BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT

    MDR report key: 4225499 · Received November 4, 2014

    Report

    Report Number
    2953200-2014-02312
    Event Type
    Death
    Date Received
    November 4, 2014
    Date of Event
    December 21, 2013
    Report Date
    October 10, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS OBTAINED FROM A JOURNAL ARTICLE. ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR USING TRANSVENOUS INTRAVASCULAR US CATHETER GUIDANCE IN PATIENTS WITH CHRONIC RENAL FAILURE. ALEXANDER BELENKY, ELI ATAR, DAN E. ORRON, SERGEY LITVIN, MICHAEL KNIZHNIK, MAZAL ALMOG, IDA TSADIK, IGOR MANEVYCH, AND MENASHE HADDAD. J VASCINTERVRADIOL2014;25:702¿706. ON UNKNOWN DATES AN ENDURANT STENT GRAFT WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A 7CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: ACUTE RENAL FAILURE, DEATH. PURPOSE TO DESCRIBE THE TRANSVENOUS APPLICATION OF INTRACARDIAC ECHOCARDIOGRAPHY (ICE) FOR GUIDANCE DURING ENDOVASCULAR AORTIC REPAIR (EVAR). MATERIALS AND METHODS- EIGHT PATIENTS WITH AN INFRARENAL ABDOMINAL AORTIC ANEURYSM (AAA) AND CHRONIC RENAL FAILURE WERE DETERMINED SUITABLE FOR EVAR. THE PROCEDURE WAS PERFORMED BY DEPLOYING THE TRANSCAVAL AND TRANSILIAC VEIN GUIDANCE OF AN ICE CATHETER TO REDUCE THE DOSAGE OF IODINATED CONTRAST MEDIUM. MULTIPLE GUIDANCE PARAMETERS WERE ASSESSED. THE PRESENT STUDY DESCRIBES THE EVAR PROCEDURE AND POSTPROCEDURE TRANSABDOMINAL ULTRASOUND (US) FOLLOW-UP RESULTS AT 3¿4 MONTHS. RESULTS- THE EIGHT PROCEDURES WERE COMPLETED BY USING TRANSVENOUS ICE GUIDANCE. NO CONTRAST MEDIUM WAS USED IN FIVE PATIENTS, AND 3¿20 ML OF ISOOSMOLAR CONTRAST MEDIUM WAS ADMINISTERED IN THE OTHER THREE. NO ENDOLEAKS WERE DETECTED BY ICE IMMEDIATELY AFTER STENT DEPLOYMENT. ONE PATIENT WHO HAD A SINGLE FUNCTIONING KIDNEY DEVELOPED RENAL FAILURE THAT WAS ATTRIBUTED TO MANIPULATION-RELATED CHOLESTEROL EMBOLIZATION. THAT PATIENT BECAME DEPENDENT ON DIALYSIS AND DIED 3.5 MONTHS AFTER THE PROCEDURE. NO ENDOLEAKS WERE DETECTED AT 3¿4-MONTH US FOLLOW-UP IN THE OTHER SEVEN PATIENTS. CONCLUSIONS- TRANSVENOUS ICE GUIDANCE IS A PROMISING METHOD TO REDUCE THE DOSAGE OF IODINATED CONTRAST MEDIUM IN PATIENTS WITH RENAL DYSFUNCTION UNDERGOING EVAR. A PROSPECTIVE TRIAL COMPARING THIS MODALITY VERSUS DIGITAL SUBTRACTION ANGIOGRAPHY GUIDANCE WITH IODINATED CONTRAST MEDIUM IN TERMS OF SAFETY, ACCURACY, AND LONG-TERM EFFICACY IS RECOMMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705451 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Death| R