BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2080603 · Received April 22, 2011

    Report

    Report Number
    2953200-2011-00871
    Event Type
    Injury
    Date Received
    April 22, 2011
    Date of Event
    January 21, 2011
    Report Date
    March 25, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: (ARTERIAL OCCLUSION). RESULTS/CONCLUSIONS: (MILDLY TORTUOUS AND STENOSED ILIAC ARTERIES).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 6.4 CM DIAMETER SACCULAR ABDOMINAL AORTIC ANEURYSM 10 MONTHS AGO. THE PATIENT HAS A HISTORY OF TOBACCO USE, HYPERTENSION, CARDIAC DISEASE, ANGINA AND GI COMPLICATIONS. THE RIGHT ILIAC WAS MILDLY TORTUOUS WITH 50% STENOSIS. THE LEFT ILIAC WAS MODERATELY TORTUOUS WITH 30% STENOSIS. IT WAS REPORTED THAT AT THE PATIENT'S FOLLOW UP APPOINTMENT APPROXIMATELY THREE MONTHS AGO THE ANEURYSM WAS 6.1 CM IN DIAMETER. A DUPLEX SCAN WAS DONE DEMONSTRATING THAT THE RIGHT LIMB OF THE STENT GRAFT HAD GREATER THAN 50% STENOSIS. THE PATIENT HAD AN ELECTIVE ADMISSION FOR AN ANGIOGRAM ON (B)(6) 2011 AND AN ASSURANT BALLOON EXPANDING STENT WAS IMPLANTED (REF MFR # 2953200-2011-00872). THE INVESTIGATOR ASSESSED THE STENOSIS TO BE RELATED TO THE DEVICE AND NOT RELATED TO THE PROCEDURE. 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 SANTA ROSA NA V00201237

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention