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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Aneurysm (1708)

Event Type  Injury  

Manufacturer Narrative

The device lot number is unknown; therefore, a search for non-conformances associated with the reported part/lot number combination could not be performed.The device was implanted in the patient and not returned to the manufacturer for analysis.Additionally, procedural images were not provided; therefore, the reported event cannot be confirmed.The instructions for use (ifu) identifies aneurysm perforation or rupture, hemorrhage as potential complications associated with use of the device.

Event Description

As reported through the article titled, "image- based computational hemodynamic analysis of an anterior communicating aneurysm treated with the woven endobridge device", one year post treatment of the patient's acoma aneurysm (9mm height, 10mm dome, with 6mm neck diameter, an aspect ratio of 1.5, and dome-to-neck ration <2) with a web-sl device, the patient's angiography showed recanalization of the aneurysm and the web had been pushed to the dome.

Manufacturer Narrative

Additional information: b5.

Event Description

Additional information received from the physician.The patient is well without any problem.Recanalization was treated with stent-assisted coiling about 3 years ago.

• Brand Name: WEB SL
• Type of Device: INTRASACCULAR FLOW DISRUPTION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 12256998
• MDR Text Key: 264473630
• Report Number: 2032493-2021-00304
• Device Sequence Number: 1
• Product Code: OPR
• Combination Product (y/n): N
• PMA/PMN Number: P170032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 07/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 40 YR