BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT STENT GRAFT SYSTEM

    MDR report key: 2801357 · Received October 23, 2012

    Report

    Report Number
    2953200-2012-02012
    Event Type
    Injury
    Date Received
    October 23, 2012
    Date of Event
    September 25, 2012
    Report Date
    September 25, 2012
    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: INHERENT RISK OF PROCEDURE (ENDOLEAK); (CAUSE IS UNKNOWN). CONCLUSION: (CAUSE IS UNKNOWN).

    Description of Event or Problem · 1

    AN ENDURANT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A FUSIFORM ABDOMINAL AORTIC ANEURYSM. THE PROXIMAL NECK WAS 29 MM IN DIAMETER AND 10 MM IN LENGTH AND ANGULATED. IT WAS REPORTED THAT THE ENDURANT STENT GRAFTS WERE SUCCESSFULLY IMPLANTED. A GORE LIMB WAS ALSO SUCCESSFULLY IMPLANTED. ON FINAL ANGIOGRAM A PROXIMAL TYPE I ENDOLEAK WAS OBSERVED. THE PHYSICIAN PERFORMED TOUCH UP WITH AN EQUALIZER BALLOON; HOWEVER, THE ENDOLEAK DID NOT RESOLVE. THE PATIENT WILL BE MONITORED BY THEIR PHYSICIAN. THE PHYSICIAN THINKS THE ENDOLEAK WILL RESOLVE WITH TIME. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01115029

    Patients

    Seq Age Sex Outcome Treatment
    1