BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 1993811 · Received February 11, 2011

    Report

    Report Number
    2953200-2011-00376
    Event Type
    Injury
    Date Received
    February 11, 2011
    Date of Event
    January 13, 2011
    Report Date
    January 13, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P10021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS OF EVAL: (OCCLUSION), (MODERATELY TORTUOUS VESSELS). CONCLUSION: (MODERATELY TORTUOUS VESSELS).

    Description of Event or Problem · 1

    AN ENDURANT BIFURCATED STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A SACCULAR 9.9 CM ABDOMINAL AORTIC ANEURYSM APPROX TWO MONTHS AGO. THE AORTIC NECK WAS 27 TO 30 MM IN DIAMETER BUT ENLARGES TO 33 MM IN THE MIDDLE SECTION, 28.8 MM LONG, WITH MILD ANGULATION AND MILD CALCIFICATION. VESSELS WERE MODERATELY TORTUOUS AND MILDLY CALCIFIED. AFTER DEPLOYMENT, A TYPE IV LEAK WAS SEEN IN THE BIFURCATED STENT GRAFT (REF MFR 2953200-2011-00375). IT WAS REPORTED ONE MONTH POST INITIAL PROCEDURE, THE TYPE IV ENDOLEAK WAS RESOLVED WITH OUT FURTHER INTERVENTION. HOWEVER, AN OCCLUSION OF THE LEFT SIDE/IPSILATERAL EXTENSION WAS NOTED. NO FURTHER DIAGNOSTIC PROCEDURE HAS BEEN PERFORMED TO DETERMINE THE CAUSE OF THE OCCLUSION OR TO PLAN AN INTERVENTION, AS THE PT HAS CHRONIC RENAL FAILURE AND IS ACUTELY CRITICALLY ILL. NO INTERVENTION HAS BEEN PERFORMED. NO ADD'L CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00530389

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention