BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2000390 · Received February 18, 2011

    Report

    Report Number
    2953200-2011-00442
    Event Type
    Injury
    Date Received
    February 18, 2011
    Date of Event
    January 20, 2011
    Report Date
    January 20, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: (STENT GRAFT MISPLACEMENT, ENDOLEAK). (AORTIC NECK WAS ANGULATED >90DEG, SHORT, AND CONICAL). EVAL, CONCLUSION: (AORTIC NECK WAS ANGULATED >90DEG, SHORT, AND CONICAL).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A 5.1 CM ABDOMINAL AORTIC ANEURYSM APPROXIMATELY ONE MONTH AGO. VESSEL MORPHOLOGY WAS REPORTED AS THE AORTIC NECK WAS ANGULATED >90DEG, SHORT, AND CONICAL, PROXIMALLY THE DIAMETER WAS 21 MM AND DISTALLY THE DIAMETER WAS 28.7, THE LENGTH WAS 1 CM. IT WAS REPORTED THAT THE FIRST 4-5 STENTS WERE OPENED AND THEN THE ANCHORING PINS WERE DEPLOYED; HOWEVER, THE DEVICE WIND SOCKED DOWN. THERE WAS A PROXIMAL TYPE 1 ENDOLEAK THAT WAS RESOLVED WITH A CUFF. NO CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00796636

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention