BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT STENT GRAFT WITH XCELERANT - HYDRO

    MDR report key: 1982465 · Received February 3, 2011

    Report

    Report Number
    2953200-2011-00259
    Event Type
    Death
    Date Received
    February 3, 2011
    Date of Event
    January 4, 2011
    Report Date
    January 4, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL RESULTS: (DEATH, RUPTURED ANEURYSM, ENDOLEAK), (SEVERELY TORTUOUS VESSELS, TYPE 2 ENDOLEAK). CONCLUSIONS: (SEVERELY TORTUOUS VESSELS, TYPE 2 ENDOLEAK).

    Description of Event or Problem · 1

    A TALENT BIFURCATED STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR EMERGENT ENDOVASCULAR TREATMENT OF A PRE-OPERATIVE RUPTURED 11 CM ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY WAS REPORTED AS SEVERELY TORTUOUS. THE BIFURCATED STENT GRAFT WAS SUCCESSFULLY IMPLANTED. IT WAS REPORTED THAT AFTER THE CONTRALATERAL LIMB AND THE CONTRA EXTENSION STENT GRAFT WERE IMPLANTED THERE WAS A TYPE 3 ENDOLEAK BETWEEN THEM (MFR 2953200-2011-00255, 2953200-2011-00256) WHICH WAS FILLING THE SAC. AN ILIAC EXTENSION WAS IMPLANTED BRIDGING THE TWO STENT GRAFTS. (MFR 2953200-2011-00257) THE PHYSICIAN IMPLANTED THREE ADD'L ILIAC EXTENSION LIMBS. (MFR 2953200-2011-00258, 2953200-2011-00260) THE PT HAD ACTIVE BLEEDING FROM A LARGE LUMBAR ARTERY, TYPE II ENDOLEAK. THE PT'S ABDOMEN WAS OPENED (MID-LINE INCISION) IN ORDER TO EVACUATE BLOOD FROM THE RUPTURED ANEURYSM AND THE BLEEDING LUMBAR ARTERY. THIS PROCEDURE WAS NOT RELATED TO THE STENT GRAFT. THE PT EXPIRED LATER THAT SAME DAY. THE PHYSICIAN STATED THAT THE PT'S DEATH WAS DUE TO THE RUPTURED ANEURYSM AND BLEEDING FROM THE LUMBAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT STENT GRAFT WITH XCELERANT - HYDRO MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00790715

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death