MAUDE Adverse Event Report: MICROVENTION, INC. FRED X27; FLOW DIVERTER

Model Number XFRED4508-MVE

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

Patient Problems Paresis (1998); Speech Disorder (4415)

Event Date 01/12/2022

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.The instructions for use (ifu) identifies aphasia as a potential complication associated with the use of the device.

Event Description

It was reported through the frits study that post implantation of a fred x27 stent, the subject developed paresis of right hand and aphasia.The deficit was trnsient.Medications were administered and the event outcome resolved the next day without sequelae.

• Brand Name: FRED X27
• 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: 13544605
• MDR Text Key: 289004447
• Report Number: 2032493-2022-00060
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00842429107539
• UDI-Public: (01)00842429107539(11)210202(17)240131(10)21020212Y
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P180027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/20/2022

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: XFRED4508-MVE
• Device Lot Number: 21020212Y
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/20/2022
• Initial Date FDA Received: 02/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2021
• 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
• Patient Age: 76 YR
• Patient Sex: Female