BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT

    MDR report key: 3667912 · Received March 7, 2014

    Report

    Report Number
    2953200-2014-00394
    Event Type
    Death
    Date Received
    March 7, 2014
    Date of Event
    November 28, 2013
    Report Date
    February 14, 2014
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    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

    (B)(4). EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAKS, SURGICAL CONVERSION, BYPASS, OCCLUSION, INTRA-PROSTHETIC THROMBOSIS, ISCHEMIA DUE TO PERFUSION FAILURE, INFECTION OR MIGRATION OF THE PROSTHESIS, EXPANDING ANEURISMAL SAC, AND DEATH); (UNKNOWN CAUSE OF EVENTS). CONCLUSION: (UNKNOWN CAUSE OF EVENTS).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE: CLINICAL AND RADIOLOGICAL OUTCOME AFTER ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR: COMPARISON OF DIFFERENT GRAFTS. PRELIMINARY SINGLE-CENTER EXPERIENCE. AUTHORS, GRETA GARB0, RAFFAELLA MOTTA, GIORGIO BIANCHERA, OSCAR ZINI, LUCA, SPIGOLON , ANTONIO ZANON AND FRANCO LUMACHI. IN VIVO (INTERNATIONAL JOURNAL OF EXPERIMENTAL AND CLINICAL PATHOPHYSIOLOGY AND DRUG RESEARCH 28: 117-120 (2014) NOVEMBER 28, 2013 THE REPORTED EVENTS REQUIRING INTERVENTION ARE: ENDOLEAKS, MIGRATION, SURGICAL CONVERSION, BYPASS, OCCLUSION, INTRA-PROSTHETIC THROMBOSIS, ISCHEMIA DUE TO PERFUSION FAILURE, INFECTION OR MIGRATION OF THE PROSTHESIS, EXPANDING ANEURISMAL SAC, AND DEATH. ABSTRACT: ENDOVASCULAR REPAIR (EVAR) REPRESENTS A USEFUL AND VALIDATED ALTERNATIVE TO CONVENTIONAL SURGERY IN SELECTED PATIENTS WITH ABDOMINAL AORTIC ANEURYSM (AAA) BECAUSE IT IS ASSOCIATED WITH A SIGNIFICANTLY LOWER LONG-TERM AAA-RELATED MORTALITY. DATA REGARDING A SERIES OF 91 PATIENTS (88 MEN, 3 WOMEN, MEDIAN AGE 71 YEARS, RANGE 65-82 YEARS) IS REPORTED. THE PATIENTS WERE DIVIDED INTO THREE GROUPS, ACCORDING TO THE TYPE OF IMPLANTED STENT (ENDURANT, EXCLUDER AND TALENT). HIGH AMERICAN SOCIETY OF ANESTHESIOLOGISTS PHYSICAL STATUS CLASSIFICATION SYSTEM (ASA) WAS IMPORTANT IN INCREASING THE LIKELIHOOD OF AN EARLY COMPLICATION (P=0.0007), WHILE IT DID NOT HAVE ANY EFFECT ON LATER ADVERSE EVENTS, WHICH WERE MORE CLOSELY RELATED TO THE SIZE OF THE ANEURYSM (P=0.006). AS EXPECTED, THE ANEURYSM DIAMETER INFLUENCED THE ENDOLEAK INCIDENCE (P=0.011), ANEURYSMAL SAC EXPANSION (P=0.029), RE-INTERVENTION RISK (P=0.031) AND THE SUCCESS OF TREATMENT (P=0.006). A SIGNIFICANTLY LOWER TENDENCY FOR THE DEVELOPMENT OF ENDOLEAK (P=0.035) AND OTHER LATE COMPLICATIONS (P=0.048) WAS OBSERVED IN PATIENTS WITH ENDURANT DEVICE. THIS GROUP SEEMS TO BE MORE LIKELY DESTINED TO ACHIEVE THERAPEUTIC SUCCESS, BUT THE DIFFERENCE WAS NOT SIGNIFICANT. A BORDERLINE SIGNIFICANCE (P=0.071) WITH REGARD TO EARLY COMPLICATIONS WAS ALSO RECORDED. HOWEVER, THE USE OF THIS TYPE OF DEVICE DID NOT AFFECT SURVIVAL, WHICH WAS EXCLUSIVELY RELATED TO ASA (P=0.040). NO OTHER STATISTICALLY SIGNIFICANT DIFFERENCES WERE FOUND BETWEEN GROUPS. SINCE OPEN SURGERY FOR ELECTIVE SUPRARENAL AAA REPAIR IS STILL ASSOCIATED WITH CONSIDERABLE MORTALITY, EVAR MAY OFFER SEVERAL ADVANTAGES OVER OPEN REPAIR SURGERY, INCLUDING A LESS INVASIVE OPERATIVE PROCEDURE, AND SHORTENED INTENSIVE CARE UNIT AND HOSPITAL STAY. THE TECHNOLOGICAL IMPROVEMENTS OF THE PROSTHESIS FOR EVAR WILL LIKELY REDUCE COMPLICATIONS RELATED TO THIS TECHNIQUE IN THE NEAR FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139699 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Required Intervention