MAUDE Adverse Event Report: MICROVENTION INC. WEB SL; INTRASACCULAR FLOW DISRUPTION DEVICE

Model Number W5-5-2-MVI-3

Device Problems Device Dislodged or Dislocated (2923); Difficult or Delayed Separation (4044)

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

Event Date 06/01/2022

Event Type  Injury  

Manufacturer Narrative

A search for non-conformance 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 received and the investigation ongoing.Once the investigation is completed, a supplement report will be submitted.

Event Description

It was reported that a web device was attempted to be implanted into the aneurysm.When detaching the web, it was observed under fluoro the pusher wire was partially separated.After unsuccessful attempts were made to detach the pusher wire, a catheter was able to separate the pusher wire by applying tension.Then, the web detached and moved slightly out of the neck of the aneurysm.A synchro wire was placed into the a2 with the catheter tracked over the wire to push the web deeper into the aneurysm clearing the vessel encroachment successfully.Vessels at level of acom patent with brisk flow.The patient is stable.

Manufacturer Narrative

The investigation of the returned web system found the hypotube kinked, the proximal connector bent, and the implant not attached to the delivery system.The device passed continuity and resistance testing.Further inspection found the heater coil damaged, which could have caused the tether to get stuck and have a sticky detachment during the procedure.However, the web implant was not returned, and no procedural images were received for evaluation therefore, this investigation could not analyze the device for the alleged web movement post-detachment as stated in the reported complaint.The physical evaluation of the device could not identify the conditions or circumstances that led to the damage, but the damage is consistent with the device experiencing forces over specification.

• Brand Name: WEB SL
• Type of Device: INTRASACCULAR FLOW DISRUPTION DEVICE
• Manufacturer (Section D): MICROVENTION INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrance callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 14708055
• MDR Text Key: 294291923
• Report Number: 2032493-2022-00233
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 00842429110843
• UDI-Public: (01)00842429110843(11)220426(17)250331(10)0000182619
• 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,Followup
• Report Date: 06/01/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: W5-5-2-MVI-3
• Device Catalogue Number: W5-5-2
• Device Lot Number: 0000182619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/13/2022
• Initial Date FDA Received: 06/15/2022
• Supplement Dates Manufacturer Received: 06/13/2022
• Supplement Dates FDA Received: 07/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male