BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT

    MDR report key: 3872134 · Received June 13, 2014

    Report

    Report Number
    2953200-2014-01195
    Event Type
    Death
    Date Received
    June 13, 2014
    Date of Event
    January 1, 2011
    Report Date
    May 22, 2014
    Manufacturer
    MEDTRONIC 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, CONCLUSION:OFF-LABEL, UNAPPROVED, OR CONTRAINDICATED USE, (15 MM OF NECK LENGTH AND > 75 DEG OF ANGULATION OR 10 MM OF NECK LENGTH AND > 60 DEG OF ANGULATION).

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS OBTAINED FROM A JOURNAL ARTICLE; EVALUATION OF THE ENDURANT STENT GRAFT UNDER INSTRUCTIONS FOR USE VS OFF-LABEL CONDITIONS FOR ENDOVASCULAR AORTIC ANEURYSM REPAIR. GIOVANNI TORSELLO, MD, NICOLA TROISI, MD, KONSTANTINOS P. DONAS, MD, AND MARTIN AUSTERMANN, MD, MUNSTER, GERMANY; J VASC SURG 2011 THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: DEATH (EXACT DATE IS UNKNOWN), ILIAC STENTING FOR BRANCH STENOSIS, RENAL STENTING, PROXIMAL AORTIC CUFF, HYPOGASTRIC EMBOLIZATION, FEM-FEM PROSTHETIC CROSSOVER, ANEURYSMECTOMY FEMORAL ARTERY, MAJOR MORBIDITY, SYSTEMIC COMPLICATIONS, DEVICE RELATED COMPLICATIONS, ACCESS SITE COMPLICATIONS, POST IMPLANTATION SYNDROME AND RE-INTERVENTIONS. BACKGROUND: THIS STUDY EVALUATED THE EARLY AND INTERMEDIATE RESULTS OF ENDOVASCULAR AORTIC ANEURYSM REPAIR (EVAR) USING THE ENDURANT STENT GRAFT IN PATIENTS TREATED ACCORDING TO DEVICE-SPECIFIC INSTRUCTIONS FOR USE (IFU) FOR THE PROXIMAL AORTIC NECK COMPARED WITH THOSE OBTAINED IN PATIENTS TREATED IN AN OFF-LABEL (OL) SITUATION. METHODS: BETWEEN NOVEMBER 2007 AND MARCH 2010, 177 CONSECUTIVE PATIENTS WITH ABDOMINAL AORTIC ANEURYSMS (AAAS) WERE TREATED WITH THE ENDURANT STENT GRAFT AT OUR CENTERS. THE IFU FOR THE ENDURANT STENT GRAFT INCLUDED A PROXIMAL NECK OF 15 MM IN LENGTH AND <(><<)>75 DEG OF ANGULATION OR 10 MM OF NECK LENGTH AND <(><<)>60 DEG OF ANGULATION. THE 121 PATIENTS (68.4%) OPERATED ON ACCORDING TO IFU WERE COMPARED WITH 56 (31.6%) WHO UNDERWENT EVAR IN OL CIRCUMSTANCES TO EVALUATE SIGNIFICANT DIFFERENCES IN DEMOGRAPHICS, INTRAOPERATIVE TECHNICAL FACTORS, AND EARLY (30 DAYS) AND INTERMEDIATE OUTCOMES (1 YEAR). RESULTS: SIGNIFICANTLY MORE PATIENTS WERE AGED >80 YEARS IN THE OL GROUP (37.5% VS 19%, P _ .008), AND THEY ALSO HAD LARGER ANEURYSMS (59_10.6 VS 55.9_10.8 MM, P_.05) AND REQUIRED A LONGER PROCEDURE TIME (69.3_27.2 VS 60.8_20.4 MINUTES, P _ .02). AT 30 DAYS, THE RISK OF TYPE I ENDOLEAK WAS HIGHER IN THE OL GROUP (2 PATIENTS, 3.6% VS 0 IN IFU), BUT THIS DID NOT REACH STATISTICAL SIGNIFICANCE (P _ .09). THE TWO GROUPS WERE SIMILAR IN RATES OF PERIOPERATIVE MORTALITY, MAJOR MORBIDITY, TECHNICAL SUCCESS, CLINICAL SUCCESS, COMPLICATIONS, AND RE-INTERVENTIONS. AT 1 YEAR, THERE WERE NO DIFFERENCES BETWEEN THE TWO GROUPS IN SURVIVAL, FREEDOM FROM ANY DEVICE-RELATED RE-INTERVENTIONS, AND FREEDOM FROM GRAFT THROMBOSIS. ESTIMATED 1-YEAR FREEDOM FROM TYPE I ENDOLEAK WAS 100% IN THE IFU GROUP VS 93.3% IN THE OL GROUP (P _ .01). CONCLUSIONS: IN PATIENTS WITH BOTH NORMAL AND COMPLEX ANATOMY OF THE PROXIMAL AORTIC NECK, THE ENDURANT STENT GRAFT OBTAINED ACCEPTABLE RESULTS, WITH NO DIFFERENCE IN SURVIVAL, MORBIDITY, OR RE-INTERVENTIONS. HOWEVER, THERE WAS A GREATER RISK OF TYPE I ENDOLEAK LONGER TERM FOLLOW-UP IS REQUIRED TO EVALUATE THE EFFECTIVENESS OF THIS ENDOGRAFT IN PREVENTING LATE ANEURYSM-RELATED COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349031 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Death| R