BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2681403 · Received August 3, 2012

    Report

    Report Number
    2953200-2012-01491
    Event Type
    Death
    Date Received
    August 3, 2012
    Report Date
    July 10, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: INHERENT RISK OF PROCEDURE (RENAL FAILURE, INFECTION, FEVER, STENT GRAFT MIGRATION, DEATH). PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (CHALLENGING ANATOMY, SHORT AORTIC NECK). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (CHALLENGING ANATOMY, SHORT AORTIC NECK).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED: AAA WITH A CHALLENGING NECK: EARLY OUTCOMES USING THE ENDURANT STENT-GRAFT SYSTEM. 0.1016/J.EJVS.2012.04.031. ENDURANT STENT GRAFTS WERE IMPLANTED BETWEEN 18 AND 30 MONTHS AGO DURING A RETROSPECTIVE STUDY OF 236 PATIENTS TREATED FOR AAA COMPLICATIONS, THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: RENAL DYSFUNCTION, DEATH, WOUND INFECTION, FEVER, MIGRATION. A RETROSPECTIVE STUDY CONDUCTED ON A PROSPECTIVELY COMPILED DATABASE OF 72 ELECTIVE PATIENTS WITH CHALLENGING NECK TREATED WITH THE ENDURANT SYSTEM. THESE PATIENTS WERE COMPARED TO A CONTROL GROUP ((B)(4)) WITHOUT SIGNIFICANT NECK PROBLEMS. ENDPOINTS WERE EARLY TECHNICAL AND CLINICAL SUCCESS, DEPLOYMENT ACCURACY AND DIFFERENCES IN OPERATIVE DETAILS AT ONE MONTH FOLLOW-UP. DATA ARE REPORTED AS MEAN AND STANDARD DEVIATION OR AS ABSOLUTE FREQUENCY AND PERCENTAGE (%). NORMALITY DISTRIBUTION AND HOMOGENEITY OF VARIANCES WERE TESTED BY SHAPIRO WILKS AND LEVENE TESTS, RESPECTIVELY. INTER-GROUP COMPARISONS FOR EACH VARIABLE WERE MADE BY T-TEST OR C2-TEST OR FISHER EXACT TEST. A P 0.05 WAS CONSIDERED STATISTICALLY SIGNIFICANT. RESULTS: MEAN AGE WAS (B)(6) YEARS; 76.6% WERE MALES. RISK FACTORS AND PRE-OPERATIVE VARIABLES DID NOT DIFFER SIGNIFICANTLY BETWEEN THE TWO GROUPS. MEAN NECK LENGTH WAS 10.56 MM IN PATIENTS WITH CHALLENGING ANATOMIES AND 22.85 MM IN CONTROLS. PATIENTS WITH A CHALLENGING NECK DIFFERED SIGNIFICANTLY (P 0.001) FROM CONTROLS IN TERMS OF MEAN INFRARENAL (37.67 VS. 20.12 ) AND SUPRARENAL ANGLE (19.63 VS. 15.57 ); 82% OF PATIENTS WITH A CHALLENGING NECK WERE ASA III/IV (VS. 86%). TECHNICAL SUCCESS WAS 100%, WITH FOUR UNPLANNED PROXIMAL EXTENSION IN CHALLENGING GROUP. NO TYPE I ENDOLEAKS OR ANEURYSM-RELATED DEATHS OCCURRED IN EITHER GROUP; MAJOR COMPLICATIONS WERE 1.54% VS. 1.39% (P ¼ 0.942). OPERATIVE DETAILS WERE SIMILAR IN BOTH GROUPS. CONCLUSION: TREATMENT WITH THE ENDURANT STENT-GRAFT IS TECHNICALLY FEASIBLE AND SAFE, YIELDING SATISFACTORY RESULTS EVEN IN CHALLENGING ANATOMIES. MEDIUM- AND LONG-TERM DATA ARE NEEDED TO VERIFY DURABILITY, BUT EARLY RESULTS ARE PROMISING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Required Intervention