BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II STENT GRAFT SYSTEM

    MDR report key: 2821638 · Received November 6, 2012

    Report

    Report Number
    2953200-2012-02128
    Event Type
    Injury
    Date Received
    November 6, 2012
    Date of Event
    October 10, 2012
    Report Date
    October 10, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK). PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (ANATOMY RELATED; SEVERELY ANGULATED AORTIC NECK). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (ANATOMY RELATED; SEVERELY ANGULATED AORTIC NECK).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE EMERGENT ENDOVASCULAR TREATMENT OF A 7.4 CM DIAMETER ABDOMINAL AORTIC ANEURYSM. THE AORTIC NECK WAS 18 MM IN LENGTH AND MEASURED 27 MM IN DIAMETER PROXIMALLY AND 30 MM DISTALLY AND IT WAS SEVERELY ANGULATED WITH MODERATE THROMBUS. THE STENT GRAFT WAS SUCCESSFULLY IMPLANTED AND MODELED THE PROXIMAL AREA OF THE STENT GRAFT WITH A BALLOON SEVERAL TIMES, BUT ON FINAL IMAGING THE PATIENT HAD SMALL PROXIMAL TYPE I ENDOLEAK. THE PATIENT'S CREATININE LEVEL WAS 1.9 BEFORE THE CASE AND THE PHYSICIAN DID NOT WANT TO USE ANYMORE CONTRAST AT THIS TIME. THE PHYSICIAN WILL MONITOR THE PATIENT. 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 V01696345

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR