BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT AAA

    MDR report key: 3677680 · Received March 13, 2014

    Report

    Report Number
    2953200-2014-00488
    Event Type
    Death
    Date Received
    March 13, 2014
    Date of Event
    January 3, 2013
    Report Date
    February 17, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, CONCLUSION: OFF-LABEL (SEVERELY ANGULATED AORTIC NECK 135 DEGREE).

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS OBTAINED FROM A JOURNAL ARTICLE. LATE EVENTS AND MID-TERM RESULTS AFTER ENDOVASCULAR ANEURYSM REPAIR. H. ISHIBASHI, T. ISHIGUCHI, T. OHTA, I. SUGIMOTO, H. IWATA, T. YAMADA, M. TADAKOSHI, N. HIDA, Y. ORIMOTO (SURG TODAY (2014) 44:50¿54) THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: DEATH, POSITIONING DIFFICULTIES, PERFORATION, CEREBRAL INFRACTION, POST-OP DISSECTION, TYPE I AND III ENDOLEAKS, GRAFT MIGRATION, LIMB OCCLUSION, GRAFT INFECTION, OPEN CONVERSION. NO FURTHER INFORMATION IS AVAILABLE FOR THIS EVENT. PURPOSE TO EVALUATE THE LATE EVENTS AND MID-TERM RESULTS AFTER ENDOVASCULAR ANEURYSM REPAIR (EVAR). METHODS BETWEEN DECEMBER 2006 AND MAY 2012, 175 ABDOMINAL AORTIC ANEURYSMS WERE TREATED BY EVAR. ANEURYSM-RELATED EVENTS WERE ANALYZED. RESULTS THE COMPLICATIONS THAT OCCURRED DURING THE EVAR PROCEDURE WERE RENAL ARTERY OCCLUSION IN TWO PATIENTS, ACCESS ARTERY INJURY IN TWO, DELIVERY FAILURE IN ONE, RETROGRADE AORTIC DISSECTION IN ONE, AND DEATH FROM HEPATIC FAILURE IN ONE PATIENT. FIVE ADVERSE ENDOLEAKS (FOUR TYPE I, ONE TYPE III) REMAINED AT DISCHARGE, AND THE TECHNICAL SUCCESS RATE WAS 97 %. ON FOLLOW-UP, LIMB OCCLUSION HAD OCCURRED IN FIVE PATIENTS. UNILATERAL RENAL ATROPHY WAS FOUND IN THREE PATIENTS, BUT NONE OF THE PATIENTS REQUIRED NEW HEMODIALYSIS. SAC ENLARGEMENT (C5 MM) DEVELOPED IN TEN PATIENTS. THEIR CULPRIT ENDOLEAKS WERE TYPE IA IN ONE, II IN EIGHT, AND V IN ONE PATIENT. TRANSARTERIAL EMBOLIZATION WAS PERFORMED FOR THREE OUT OF THE EIGHT TYPE II ENDOLEAKS. THE RATE OF FREEDOM FROM SECONDARY RE-INTERVENTION WAS 93 % AT 3 AND 5 YEARS, RESPECTIVELY. THE SURVIVAL AND FREEDOM FROM ANEURYSM-RELATED EVENTS RATES WERE 74 % AT 3 YEARS AND 47 % AT 5 YEARS. CONCLUSIONS THE MID-TERM RESULTS OF EVAR WERE EXCELLENT WITH A LOW RATE OF ANEURYSM-RELATED DEATHS, ALTHOUGH THERE WERE RELATIVELY HIGH ANEURYSM-RELATED EVENT RATES. SAC RE-ENLARGEMENT FROM TYPE II ENDOLEAKS WAS THE MOST COMMON MAJOR ISSUE AT THE MID-TERM FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149786 TALENT AAA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Death