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

Model Number UNKNOWN

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

Patient Problems Ischemia Stroke (4418); Ruptured Aneurysm (4436)

Event Type  Death  

Manufacturer Narrative

The lot number was not provided; therefore, a search for production-related ncrs could not be performed.The device was implanted in the patient and thus could not be returned to the manufacturer for evaluation.Attempts are being made to obtain additional information about the events and devices.If further information is received, a supplemental report will be submitted.The instructions for use (ifu) identifies aneurysm perforation or rupture, ischemic stroke, and death as potential complications associated with use of the device.

Event Description

As reported in the article titled, "stent-assisted web embolization: aneurysm characteristics, outcome and case report of a web delivered through a stent" published in acta neurochirurgica, the company became aware of the results of a retrospective, multi-center analysis comparing the safety profile of stent-assisted web embolization with the safety profile of web alone.In the discussion of data regarding complications, it was reported that two patients suffered neurological complications ischemic stroke and procedural aneurysm rupture in the web only group which led to their deaths.

• 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: 13588947
• MDR Text Key: 286041677
• Report Number: 2032493-2022-00066
• Device Sequence Number: 1
• Product Code: OPR
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P170032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2022
• 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): Death