BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT BIFURCATED STENT GRAFT SYSTEM

    MDR report key: 2062099 · Received March 17, 2011

    Report

    Report Number
    2953200-2011-00664
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 15, 2011
    Report Date
    February 15, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: ENDOLEAK.

    Description of Event or Problem · 1

    AN ENDURANT BIFURCATED STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROXIMATELY ONE MONTH AGO. THE ANEURYSM AND VESSEL MORPHOLOGY WERE NOT REPORTED. IT WAS REPORTED THAT THE ACTIVATED CLOTTING TIME (ACT) WAS 250 AND AFTER THE BIFURCATED STENT GRAFT WAS IMPLANTED, THE PHYSICIAN NOTED THERE WAS A TYPE IV ENDOLEAK AT THE END OF THE PROCEDURE. NO FURTHER INTERVENTION WAS PERFORMED AND THE DECISION WAS MADE TO EVALUATE FOR THE ENDOLEAK AT THE 30 DAY F/U. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT BIFURCATED STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00826293

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR