MAUDE Adverse Event Report: MICROVENTION, INC. FRED JR. FLOW DIVERTER

Model Number FREDJR2520

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

Patient Problems Stroke/CVA (1770); Paralysis (1997); Speech Disorder (4415); Thrombosis/Thrombus (4440)

Event Date 11/24/2021

Event Type  Injury  

Event Description

It was reported that a fred jr. Stent was implanted to treat an aneurysm of the left mca. After the procedure, in-stent thrombosis formed. A thrombectomy was performed and the stent was removed. The patient experienced a stroke (nihss score: 20) on the ipsilateral side and has permanent damage. Following stent removal, angiography showed arterial unclogging but with the presence of multiple distal occlusions. The patient was hospitalized. Their clinical status was stable with aphasia, deviation and right-side hemiplegia.

Manufacturer Narrative

A search for non-conformances associated with the reported 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 not returned to the manufacturer for evaluation. Procedural or post procedural images were not provided; therefore the reported event could not be confirmed. The instructions for use (ifu) identifies in-stent thrombosis as a potential complication associated with use of the device.

• Brand Name: FRED JR.
• Type of Device: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 13056755
• MDR Text Key: 284209494
• Report Number: 2032493-2021-00509
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P180027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative

Reporter Occupation

• Type of Report: Initial
• Report Date: 11/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: FREDJR2520
• Device Lot Number: 210113521
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 12/21/2021 Patient Sequence Number: 1