BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2133346 · Received June 14, 2011

    Report

    Report Number
    2953200-2011-01145
    Event Type
    Death
    Date Received
    June 14, 2011
    Date of Event
    May 15, 2011
    Report Date
    May 15, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: (DISSECTION, DEATH), (PRE-EXISTING RUPTURED ANEURYSM), (STENT GRAFT USED FOR TREATMENT OF PRE-EXISTING RUPTURED ANEURYSM). CONCLUSION: (PRE-EXISTING RUPTURED ANEURYSM), (STENT GRAFT USED FOR TREATMENT OF A PRE-EXISTING RUPTURED ANEURYSM).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE EMERGENT ENDOVASCULAR TREATMENT OF A RUPTURED 10 CM ABDOMINAL AORTIC ANEURYSM APPROX ONE MONTH AGO. VESSEL MORPHOLOGY WAS REPORTED AS AORTIC NECK WAS 21MM TO 27 MM IN DIAMETER AND 10 MM LONG. IT WAS REPORTED THAT ANOTHER MFR'S BALLOON WAS PLACED SUPRARENAL TO OCCLUDE AORTIC BLOOD FLOW, AND THE RENAL ARTERIES WERE CLAMPED OFF. THE PT WAS RECEIVING RESUSCITATION EFFORTS WITH CPR PRIOR TO STENT GRAFT IMPLANT, FOR AN UNK PERIOD OF TIME. THE PHYSICIAN DECIDED TO TRY EVAR. A RELIANT BALLOON WAS ALSO PLACED TO TRY TO OCCLUDE BLOOD FLOW. AN ENDURANT BIFURCATED STENT GRAFT (REF MFR# 2953200-2011-01142) AND ENDURANT IPSILATERAL EXTENSION (REF MFR# 2953200-2011-01143) WERE PLACED ON THE LEFT SIDE, AND AN ANEURX CONTRALATERAL LIMB (REF MFR# 2953200-2011-01145) AND CONTRALATERAL EXTENSION (REF MFR# 2953200-2011-01146) WERE PLACED VIA THE RIGHT SIDE. THE STENT GRAFTS WERE PLACED W/O ISSUES; HOWEVER, THERE WAS TOO MUCH BLOOD LOSS, AND THE PT'S BLOOD WAS PRESSING ON THE LUNGS, DIAPHRAGM, AND VENA CAVA. THERE WAS NO VENOUS RETURN, AND THE PT WAS BECOMING ACIDOTIC AND COULD NOT BREATHE EVEN WITH THE VENTILATOR. RESCUE EFFORTS INCLUDED OPENING THE PT'S ABDOMEN AND USING A RAPID BLOOD INFUSER; HOWEVER, THE PT'S CONDITION WAS WORSENING, AND THE PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC IRELAND NA V00797250

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death