BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT ILIAC STENT GRAFT

    MDR report key: 2152999 · Received June 17, 2011

    Report

    Report Number
    2953200-2011-01164
    Event Type
    Death
    Date Received
    June 17, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 20, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: (BLOOD LOSS, DEATH), (ANOTHER MFR'S SUTURE-MEDIATED CLOSURE SYSTEM), (BALLOONING OUTSIDE THE STENT GRAFT). CONCLUSIONS: (ANOTHER MFR'S SUTURE-MEDIATED CLOSURE SYSTEM), (BALLOONING OUTSIDE THE STENT GRAFT).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A 47.4 MM ABDOMINAL AORTIC ANEURYSM APPROX ONE MONTH AGO. VESSEL MORPHOLOGY WAS REPORTED AS THE AORTIC NECK WAS 14.5 MM LONG, 19.8-20.8 MM IN DIAMETER, AND MILDLY ANGULATED, MILDLY CALCIFIED, AND WITH MODERATE THROMBUS. THE ILIAC ARTERIES WERE 14.9 MM TO 18.9 MM IN DIAMETER ON THE RIGHT AND 8 MM TO 10 MM IN DIAMETER ON THE LEFT AND MILDLY TORTUOUS AND MILDLY CALCIFIED. ACCESS VESSELS WERE 8 MM IN DIAMETER ON THE RIGHT AND 9.45 MM IN DIAMETER ON THE LEFT AND MILDLY CALCIFIED. THE LEFT RENAL ARTERY HAD A PARTIAL DISSECTION. AN ENDURANT BIFURCATED STENT GRAFT SYSTEM (REF MFR 2953200-2011-00162 AND REF MFR 2953200-2011-01163) WAS IMPLANTED VIA A PERCUTANEOUS ACCESS. THERE WERE ACCESS ISSUES WITH ANOTHER MFR'S SUTURE-MEDIATED CLOSURE SYSTEM AT THE START OF THE CASE, WITH A LOT OF BLEEDING. MANUAL COMPRESSION WAS APPLIED BEFORE PROCEEDING WITH THE CASE. A SHEATH AND A FEMORAL-STOP WERE PLACED TO ENSURE A SEAL, AND THE BLEEDING WAS UNDER CONTROL BEFORE THE EVAR. THE STENT GRAFTS WERE IMPLANTED AND MODELED WITH A RELIANT BALLOON, (REF MFR 2953200-2011-01164), WITH THE BALLOON OUTSIDE OF THE GRAFT SLIGHTLY ON THE LEFT SIDE (IPSILATERAL). THE FINAL ANGIOGRAM SHOWED NO ENDOLEAKS AND GOOD PLACEMENT OF THE STENT GRAFTS. IT WAS REPORTED THAT THREE HRS LATER, THERE WAS INTERNAL BLEEDING, AND THERE WAS NO GROIN HOMEOSTASIS. THE SURGEON OPERATED, AND THERE WAS A LOT OF BLOOD FROM AN UNK LOCATION, MOST LIKELY THE LEFT ILIAC ARTERY. THERE WAS NO CT PERFORMED. THE PT LATER THAT NIGHT DEVELOPED ARDS (ADULT RESPIRATORY DISTRESS SYNDROME) AS A RESULT OF MASSIVE TRANSFUSION AND EXPIRED OF LUNG ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT ILIAC STENT GRAFT MIH MEDTRONIC IRELAND NA V00818195

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death| R