BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT BIFURCATED STENT GRAFT

    MDR report key: 2180785 · Received July 22, 2011

    Report

    Report Number
    2953200-2011-01318
    Event Type
    Death
    Date Received
    July 22, 2011
    Report Date
    June 22, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: (OCCLUSION, INFECTION, ENDOLEAK, DEATH). (TYPE II ENDOLEAK). CONCLUSION: LACK OF EFFECTIVENESS (TYPE II ENDOLEAK).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION IN A JOURNAL ARTICLE ENTITLED "ONE-YEAR MULTICENTER RESULTS OF 100 CONSECUTIVE PATIENTS TREATED WITH THE ENDURANT STENT GRAFTS IN REAL-LIFE PRACTICE" (J VASC SURG 2011). 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 THE 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 (B)(6). VESSEL MORPHOLOGY WAS REPORTED AS AN AAA SIZE OF 61 +OR- 10 MM (31 TO 93 MM), AN AAA VOLUME OF 210 +OR- 122 ML (69 TO 934 ML), A PROXIMAL NECK LENGTH OF 33 +OR- 14 MM (9 TO 82 MM), AND AN INFRARENAL ANGULATION OF 44 +OR- 25 DEGREES (0 DEG -108 DEG). 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 +OR- 11.8 [32-80] MM; P < .01; VOLUME, 173 +OR- 119 [42-1028] ML; P< .01), AND ONE GRAFT MIGRATION >5MM 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 STENT GRAFT SYSTEM AND WITH 19 PERCENT 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. (J VASC SURG 2011). 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 MIH MEDTRONIC CARDIOVASCULAR IRELAND NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death