BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO

    MDR report key: 1741718 · Received June 28, 2010

    Report

    Report Number
    2953200-2010-01228
    Event Type
    Death
    Date Received
    June 28, 2010
    Date of Event
    May 29, 2010
    Report Date
    May 29, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). EVALUATION RESULTS AND CONCLUSION: DEATH; SHORT ANGULATED AORTIC NECK, LARGE PRE-OPERATIVELY RUPTURED ANEURYSM.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE EMERGENT ENDOVASCULAR TREATMENT OF A PRE-OPERATIVELY RUPTURED 11 CM ABDOMINAL AORTIC ANEURYSM. THE AORTIC NECK HAD SEVERE ANGULATION OF GREATER THAN 70 DEGREES, ITS DIAMETER AT THE RENAL ARTERIES WAS 29 MM, 10 MM BELOW THE RENAL ARTERIES, IT WAS 30 MM. PT WAS SEVERELY OBESE WHICH RESULTED IN IMAGING DIFFICULTY. THE VESSELS WERE MODERATELY TORTUOUS AND MILDLY CALCIFIED. IT WAS REPORTED THAT AFTER THE BIFURCATED STENT WAS IMPLANTED THERE WAS DIFFICULTY IN CANNULATING THE CONTRALATERAL GATE. AT THIS TIME IT WAS NOTED THAT THE PT'S AORTA WAS LONGER IN LENGTH THAN WHAT WAS MEASURED/APPEARED ON THE CT SCAN. THE IPSILATERAL LIMB OF THE BIFURCATED STENT GRAFT WAS BARELY TOUCHING THE ORIGIN OF THE RIGHT ILIAC ARTERY. THE PHYSICIAN WAS THEN ABLE TO CANNULATE THE GATE, SPUN THE PIGTAIL CATHETER AND IT APPEARED FINE AND IMPLANTED THE ILIAC LIMB. IT WAS NOTED THAT THE CONTRALATERAL LIMB WAS IMPLANTED IN THE IPSILATERAL SIDE OF THE BIFURCATED STENT GRAFTS. THE DECISION WAS MADE TO CONVERT TO AN OPEN REPAIR AND EXPLANTED THE STENT GRAFTS. AFTER THE CONVERSION THE PT WAS STABLE; HOWEVER, THE PT EXPIRED 2 DAYS LATER (SEE MFR 2953200-2010-01227). THE PHYSICIAN STATED THAT THE PT HAD LOST A LARGE AMOUNT OF BLOOD DUE TO THE PRE-OPERATIVELY RUPTURED 11 CM ANEURYSM AND WAS UNABLE TO RECOVER, EVEN THOUGH BLOOD PRODUCTS WERE GIVEN. THE EXPLANTED STENT GRAFTS WERE DISCARDED. NO FURTHER INFO HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO MIH MEDTRONIC CARDIOVASCULAR NA V00253704

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death