MAUDE Adverse Event Report: MICROVENTION, INC. FRED 21; FLOW DIVERTER

Model Number FRED3009-PMA

Device Problem Unintended Movement (3026)

Patient Problem Ischemia Stroke (4418)

Event Date 05/25/2021

Event Type  Injury  

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 implanted in the patient and is not available for return to the manufacturer for analysis; therefore, the alleged product issue cannot be confirmed.The instructions for use (ifu) identifies stroke or tia (transient ischemic attack), migration or misplacement as potential complications associated with use of the device.

Event Description

It was reported that after successfully implanting the fred 21 stent in the m1 segment of middle cerebral artery (mca) aneurysm, the patient came back 6 days post implantation with a stroke.Angiogram run showed the stent migrated down the m1 vessel blocking the bifurcation.Intervention was taken and the patient was treated with direct catheter integrilin and drip.

• Brand Name: FRED 21
• 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: 12097221
• MDR Text Key: 259383911
• Report Number: 2032493-2021-00262
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00842429106617
• UDI-Public: (01)00842429106617(11)200311(17)230228(10)20031153X
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P180027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/01/2021

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 Expiration Date: 02/28/2023
• Device Model Number: FRED3009-PMA
• Device Lot Number: 20031153X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/01/2021
• Initial Date FDA Received: 06/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2020
• 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