BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II STENT GRAFT SYSTEM

    MDR report key: 2840868 · Received November 20, 2012

    Report

    Report Number
    2953200-2012-02253
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    October 26, 2012
    Report Date
    October 26, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK); LACK OF INFORMATION (CAUSE OF ENDOLEAK IS UNKNOWN). CONCLUSION: LACK OF INFORMATION (CAUSE OF ENDOLEAK IS UNKNOWN).

    Description of Event or Problem · 1

    AN ENDURANT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROXIMATELY THREE WEEKS AGO. THE PATIENT HAD A LONG AORTIC NECK AND THE REMAINDER OF THE VESSEL MORPHOLOGY WAS UNREMARKABLE. IT WAS REPORTED THAT THE FINAL ANGIOGRAM REVEALED A TYPE I ENDOLEAK. THE PHYSICIAN BALLOONED FOR A SECOND TIME AND THE ENDOLEAK DIMINISHED BUT DID NOT COMPLETELY RESOLVE. THE PHYSICIAN DECIDED TO NOT FURTHER INTERVENE. AN ANGIOGRAM WAS DONE AT THE TIME OF DISCHARGE AND THE ENDOLEAK WAS FOUND TO HAVE RESOLVED WITHOUT INTERVENTION. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT II STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01122386

    Patients

    Seq Age Sex Outcome Treatment
    1