BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM

    MDR report key: 2093523 · Received April 29, 2011

    Report

    Report Number
    2953200-2011-00919
    Event Type
    Death
    Date Received
    April 29, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 1, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: DEATH, ENDOLEAK AND ARTERIAL OCCLUSION. ELEPHANT TRUNK AND TORTUOUS AORTA. EVALUATION, CONCLUSIONS: ELEPHANT TRUNK AND TORTUOUS AORTA.

    Description of Event or Problem · 1

    A TALENT THORACIC STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A 6.8 CM ELEPHANT TRUNK, 30 MM DIAMETER ASCENDING AORTA WITH A SURGICAL TUBE GRAFT PLACED APPROXIMATELY ONE WEEK PRIOR TO THE TEVAR. THE TALENT STENT GRAFTS WERE IMPLANTED APPROXIMATELY ONE MONTH AGO. THE AORTA WAS MODERATELY TORTUOUS AND WAS 38-43 MM IN DIAMETER PROXIMAL TO THE THORACIC ANEURYSM AND 40-43 MM IN DIAMETER ABOVE THE CELIAC ARTERY. THERE WAS NO THROMBUS/CALCIFICATION PROXIMAL TO THE TAA BUT MILD THROMBUS/CALCIFICATION DISTAL TO THE TAA. THE PT HAD A SPINAL DRAIN PLACED. IT WAS REPORTED THAT FIRST TALENT CAPTIVA WAS PLACED PROXIMALLY, OVERLAPPING THE SURGICAL TUBE GRAFT. A SECOND TALENT STENT GRAFT WAS PLACED NEXT, FOLLOWED BY A THIRD TALENT CAPTIVA STENT GRAFT MOST DISTALLY, WHICH HAD AN INTENDED LANDING ZONE 2.5 CM ABOVE THE CELIAC. THE STENT GRAFT PLACEMENT LOOKED FINE, AND THE STENT GRAFTS WERE BALLOONED NORMALLY (NON-AGGRESSIVELY) WITH A RELIANT BALLOON. A PIGTAIL CATHETER WAS INSERTED AGAIN TO OBTAIN AN ANGIOGRAM; HOWEVER, IT COULD NOT BE ADVANCED PAST THE ABDOMEN. IMAGING REVEALED THAT THE DISTAL STENT GRAFT HAD DISLODGED FROM THE MIDDLE STENT GRAFT AND SLIPPED ALL THE WAY TO THE ABDOMEN COVERING THE CELIAC, SMA, AND RENAL ARTERIES WITH A JUNCTIONAL TYPE III ENDOLEAK BETWEEN THE MIDDLE AND DISTAL STENT GRAFTS. AN OPEN REPAIR OF THE ABDOMEN WAS PERFORMED TO EXPLANT THE DISTAL GRAFT AND REPAIR THE ENDOLEAK AND UNCOVER THE VESSELS. AS THE AORTA WAS QUITE FRIABLE, TOO MUCH BLOOD WAS LOST IN THE REPAIR ATTEMPT, AND THE PT EXPIRED (REF MFR# 2953200-2011-00918, 2953200-2011-00920).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT THORACIC STENT GRAFT SYSTEM MIH MEDTRONIC IRELAND NA V00537844

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death