BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT II AUI STENT GRAFT

    MDR report key: 4090714 · Received September 15, 2014

    Report

    Report Number
    2953200-2014-01835
    Event Type
    Death
    Date Received
    September 15, 2014
    Date of Event
    October 3, 2014
    Report Date
    October 3, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. THE TYPE IV ENDOLEAK HAD RESOLVED; HOWEVER, THE PATIENT EXPIRED DUE TO AN INFECTION ACQUIRED IN THE HOSPITAL THAT RESULTED IN BACTEREMIA. THE PHYSICIAN NOTED THAT THE INFECTION DEVELOPED FROM A GROIN INFECTION LIKELY DUE TO THE PROCEDURE.

    Description of Event or Problem · 1

    AN ENDURANT AUI STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY WAS REPORTED AS THE PROXIMAL NECK DIAMETER RIGHT BELOW THE RENAL ARTERIES IS 19MM AND 26MM IN DIAMETER AT THE ANEURYSM ENTRY. DURING THE INDEX PROCEDURE THE ENDURANT AUI WAS DETERMINED TO BE THE GRAFT OF CHOICE SINCE THE PATIENT WAS OCCLUDED AT THE LEFT COMMON AND EXTERNAL ILIAC. THE AUI WAS DELIVERED SUCCESSFULLY AND USED A 16X16 TO EXTEND. A FINAL ANGIO WAS RUN AND REVEALED A JET OF CONTRAST COMING FROM THE AUI WHERE IT TRANSITIONS FROM THE 28MM TO 14MM DIAMETER. THE PHYSICIAN DECIDED TO CUFF UP USING A 28X49 AND SUBSEQUENTLY USED STAPLES, RE- BALLOONED AND TOOK ANOTHER RUN. THE JETTING CONTRAST WAS STILL PRESENT. THE PHYSICIAN DETERMINED THAT IT WAS NOT A TYPE I AND RULED OUT THE TYPE II SINCE NO ANCILLARY VESSELS WERE PRESENT TO FEED THE SAC. THE PHYSICIAN NOTED THAT IT APPEARED TO BE A TYPE IV. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL CONTINUE TO BE MONITORED BY THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570300 ENDURANT II AUI STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V05892610

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Death| R