BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM -HYDRO

    MDR report key: 1941969 · Received December 23, 2010

    Report

    Report Number
    2953200-2010-02639
    Event Type
    Death
    Date Received
    December 23, 2010
    Date of Event
    December 2, 2010
    Report Date
    December 2, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL RESULTS: (DEATH).

    Description of Event or Problem · 1

    A MEDTRONIC STENT GRAFT SYSTEM WHICH IS NOT APPROVED IN THE U.S., WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2010. ONE OF THE STENT GRAFT COMPONENTS, A TALENT ILIAC LIMB STENT GRAFT WAS ALSO USED IN THIS PROCEDURE. VESSEL MORPHOLOGY WAS NOT REPORTED. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED WITHOUT ANY TECHNICAL ISSUE. THERE WAS AN INTRA-OPERATIVE TYPE 1 ENDOLEAK WHICH WAS REPAIRED WITH AN AORTIC CUFF AND THE ENDOLEAK WAS RESOLVED (BOTH THE BIFURCATED STENT GRAFT AND THE AORTIC CUFF ARE NOT APPROVED IN THE U.S.). THE PT WAS RELEASED. THE PT WAS RE-ADMITTED TO THE HOSPITAL AT AN UNK DATE WITH ABDOMINAL PAIN. A BOWEL INFARCT PROBABLY CAUSED BY A COMPLETE THROMBOSIS OF THE SUPERIOR MESENTERIC ARTERY RESULTED IN THE RE-HOSPITALIZATION OF THE PT (THIS IS RELATED TO ONE OF THE STENT GRAFTS THAT ARE NOT APPROVED IN THE U.S.). THE PHYSICIAN CANNOT CONCLUSIVELY DETERMINE AND DOES NOT HAVE A CLEAR IDEA OF WHAT CAUSED THE THROMBOSIS OF THE SUPERIOR MESENTERIC ARTERY. IT WAS NOTED THAT IT IS POSSIBLE THAT THE PRESENCE OF MULTIPLE FREE FLOW STRUTS OF THE BIFURCATED STENT GRAFT AND THE AORTIC EXTENSION (DEVICES ARE NOT APPROVED IN THE U.S.), WERE OVER THE OSTIUM OF THE SUPERIOR MESENTERIC ARTERY. THE PT SUBSEQUENTLY EXPIRED ON (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL STENT GRAFT SYSTEM -HYDRO MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00416570

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death