BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT BIFURCATED STENT GRAFT SYSTEM

    MDR report key: 2180834 · Received July 22, 2011

    Report

    Report Number
    2953200-2011-01332
    Event Type
    Death
    Date Received
    July 22, 2011
    Report Date
    June 23, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: (OCCLUSION, ENDOLEAK, DEATH). (TYPE II ENDOLEAK). EVALUATION, CONCLUSION: (TYPE II ENDOLEAK).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION IN A JOURNAL ARTICLE ENTITLED "THE ENDURANT STENT GRAFT SYSTEM: A 15-MONTH FOLLOW-UP REPORT OF A CONSECUTIVE SERIES OF 50 PATIENTS, WITH CHALLENGING ABDOMINAL AORTIC ANATOMIES" (LANGENBECKS ARCH SURG DOI 10.1007/S00423-011-0806-7). THESE PATIENTS UNDERWENT ENDOVASCULAR ABDOMINAL AORTIC REPAIR (EVAR) AT THREE (B)(6), BETWEEN 32 MONTHS AGO AND 36 MONTHS AGO. EVAR WAS ELECTIVE IN 48 CASES AND EMERGENT IN TWO. PATIENTS HAD SHORT (LESS THAN OR EQUAL TO 15 MM) AORTIC NECKS, SEVERE SUPRARENAL/INFRARENAL ANGULATION, AND/OR SMALL (<8 MM), CALCIFIED, SEVERELY ANGULATED, OR TORTUOUS ILIAC OR FEMORAL ACCESS VESSELS. ADDITIONALLY, A COHORT OF 40 PATIENTS WITHOUT CHALLENGING ANATOMIES WAS RETROSPECTIVELY ANALYZED TO CLARIFY DIFFERENCES CONCERNING TECHNICAL SUCCESS, MORTALITY, AND MORBIDITY BETWEEN THESE GROUPS. RESULTS: THE PRIMARY TECHNICAL SUCCESS RATE WAS 92% (46/50). THE 30-DAY MORTALITY RATE WAS 2% (1/50), THE DEATH WAS DUE TO MULTIORGAN FAILURE. INTRAOPERATIVE ANGIOGRAMS REVEALED THREE TYPE I ENDOLEAKS (2 PROXIMAL AND 1 DISTAL), AND ONE OF THOSE WAS PERSISTING AT 30 DAYS (30-DAY RATE, 2%). POSTOPERATIVE IMAGING DISCOVERED NO FURTHER TYPE I OR TYPE III ENDOLEAKS. THE 30-DAY RATE OF THE TYPE II ENDOLEAK WAS 6% (3/50). THERE WERE TWO CASES OF GRAFT LIMB OCCLUSION, BOTH REQUIRING REINTERVENTION WITHIN 30 DAYS. FOLLOW-UP WAS AVAILABLE IN ALL OF THE 50 PATIENTS (100%) OVER A MEDIAN OF 15 MONTHS (1-25). DURING THIS TIME, SEVEN PATIENTS DIED (OVERALL MORTALITY, 16%; 8/50), BESIDES THE ABOVE-DESCRIBED PATIENT, ALL OF THEM WERE UNRELATED TO THE PROCEDURE. COMPARED TO THE 30-DAY RESULTS WITH THE ENDURANT STENT GRAFT IN NON-CHALLENGING ANATOMIES (NO TYPE I ENDOLEAK; NO GRAFT LIMB OCCLUSION; ALL-CAUSE MORTALITY, 0%), PROCEDURE-RELATED COMPLICATIONS IN CHALLENGING ANATOMIES ARE INCREASING. CONCLUSION: EARLY AND 15-MONTH RESULTS WITH THE ENDURANT STENT GRAFT IN PATIENTS WITH CHALLENGING AORTIC ANATOMIES ARE ENCOURAGING. THE AUTHOR HAS BEEN CONTACTED FOR FURTHER INFORMATION. THIS EVENT DOES NOT MATCH PREVIOUS EVENTS REPORTED TO MEDTRONIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT BIFURCATED STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR IRELAND NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death