BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT

    MDR report key: 3863944 · Received June 10, 2014

    Report

    Report Number
    2953200-2014-01172
    Event Type
    Death
    Date Received
    June 10, 2014
    Date of Event
    May 28, 2011
    Report Date
    May 22, 2014
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSIONS: (VARIOUS UNSPECIFIED OFF-LABEL ANATOMIES).

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS OBTAINED FROM A JOURNAL ARTICLE. ONE-YEAR MULTICENTER RESULTS OF 100 ABDOMINAL AORTIC ANEURYSM PATIENTS TREATED WITH THE ENDURANT STENT GRAFT. VAN KEULEN JW, DE VRIES JP, DEKKER H, GONÇALVES FB, MOLL FL, VERHAGEN HJ, VAN HERWAARDEN JA. (J VASC SURG. 2011 SEP;54(3):609-15). (B)(4). THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: INABILITY TO CANNULATE THE CONTRALATERAL GATE; UNPLANNED FEMORAL-FEMORAL BYPASS; UNINTENTIONAL VESSEL COVERAGE; INACCURATE PLACEMENT OF THE STENT GRAFT; ARTERIAL OCCLUSION; DEATH; VENTRICULAR TACHYCARDIA; GI BLEEDING; ABDOMINAL PAIN; ILIAC LIMB OCCLUSION; ISCHEMIA; BLOOD LOSS; STENT GRAFT INFECTION; FEVER; ENDOLEAKS; POST-OPERATIVE AORTIC RUPTURE; ANEURYSM ENLARGEMENT; STENT GRAFT MIGRATION; AND RENAL IMPAIRMENT. NO FURTHER INFORMATION IS AVAILABLE FOR THESE EVENTS. OBJECTIVE: THE ENDURANT (B)(4) IS A NEW STENT GRAFT SPECIFICALLY DESIGNED TO MAKE MORE PATIENTS ANATOMICALLY ELIGIBLE FOR ENDOVASCULAR ANEURYSM (EVAR). THIS STUDY PRESENTS THE 1-YEAR RESULTS OF 100 CONSECUTIVE PATIENTS WITH ABDOMINAL AORTIC ANEURYSMS (AAAS) TREATED WITH THE ENDURANT STENT GRAFT IN REAL-LIFE PRACTICE. METHODS: ALL CLINICAL PREOPERATIVE, OPERATIVE, POSTOPERATIVE, AND 1-YEAR FOLLOW-UP DATA OF PATIENTS WITH THE ENDURANT STENT GRAFT FROM THREE TERTIARY CENTERS WERE PROSPECTIVELY COLLECTED. PATIENTS UNDERWENT COMPUTED TOMOGRAPHIC ANGIOGRAPHY (CTA) PREOPERATIVELY, AT 1 MONTH, AND AT 1-YEAR POST-EVAR. THE FIRST 100 PATIENTS WITH AN IMPLANTATION DATE AT LEAST 1 YEAR BEFORE OUR DATE OF ANALYSIS AND COMPLETE INFORMATION WERE INCLUDED. CLINICAL DATA, AAA CHARACTERISTICS, PRESENCE OF ENDOLEAKS, GRAFT MIGRATION, AND OTHER EVAR-RELATED COMPLICATIONS WERE NOTED. ALL VALUES ARE STATED AS MEAN ± SD (RANGE). RESULTS: THIS STUDY INCLUDED 100 PATIENTS WITH AAAS (88 MEN) WITH A MEAN AGE OF 73 ± 8 YEARS (47 TO 87 YEARS), AN AAA SIZE OF 61 ± 10 MM (31 TO 93 MM), AN AAA VOLUME OF 210 ± 122 ML (69 TO 934 ML), A PROXIMAL NECK LENGTH OF 33 ± 14 MM (9 TO 82 MM), AND AN INFRARENAL ANGULATION OF 44 ± 25° (0°-108°). NINETEEN OF THE 100 INCLUDED PATIENTS HAD AT LEAST ONE ANATOMIC CHARACTERISTIC THAT WAS CONSIDERED A VIOLATION OF THE INSTRUCTIONS FOR USE (IFU) OF THE ENDURANT STENT GRAFT. A PRIMARY TECHNICAL SUCCESS WAS ACHIEVED IN 98% OF THE PATIENTS (ONE ADDITIONAL STENT PLACEMENT IN RENAL ARTERY WAS REQUIRED; ONE UNPLANNED AORTO-UNI-ILIAC DEVICE PLACED), WITH NO PRIMARY TYPE I OR III ENDOLEAKS OR CONVERSIONS. A SECONDARY TECHNICAL SUCCESS WAS ACHIEVED IN ALL CASES. THE 30-DAY MORTALITY WAS 2% AND THE FIRST POSTOPERATIVE CTA DOCUMENTED 16 ENDOLEAKS (16%; 16 TYPE II). ONE-YEAR FOLLOW-UP SHOWED THREE ILIAC LIMB OCCLUSIONS (3%), ONE INFECTED STENT GRAFT (CAUSING A TYPE IA ENDOLEAK), AND FIVE ENDOVASCULAR REINTERVENTIONS (5%; THREE TO TREAT ILIAC LIMB OCCLUSIONS, ONE PROXIMAL EXTENSION CUFF; AND ONE STENT IN THE RENAL ARTERY). THE 1-YEAR ALL-CAUSE MORTALITY RATE WAS 12% (12 PATIENTS) AND THE AAA-RELATED MORTALITY WAS 3%. THE MEAN AAA SIZE WAS SIGNIFICANTLY SMALLER AFTER 1 YEAR (DIAMETER, 54 ± 11.8 [32-80] MM; P - .01; VOLUME, 173 ± 119 [42-1028] ML; P - .01), AND ONE GRAFT MIGRATION >5 MM AND 13 ENDOLEAKS WERE NOTED (12 TYPE II, 1 TYPE I [NECK DILATATION]). CONCLUSION: THE TREATMENT OF PATIENTS WITH AAAS WITH THE ENDURANT STENT GRAFT SEEMS TO BE SUCCESSFUL AND DURABLE DURING THE FIRST YEAR AFTER EVAR. DESPITE THE WIDER INCLUSION CRITERIA FOR THE ENDURANT, AND WITH 19% OF OUR PATIENTS TREATED OUTSIDE THE IFU, THE AAA-RELATED MORTALITY, NUMBER OF TYPE I OR III ENDOLEAKS, AND REINTERVENTION RATES ARE COMPARABLE TO THE RESULTS OF OTHER STENT GRAFTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339005 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Death| R