BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT AUI STENT GRAFT SYSTEM

    MDR report key: 2716018 · Received August 27, 2012

    Report

    Report Number
    2953200-2012-01636
    Event Type
    Death
    Date Received
    August 27, 2012
    Report Date
    August 3, 2012
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION CODES, RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK, OPEN SURGICAL REPAIR, PNEUMONIA, CARDIAC ISCHEMIA, INFECTION, DEATH) PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (PRE-OPERATIVE RUPTURE, TYPE II ENDOLEAK) EVALUATION CODES, CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (PRE-OPERATIVE RUPTURE, TYPE II ENDOLEAK).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED: EMERGENCY ENDOVASCULAR ANEURYSM REPAIR FOR RUPTURED ABDOMINAL AORTIC ANEURYSMS: AN INSTITUTIONAL EXPERIENCE, S. DELALIEUX, ACTA CHIR BELG, 2010, 110, 272-274. ON AN UNKNOWN DATE BETWEEN 2006 AND 2010, AN UNKNOWN ENDURANT AUI STENT GRAFT (PLI10) AND AN UNKNOWN TALENT AUI STENT GRAFT (PLI 20) WERE IMPLANTED. DURING A RETROSPECTIVE STUDY OF 18 PATIENTS TREATED FOR AAA COMPLICATIONS, 9 OF WHICH WERE TREATED WITH EITHER AN ENDURANT AUI OR TALENT AUI, THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: PRE-OP RUPTURE, OPEN REPAIR, TYPE I ENDOLEAK, PNEUMONIA, CARDIAC ISCHEMIA, INFECTION, DEATH WITHIN 30 DAYS, AND TYPE II ENDOLEAK. METHODS: DATA WERE RECORDED PROSPECTIVELY. CRITERIA FOR AN EEVAR WERE AN INFRARENAL NECK> 15MM, ACCEPTABLE LANDING ZONE, ANGLES BELOW 70 DEGREES AND A GOOD FEMORAL APPROACH. WE PREFER PREOPERATIVE ANGIOGRAM CT-SCAN BUT IN CASE OF INSTABILITY, AN INTRA-AORTIC BALLOON CAN STABILIZE THE PATIENT DURING ANGIOGRAPHY (IN THE OR) TO DECIDE BETWEEN OPEN OR EEVAR REPAIR. FOLLOW-UP WAS PERFORMED ON REGULAR INTERVALS BY DUPLEX OR CT-SCAN. THIRTY-DAY MORTALITY AND OVERALL SURVIVAL WERE CALCULATED. RESULTS: SINCE 2006, NINE MALE RAAA PATIENTS WITH A MEAN AGE OF (B)(6) HAD EEVAR REPAIR. ANEURYSM DIAMETER WAS 8 CM (RANGE : 5.8-11 ). THE HARDMAN INDEX WAS 1.5 (RANGE : 0-3). IN EIGHT PATIENTS AN AORTO-UNI-ILIAC DEVICE WAS PLACED SUCCESSFULLY FOLLOWED BY A FEMORAL TO FEMORAL CROSSOVER BYPASS. THE 30-DAY OPERATIVE MORTALITY WAS 12.5% (ONE PATIENT WITH SEPTIC SHOCK). THREE PATIENTS SHOWED A TYPE 2 ENDOLEAK WITH STABLE DIAMETER DURING FOLLOW-UP BUT ONE PATIENT SHOWED EXPANSION 4 YEARS AFTER TREATMENT. CONCLUSIONS: TREATING RAAA WITH EEVAR IN SELECTED PATIENTS WITH ACCEPTABLE ANATOMY AND A KIT PERMANENTLY AVAILABLE IN THE OPERATING ROOM YIELDED GOOD RESULTS BY A SURGICAL TEAM TRAINED FOR BOTH OPEN AND EEVAR REPAIR. THE CONVERSION RATE WAS LOW (11 %) AND THE SURVIVAL (IMMEDIATE AND 30-DAYS) WAS EXCELLENT (87.5%). THE EXACT DATE OF DEATH IS UNKNOWN. PLEASE NOTE THAT THIS DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO A UNITED STATES DISTRIBUTED PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT AUI STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Death