BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC ANEURX STENT GRAFT SYSTEM

    MDR report key: 1545935 · Received November 24, 2009

    Report

    Report Number
    2953200-2009-01691
    Event Type
    Death
    Date Received
    November 24, 2009
    Date of Event
    October 31, 2009
    Report Date
    October 31, 2009
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: (DEATH, ENDOLEAK, RUPTURE). (AORTIC NECK IS SEVERELY CALCIFIED, ANGULATED 80 DEGREES, AND REVERSE FUNNEL SHAPED WITH A DIAMETER OF 29-34 MM).

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS SUCCESSFULLY IMPLANTED INTO A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 88 MONTHS AGO. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WERE NOT REPORTED AND THE PT'S FOLLOW-UP HISTORY IS UNK, BUT THOUGHT TO BE NONE OR LIMITED. IT WAS REPORTED APPROXIMATELY ONE TO TWO WEEKS BEFORE THE PLANNED INTERVENTION, THE PT PRESENTED EMERGENTLY WITH PAIN. THE PT HAD TRAVELED FROM OUT-OF-STATE BACK TO THE IMPLANTING HOSPITAL. THE PT HAS A 14 CM ANEURYSM WITH A CONTAINED RUPTURE AND A PROXIMAL TYPE 1 ENDOLEAK. AT THE TIME OF INTERVENTION, THE AORTIC NECK IS SEVERELY CALCIFIED, ANGULATED 80 DEGREES, AND REVERSE FUNNEL SHAPED WITH A DIAMETER OF 29-34 MM OVER A LENGTH OR 1.5-2 CM. THE ILIAC VESSELS ARE MODERATELY TORTUOUS AND MODERATELY CALCIFIED. DUE TO THE ILIAC TORTUOSITY, ONE OF THE ILIAC EXTENSION GRAFTS (MFR REPORT# 2952300-2009-001689) ON THE LEFT SIDE WAS KINKED AND DISLODGED, ALTHOUGH THERE WAS NO LOSS OF SEALS. A TYPE III ENDOLEAK WAS PRESENT BETWEEN THE BIFURCATED STENT GRAFTS. (MFR REPORT #2952300-2009-01690) AND THE AORTIC CUFF (MFR REPORT #2952300-2009-01691). A TALENT CUFF (MFR REPORT #2952300-2009-01692) WAS IMPLANTED BETWEEN THE ORIGINAL AORTIC CUFF AND BIFURCATED STENT GRAFT TO ATTEMPT TO RESOLVE THE TYPE III LEAK AND POSSIBLY THE TYPE I LEAK; HOWEVER, IT WAS INEFFECTIVE AT RESOLVING BOTH ENDOLEAKS. IT WAS THEN DECIDED TO IMPLANT ANOTHER MFR'S AORTIC CUFF IN THE TALENT CUFF USED TO INTERVENE FOR THE ENDOLEAKS AND TO CONVERT TO AN AUI BY IMPLANTING ANOTHER MFR'S CONVERTER AND 2 ANEURX ILIAC LIMBS (BOTH ON THE SAME SIDE) TO SUPPORT THE KINKED ANEURX LIMB. THESE ANEURX LIMBS WERE SUCCESSFULLY IMPLANTED: HOWEVER, A FEM-FEM BYPASS WAS NOT DONE. AFTER AN ANGIOGRAM WAS PERFORMED, THERE WAS STILL A PERSISTENT TYPE I ENDOLEAK, SO THE PHYSICIAN IMPLANTED ANOTHER PROXIMAL TALENT CUFF (MFR REPORT #2952300-2009-01693) AND INTENTIONALLY COVERED BOTH RENALS TO TRY TO RESOLVE THE PROXIMAL TYPE I ENDOLEAK (INTENDING FOR THE PT TO BE ON DIALYSIS, WHICH WOULD HAVE BEEN BETTER THAN NOT TREATING THE RUPTURE/LEAK). HOWEVER, THE TALENT CUFF WOULD NOT SEAL AND WAS NOT RESOLVING THE TYPE I ENDOLEAK, AND THE RENALS WERE STILL PATENT. IT WAS THEN DECIDED TO PERFORM AN OPEN SURGICAL CONVERSION, AND EXPLANT ALL THE STENT GRAFTS. A DACRON GRAFT WAS SEWN IN. THE PT WAS ALIVE AT THE END OF THE CASE. IT WAS REPORTED THE PT EXPIRED FROM SEVERE BLOOD LOSS LATER THAT NIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC ANEURX STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA M02D551935

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death