BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC ANEURX BIFURCATED STENT GRAFT (UNK)

    MDR report key: 336331 · Received June 7, 2001

    Report

    Report Number
    2953738-2001-00109
    Event Type
    Injury
    Date Received
    June 7, 2001
    Report Date
    April 6, 2001
    Manufacturer
    MEDTRONIC AVE PERIPHERAL DIVISION
    Product Code
    MIH
    Removal / Correction Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AN ANEURX BIFURCATED STENT GRAFT AND ITS COMPONENTS OF UNKNOWN SIZE WERE IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM ON AN UNKNOWN DATE. ANEURYSM SIZING AND VESSEL MORPHOLOGY IS UNKNOWN. IT WAS REPORTED THAT THERE WAS PROXIMAL MIGRATION OF THE STENT GRAFT, DISLOCATION OF TWO SEPARATE STENT CUFFS, AND A 5MM INCREASE IN THE ANEURYSM SAC SIZE. IT IS REPORTED THAT THERE IS A PLAN TO INSERT A FULL STENT GRAFT THROUGH THE LUMEN TO LOCATE ABOVE THE INDWELLING DEVICE (A GORE EXCLUDER). THE DATE OF THIS PROCEDURE IS UNKNOWN. THE PATIENT'S STATUS IS UNKNOWN. FURTHER INFORMATION FROM THE USER FACILITY IS PENDING AT THIS TIME.

    Description of Event or Problem · 1

    ADDITIONAL INFO RECEIVED BY MEDTRONIC AVE HAS CONFIRMED THAT MFR REPORT NUMBER 2952368-2002-00051 IS THE SAME PT AS MFR REPORT NUMBER 2953738-2001-00109.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26334 MEDTRONIC ANEURX BIFURCATED STENT GRAFT (UNK) AAA STENT GRAFT MIH MEDTRONIC AVE PERIPHERAL DIVISION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention