BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2974396 · Received February 22, 2013

    Report

    Report Number
    2953200-2013-00326
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    January 30, 2013
    Report Date
    January 30, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (PRE-OPERATIVE DISSECTION); UNAPPROVED USE OF DEVICE (TREATMENT OF A PATIENT WITH A PRE-OPERATIVELY DISSECTED AORTA). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (PRE-OPERATIVE DISSECTION); USER ERROR CONTRIBUTED TO EVENT (TREATMENT OF A PATIENT WITH A PRE-OPERATIVELY DISSECTED AORTA).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 48 MM DIAMETER ABDOMINAL AORTIC ANEURYSM APPROXIMATELY THREE WEEKS AGO. THE AORTIC NECK WAS 33-28MM IN DIAMETER, AND 13MM LONG. A DISSECTION WAS PRESENT JUST BELOW THE RENAL ARTERIES PRIOR TO THE EVAR. IT WAS REPORTED THAT ON FINAL ANGIOGRAPHY THE PHYSICIAN REALIZED THAT THE LEVEL OF THE RENAL ARTERIES WAS MISREAD AND THE BIFURCATED STENT GRAFT WAS UNINTENTIONALLY DEPLOYED TOO FAR PROXIMALLY, COVERING THE RENAL ARTERIES, SUPERIOR MESENTERIC ARTERY, AND THE CELIAC ARTERY. THE PATIENT WAS IMMEDIATELY CONVERTED TO OPEN REPAIR AND THE STENT GRAFTS WERE EXPLANTED. A Y-GRAFT WAS SEWN ONTO THE AORTA. THE ONLY STENT GRAFTS REMAINING IN THE PATIENT ARE THE ENDURANT 1613124 (RIGHT EXTENSION) AND THE 131382 (LEFT EXTENSION). NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78922 ENDURANT ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01712621

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR