BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2193891 · Received August 2, 2011

    Report

    Report Number
    2953200-2011-01369
    Event Type
    Injury
    Date Received
    August 2, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 5, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS OF EVALUATION: (ENDOLEAK). RESULTS AND CONCLUSION: (BARREL-SHAPED AORTIC NECK; SEVERELY CALCIFIED AORTA). (TREATMENT OF ONLY A PENETRATING ULCER WITHOUT AN ABDOMINAL ANEURYSM; POSSIBLE INSUFFICIENT COMPONENT OVERLAP).

    Description of Event or Problem · 1

    AN ENDURANT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 34 MM IN DIAMETER SACCULAR PENETRATING ULCER APPROXIMATELY 2 CM BELOW THE LOWEST RENAL ARTERY AND ENDING APPROXIMATELY 2.5 CM ABOVE THE AORTIC BIFURCATION. THE AORTIC NECK RANGES IN DIAMETER FROM 20 MM PROXIMALLY TO 16 MM AND THEN ENLARGES TO 20 MM DISTALLY OVER A LENGTH OF 2 CM. BOTH PROXIMAL AND DISTAL LANDING ZONES WERE SEVERELY CALCIFIED, AND THE COMMON ILIAC ARTERIES WERE CALCIFIED BILATERALLY. IT WAS REPORTED THAT AN ANEURX CUFF (MFR REPORT #2952200-2011-01368) AND AN ENDURANT CUFF (MFR REPORT #2952200-2011-01369) WERE IMPLANTED IN THE AORTIC NECK WITH 2 CM OF OVERLAP; HOWEVER, A JUNCTIONAL TYPE III ENDOLEAK WAS EVIDENT. THE PHYSICIAN DECIDED TO RELINE THE JUNCTION AREA WITH AN ANEURX CUFF; HOWEVER, IT WAS NOT POSSIBLE TO ADVANCE THE DELIVERY SYSTEM OF THE ANEURX CUFF, AS THE TAPER TIP WAS CATCHING ON THE BOTTOM SIDE OF THE FIRST ANEURX CUFF STENT GRAFT. THE PHYSICIAN AGGRESSIVELY BALLOONED THE JUNCTION WITH A RELIANT BALLOON, AND 30 MINUTES LATER THE JUNCTIONAL TYPE III ENDOLEAK WAS RESOLVED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00793835

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention