BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT

    MDR report key: 3964581 · Received July 29, 2014

    Report

    Report Number
    2953200-2014-01475
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    April 22, 2014
    Report Date
    July 3, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CTA¿S FROM 4 YEARS POST-IMPLANT WERE REVIEWED. SINCE THE FILMS WERE NON-CONTRAST, ACCURATE MEASUREMENTS, ANY POSSIBLE ENDOLEAK, AND ASSESSMENT OF LUMEN PATENCY COULD NOT BE PERFORMED. THE FILMS REVEALED THAT THE BIFURCATE WAS POSITIONED WITHIN THE ANGULATED PROXIMAL NECK; THE NECK AND BIFURCATE AORTIC BODY WERE ANGULATED 75DEG A-P AND 75DEG RIGHT-LEFT TO THE LIMBS. THE STENT GRAFT PROXIMAL OD MEASURED 26 X 30MM. JUST BELOW THE PROXIMAL MARGIN THE NECK APPEARED DILATED OUT TO APPROXIMATELY 36X38MM. THE IPSI LIMB AND EXTENSION WERE POSITIONED DOWN INTO THE LEFT COMMON ILIAC, AND THE CONTRA LIMB AND EXTENSION INTO THE RIGHT COMMON ILIAC ARTERY. THE MAXIMUM AAA DIAMETER MEASURED 6.2CM. NO STENT GRAFT KINK, COMPRESSION, OR ANY STENT GRAFT ISSUES WERE OBSERVED. SINCE THE FILMS WERE NON-CONTRAST, THE REPORTED UNKNOWN TYPE ENDOLEAK COULD NOT BE ASSESSED. EARLIER POST-IMPLANT FILMS WERE NOT AVAILABLE FOR RETURN. THE CAUSE COULD NOT BE DETERMINED; HOWEVER, IT IS POSSIBLE THAT THE PROXIMAL NECK MAY HAVE DILATED WHICH COULD HAVE CONTRIBUTED TO A PROXIMAL TYPE I ENDOLEAK DUE TO THE SHORT PROXIMAL SEAL LENGTH. THE ANGULATED PROXIMAL NECK MAY HAVE ALSO CONTRIBUTED.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR ENDOVASCULAR TREATMENT OF A 6.7 CM IN DIAMETER ABDOMINAL AORTA ANEURYSM. VESSEL MORPHOLOGY WAS REPORTED AT THE TIME OF INDEX PROCEDURE THE LENGTH OF PROXIMAL AORTA NECK IS 50 MM, THE DIAMETER OF THE PROXIMAL AORTIC NECK IS 27 MM AND HE AORTIC NECK ANGULATION IS 60 DEGREES INFRA-RENAL. IT WAS REPORTED THAT THE CT WITHOUT CONTRAST REVEALED THAT THERE IS AN UNKNOWN ENDOLEAK IN THE PROXIMAL AREA AND THE ANEURYSM IS 7.2 CM IN DIAMETER. THE INVESTIGATOR STATED THAT THERE WAS DIAMETER GROWTH OF THE PROXIMAL SEAL. THE PHYSICIAN WILL CONTINUE TO MONITOR THE PATIENT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440998 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00424069

    Patients

    Seq Age Sex Outcome Treatment
    1 00090 YR