular device would not detach.Many attempts were made to detach the device after being deployed in the aneurysm through the microcatheter.Three different detachment controllers were used with no success (even after wiping off contrast from the detachment zone).The physician attempted the detachment maneuvers with no success and tried detaching by directly placing a 9-volt battery on the detachment zones (on the pusher wire).Upon retrieving the intrasaccular device, it detached inside of the microcatheter.The microcatheter was removed with no harm to the patient, and the physician proceeded to coil the aneurysm.No patient injury occurred.

Manufacturer Narrative

The investigation of the returned web system found the implant to be separated from the delivery system within the distal end of the microcatheter upon receipt as described in the reported event.The returned via 17 microcatheter was found kinked at 7cm and 5cm from the distal tip, which would have caused or contributed to the web implant separating from the delivery system while retrieving the device during the procedure.The delivery system was not returned for evaluation.Since the delivery system was not returned, the investigation could not determine if a condition existed in the electrical circuit that would have caused or contributed to the reported detachment issue; therefore, this complaint is considered non-verifiable.

Event Description

It was reported that the device would not detach.Many attempts were made to detach the device after being deployed in the aneurysm through a via 17.Three different wdc controllers were used with no success (even after wiping off contrast from the detachment zone).Physicians attempted the sticky detachment maneuver with no success.Physicians tried detaching by directly placing a 9-volt battery on the detachment zones (on the pusher wire) with no success.Upon retrieving the device, it detached inside of the via 17.The catheter was removed with no harm to the patient, and the physicians proceeded to coil the aneurysm instead.Device will be sent back as-is inside of the via 17 (via-17-154-01, lot: 0000374186).

• 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: 18981365
• MDR Text Key: 338734717
• Report Number: 2032493-2024-00246
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 00842429103715
• UDI-Public: (01)00842429103715(11)230927(17)280831(10)0000429351
• 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: 05/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: W5-3-2-MVI-2
• Device Lot Number: 0000429351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/27/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1