BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC ANEURX STENT GRAFT SYSTEM

    MDR report key: 2884173 · Received December 21, 2012

    Report

    Report Number
    2953200-2012-02478
    Event Type
    Death
    Date Received
    December 21, 2012
    Date of Event
    November 25, 2012
    Report Date
    November 25, 2012
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (DEATH, ENDOLEAK, MIGRATION, ANEURYSM RUPTURE). PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (DISEASE PROGRESSION, DILATED AORTIC NECK). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (DISEASE PROGRESSION, DILATED AORTIC NECK).

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM OVER 10 YEARS AGO. ANEURYSM AND VESSEL MORPHOLOGY FROM THE TIME OF IMPLANT ARE UNKNOWN. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY WITH A RUPTURED ANEURYSM THAT HAD INCREASED IN DIAMETER TO 10CM APPROXIMATELY ONE MONTH AGO. THE PROXIMAL AORTIC NECK MEASURED 32-33 MM IN DIAMETER. A CT REVEALED STENT GRAFT MIGRATION OF NECK 4CM BELOW THE RENAL ARTERIES WITH A PROXIMAL TYPE I ENDOLEAK NOTED. THE STENT GRAFT MIGRATION AND ENDOLEAK WERE ATTRIBUTED TO DISEASE PROGRESSION. THE PATIENT ALSO HAD A RIGHT COMMON ILIAC ANEURYSM THAT WAS 5CM IN DIAMETER AND A LEFT COMMON ILIAC ANEURYSM THAT WAS 3.5 - 4 CM IN DIAMETER. THE PHYSICIAN REPAIRED THE MIGRATION AND ENDOLEAK WITH AN ENDURANT CUFF ETCF3232C49E, AN ETCF3636C49E AND AN ETCF3636C49E. THE ILIAC ANEURYSMS WERE TREATED WITH AN ETLW1616C124E AND AN ETLW1616C124E ON THE RIGHT AND AN ETLW1613C156E ON THE LEFT WHICH WAS THE CONTRALATERAL SIDE. THE PHYSICIAN BLOCKED OFF RIGHT BELOW THE FLOW DIVIDER AND PERFORMED A FEM-FEM BYPASS. THE PATIENT WAS ON A VENTILATOR. IT WAS REPORTED THAT THE PATIENT EXPIRED DUE TO HEART FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC ANEURX STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR M02F552177

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Death