BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 1364979 · Received April 15, 2009

    Report

    Report Number
    2953200-2009-00460
    Event Type
    Death
    Date Received
    April 15, 2009
    Date of Event
    March 1, 2009
    Report Date
    March 23, 2009
    Manufacturer
    MEDTRONIC VASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: RESULTS AND CONCLUSION: (DEATH, ENDOLEAK), (JOURNAL EVENT RELATIONSHIP TO DEVICE UNK). THE AUTHOR HAS BEEN CONTACTED. PT AND DEVICE SPEC REGARDING THE EVENTS IN THE JOURNAL ARTICLE INFO HAVE BEEN RECEIVED AT TIME OF THIS REPORT. THE JOURNAL ARTICLE IS REFERENCED AS ANN SURG 2009;249: 510-515.

    Description of Event or Problem · 1

    MEDTRONIC CARDIOVASCULAR HAS RECEIVED A JOURNAL ARTICLE ENTITLED "10 YEARS OF EMERGENCY ENDOVASCULAR ANEURYSM REPAIR FOR RUPTURED ABDOMINAL AORTOILIAC ANEURYSM: LESSONS LEARNED (ANN SURG 2009;249: 510-515)". THE MANUSCRIPT IS BASED ON A STUDY IN ANOTHER COUNTRY, THAT EVALUATED EMERGENCY ENDOVASCULAR ANEURYSM REPAIR IN PTS WITH RUPTURED ABDOMINAL AORTIC ANEURYSM. THE STUDY RAN FROM JAN 1998 TO APRIL 2008. ABOUT 102 PTS TREATED BY EVAR FOR A RUPTURED AAA INCLUDING COOK, GORE & TALENT AAA DEVICES. THE TALENT AAA STENT GRAFT WAS IMPLANTED IN 3 PTS. THERE WAS NO DISTINCTION IN THE DEVICE TO EVENT RELATIONSHIP. THE MEAN AGE WAS 73+-9 WITH PROPORTION OF MALE TO FEMALE. THE FOLLOWING ADVERSE EVENTS WERE REPORTED WITH ALL DEVICES: 16 TYPE I ENDOLEAKS; 10 PTS RETURNED TO OR FOR EARLY SEALING, 26 TYPE II ENDOLEAKS; 2 PTS RETURNED TO THE OR FOR EARLY SEALING, 1 TYPE IIIA ENDOLEAK. THIRTEEN PTS DIED WITHIN 30-DAYS WHICH INCLUDE: 1 SUICIDE, 1 LIVER FAILURE, 1 BLEEDING (RE-RUPTURE), 1 SUDDEN DEATH (VF), 1 PNEUMONIA, 1 BLEEDING (AFTER AOT), 4MOF, 1 BLEEDING, 2 ACUTE MI. MAJOR 30-DAY MORBIDITY INCLUDED: 1 SEALING, TECHNICAL PROBLEM, 1 ACUTE LIMB THROMBOSIS, 1 PARTIAL LIMB THROMBOSIS, 1 LIMB DISLOCATION, 1 ASPIRATION DURING INTUBATION WITH SEPTIC SHOCK, 20 ABDOMINAL COMPARTMENT SYNDROME, 1 INFERIOR VENA CAVA THROMBOSIS, 1 ACUTE MI, 1 VENTRICULAR TACHYCARDIA, 1 PNEUMONIA, 1 RENAL INFARCTION, 1 GASTRODUODENAL BLEEDING, 1 ACUTE LIMB ISCHEMIA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death