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

Model Number W5-4-2-MVE

Device Problem Migration (4003)

Patient Problems Hematoma (1884); Embolism/Embolus (4438); Thrombosis/Thrombus (4440)

Event Date 07/22/2022

Event Type  Injury  

Manufacturer Narrative

The lot number was not provided; therefore, a search for production-related ncrs could not be performed the device remains implanted in the patient and could not be returned for analysis; therefore, the alleged product issue cannot be confirmed.The instructions for use (ifu) identifies migration or misplacement as potential complications associated with use of the device.

Event Description

It was reported that the physician was treating an acom aneurysm.The next day the patient was having some leg symptoms.An angiogram was performed and discovered the web had migrated into the a2 vessel.It was decided to leave the device due to clots formed around the migrated web device.The original acom aneurysm was retreated, and a web sls device was placed along with a stent.

• Brand Name: WEB SL
• Type of Device: INTRASACCULAR FLOW DISRUPTION DEVICE
• 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: 15262745
• MDR Text Key: 298280256
• Report Number: 2032493-2022-00310
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: W5-4-2-MVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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