BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC ANEURX BIFURCATED STENT GRAFT (FLEXIBLE)

    MDR report key: 640540 · Received September 12, 2005

    Report

    Report Number
    2953200-2005-01302
    Event Type
    Injury
    Date Received
    September 12, 2005
    Date of Event
    September 12, 2005
    Report Date
    September 12, 2005
    Manufacturer
    MEDTRONIC VASCULAR
    Product Code
    MIH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AN UNKNOWN LENGTH ANEURX BIFURCATED STENT GRAFT AND ITS COMPONENTS WERE IMPLANTED INTO A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM MORPHOLOGY AT THE TIME OF IMPLANT IS UNKNOWN. IT WAS REPORTED THAT THE ANEURYSM HAS ENLARGED TO 28MM FROM 25MM AND THAT THE STENT GRAFT HAS MIGRATED 12 MM DISTALLY. POST STENT GRAFT IMPLANTATION A REQUEST FOR A TALENT AORTIC CUFF UNDER IDE (G020050) WAS REQUESTED. THE PHYSICIAN REQUESTED INFORMATION DUE TO DISTAL MIGRATION AND COMPROMISED SEAL ZONE. PER MEDTRONIC TALENT AORTIC CUFF APPROVED PROTOCOL, MEDTRONIC SENT THE SITE THE DOCUMENTATION REQUIRED FOR EACH REQUEST TO COMPLETE FOR APPROVAL FOR THE TALENT AORTIC CUFF TRIAL. HOWEVER, THE REQUESTER DID NOT RETURN THE REQUIRED DOCUMENTATION; THEREFORE NO TALENT AORTIC CUFF TRIAL DEVICE WAS SENT. THERE WAS NO FURTHER INFORMATION PROVIDED TO MEDTRONIC ABOUT THE REQUEST FOR THE DEVICE OR THE DETAILS OF THE PATIENT RELATING TO THE ANEURX DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC ANEURX BIFURCATED STENT GRAFT (FLEXIBLE) AAA STENT GRAFT MIH MEDTRONIC VASCULAR NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention