BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT AAA STENT GRAFT

    MDR report key: 2535166 · Received April 13, 2012

    Report

    Report Number
    2953200-2012-00774
    Event Type
    Death
    Date Received
    April 13, 2012
    Report Date
    March 19, 2012
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (DEATH, ENDOLEAK, RUPTURE), PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (ANATOMY RELATED). EVALUATION CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (ANATOMY RELATED).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE J VASC SURG 2012, WHICH IS SUMMARIZED AS FOLLOWS. WOMEN DERIVE LESS BENEFIT FROM ELECTIVE ENDOVASCULAR ANEURYSM REPAIR THAN MEN, MEHTA ET AL. THE MEDTRONIC STENTS USED IN THIS STUDY WERE ANEURX AND TALENT. ALL EVARS WERE PERFORMED BY SURGICAL EXPOSURE OF THE COMMON FEMORAL OR DISTAL EXTERNAL ILIAC ARTERIES. FOR WOMEN, ELECTIVE EVAR RESULTED IN SIGNIFICANTLY GREATER MORTALITY RATES THAN MEN (3.2% VS 0.96%, P=.005). THERE WAS A GREATER INCIDENCE OF INTRAOPERATIVE AORTIC NECK, OR ILIAC ARTERY RUPTURE (4.1% VS 1.2% P= 0.002) AND PALMAZ STENT PLACEMENT FOR TYPE 1 ENDOLEAKS (16.1% VS 8%, P=0.0009). PERIOPERATIVE COMPLICATIONS WERE ALSO MORE FREQUENT IN WOMEN: LEG ISCHEMIA (3.5% VS 0.6%, P=0.003) AND COLON ISCHEMIA REQUIRING COLECTOMY (0.9% VS 0.2%, P=0.009). THE CAUSES OF DEATH (N=11) WERE AORTIC NECK RUPTURE (N=2), ILIAC ARTERY RUPTURE (N=4), COLON ISCHEMIA (N=1), AND MULTISYSTEM ORGAN FAILURE (N=4). COLON ISCHEMIA, NATIVE ARTERIAL RUPTURE, AND TYPE 1 ENDOLEAKS ARE MORE FREQUENT. ONE THOUSAND SIX HUNDRED NINETY EIGHT EVAR PROCEDURES DONE FROM 2002-2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT AAA STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention