BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT

    MDR report key: 4546678 · Received February 25, 2015

    Report

    Report Number
    2953200-2015-00361
    Event Type
    Death
    Date Received
    February 25, 2015
    Date of Event
    January 30, 2015
    Report Date
    January 30, 2015
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN ENDURANT 32 X32X49 AORTIC CUFF WAS IMPLANTED PROXIMALLY FOR THE SECONDARY INTERVENTION OF A PROXIMAL TYPE I ENDOLEAK OF AN TALENT BIFURCATED STENT GRAFT. THERE IS DISEASE PROGRESSION WITH AORTIC NECK DILATATION. THE UNKNOWN ENDOLEAK WAS RESOLVED. CURRENTLY THE PATIENT PRESENTED EMERGENTLY WITH A RUPTURED 8 CM IN DIAMETER ANEURYSM. THE PHYSICIAN MADE NO SUCH STATEMENT REGARDING DEVICE OR PROCEDURE RELATIONSHIP. THE PHYSICIAN CONTINUED TO MONITOR THE PATIENT, HOWEVER THE PATIENT¿S CARE WAS WITHDRAWN AND THE PATIENT EXPIRED. THE PHYSICIAN STATED THAT THE PATIENT¿S CONDITION AND BLOOD LOSS CAUSED DEATH. FILM REVIEW WAS COMPLETED. CTA¿S FROM 5 YEARS POST-IMPLANT WERE REVIEWED. FILMS WERE NON-CONTRAST. THE FILMS REVEALED THAT THE ENDURANT CUFF WAS POSITIONED JUST BELOW THE RENALS. THE PROXIMAL STENT GRAFT OD IS 27MM; THE CUFF IS ANGULATED 65DEG A-P RELATIVE TO THE LIMBS. THE PROXIMAL NECK IS SEVERELY CALCIFIED CIRCUMFERENTIALLY. THE TALENT BIFURCATE WAS POSITIONED APPROXIMATELY 2CM BELOW THE CUFF, AND AN UNKNOWN ANEURX CUFF WAS ALSO SEEN IMPLANTED ACROSS THE FLOW DIVIDER INTO THE LEFT LIMB AND APPEARS CLOSED OFF BY THE ENDURANT AORTIC CUFF. THE BIFURCATE IPSI LIMB WAS PLACED DOWN INTO THE RIGHT COMMON ILIAC ARTERY, AND THE CONTRA LIMB INTO THE LEFT COMMON ILIAC ARTERY. THERE IS MINIMAL SEALING LENGTH DISTALLY; BILATERALLY. LACK OF CONTRAST DOES NOT PERMIT ASSESSMENT OF ANY ENDOLEAK OR STENT GRAFT PATENCY. THE MAX DIAMETER AAA IS 10CM, AND THE AAA APPEARS TO HAVE RUPTURED. FROM THE (NON-CONTRAST) FILMS PROVIDED THE CAUSE OF THE ANEURYSM RUPTURE COULD NOT BE DETERMINED. EARLIER FILMS POST-IMPLANT WERE NOT AVAILABLE FOR REVIEW. THE SOURCE AND CAUSE OF THE POSSIBLE ENDOLEAK COULD NOT BE DETERMINED. IT IS POSSIBLE THAT CONTINUED DISEASE PROGRESSION (NECK DILATATION AND ANGULATION), THE CALCIFIED PROXIMAL NECK, AND THE MINIMAL DISTAL LIMB SEAL LENGTH MAY HAVE ALL CONTRIBUTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131420 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04667499

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Death