BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 3041562 · Received April 8, 2013

    Report

    Report Number
    2953200-2013-00642
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 13, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK). PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (80 DEGREE NECK ANGULATION). UNAPPROVED USE OF DEVICE (AORTIC NECK ANGULATION GREATER THAN 60 DEGREES). EVALUATION CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (80 DEGREE NECK ANGULATION) 80 USER ERROR CONTRIBUTED TO EVENT (AORTIC NECK ANGULATION GREATER THAN 60 DEGREES).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 9.7 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. THE PROXIMAL AORTIC NECK IS 25 MM IN DIAMETER. THE AORTIC NECK HAD 80 DEGREE ANGULATION. THE ILIAC ARTERIES ARE HEAVILY CALCIFIED. THE PATIENT IS NOT A SURGICAL CANDIDATE. IT WAS REPORTED THAT THE PATIENT HAS ADEQUATE ACCESS BUT THE NECK HAS ABOUT 80 DEGREE ANGULATION. THE PHYSICIAN PLACED A PROXIMAL CUFF IN FIRST AND THEN THE BIFURCATED STENT GRAFT AFTER. THE PHYSICIAN THEN CANNULATED THE GATE AND EXTENDED TO GRAFT INTO THE COMMON ILIAC. THE PHYSICIAN THEN REMOVED THE MAIN BODY DEVICE AND PLACED AN EXTENSION TO THE COMMON ILIAC. HE PLACED THE MAIN BODY FROM THE LEFT AND THE CONTRALATERAL LIMBS FROM THE RIGHT. THE PHYSICIAN BALLOONED THE STENT GRAFT WITH A RELIANT BALLOON. ON THE POST ANGIOGRAM IT WAS NOTED THAT THERE WAS A PROXIMAL TYPE I ENDOLEAK. THE STENT GRAFT WAS APPROXIMATELY 1 CM OFF THE RENAL ARTERY SO A SECOND PROXIMAL CUFF WAS IMPLANTED. AFTER BALLOONING THE FINAL ANGIOGRAM SHOWED THAT THERE WAS STILL A VERY FAINT PROXIMAL TYPE I ENDOLEAK. THE PHYSICIAN WAS TOLD BY THE CRNA THAT THE PATIENT URINE OUTPUT HAD SLOWED AND THE PATIENT HAD LOST ABOUT 2-300 CC OF BLOOD AT THE TIME AND IS RENAL COMPROMISED. THE RENAL ARTERIES WERE NOT COVERED DURING THE PROCEDURE. THE DECISION WAS MADE TO STOP AND ADDRESS THE LEAK LATER. THE PHYSICIAN FELT HE NEEDED TO GET THE PATIENT OUT OF THE OR AND TO RECOVERY. A FEW DAYS LATER, A DUPLEX ULTRASOUND WHICH SHOWED NO FLOW IN THE ANEURYSM SAC. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143377 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01047007

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR