BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC ANEURX EXTENDER CUFF STENT GRAFT

    MDR report key: 359904 · Received November 13, 2001

    Report

    Report Number
    2953738-2001-00297
    Event Type
    Death
    Date Received
    November 13, 2001
    Date of Event
    October 2, 2001
    Manufacturer
    MEDTRONIC AVE PERIPHERAL DIVISION
    Product Code
    MIH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FURTHER INVESTIGATION BY MEDTRONIC AVE REVEALS THAT THE EVENT REFERENCED IN MFR# 2953738-2001-00297 IS THE SAME EVENT REFERENCED IN MFR REPORT# 953738-2001-00281.

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT OF UNKNOWN SIZE WAS IMPLANTED IN A PT FOR ENDOVASCULAR TREATMENT OF ABDOMINAL AORTIC ANEURYSM ON AN UNKNOWN DATE. ANEURYSM SIZE WAS REPORTED TO BE 8.2CM IN DIAMETER WITH AN AORTIC NECK SIZE OF 26MM. THE PT WAS REPORTED TO BE A HIGH-RISK CANDIDATE FOR AN OPEN PROCEDURE DUE TO THEIR AGE AND THEIR CORONARY ARTERY DISEASE. THE INITIAL RESULT AFTER IMPLANT WAS REPORTED TO BE "EXCELLENT" WITH ABDOMINAL AORTIC ANEURYSM EXCLUSION. IT WAS REPORTED THAT THERE WAS PROXIMAL MIGRATION OF THE ANEURX STENT GRAFT FOUND ON A FOLLOW-UP CT SCAN, AND THAT THE PT WAS AT HIGH RISK FOR RUPTURE OF THE ANEURYSM SHOULD PT DEVELOP AN ENDOLEAK. IN 2001, THE PT'S PHYSICIAN REQUESTED A TALENT AORTIC CUFF, AND THE IMPLANT OF THE DEVICE WAS REPORTEDLY SCHEDULED 2 MONTHS LATER. IT WAS REPORTED THAT THE PT DIED ON THE EVENT DATE OF UNKNOWN CAUSES. NO OTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51377 MEDTRONIC ANEURX EXTENDER CUFF STENT GRAFT AAA STENT GRAFT MIH MEDTRONIC AVE PERIPHERAL DIVISION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death