BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT IIS BIFURCATED STENT GRAFT

    MDR report key: 6135508 · Received November 30, 2016

    Report

    Report Number
    2953200-2016-02042
    Event Type
    Malfunction
    Date Received
    November 30, 2016
    Date of Event
    November 1, 2016
    Report Date
    December 2, 2016
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: SEX, DATE OF BIRTH, NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    FILM EVALUATION SUMMARY: THE EXACT CAUSE OF THE POSSIBLE PROXIMAL TYPE I ENDOLEAK COULD NOT BE CONCLUSIVELY DETERMINED FROM THE CTA'S PROVIDED. THE FILMS AT IMPLANT WERE NOT PROVIDED. THE PRE- AND POST-IMPLANT CTA'S PROVIDED CONFIRMED THAT THE PROXIMAL AORTIC NECK WAS HEAVILY CALCIFIED. IT IS POSSIBLE THAT IMPLANTING THE STENT GRAFT IN THE HEAVILY CALCIFIED PROXIMAL AORTIC NECK MAY HAVE CONTRIBUTED TO THE PROXIMAL TYPE I ENDOLEAK. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5.6 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. THE PROXIMAL AORTIC NECK MEASURED 21 MM IN DIAMETER AT THE RENAL ARTERY AND MEASURED 1.8 CM IN LENGTH. THE PROXIMAL AORTIC NECK HAD 25 DEGREES OF ANGULATION. THE LEFT SIDE ACCESS VESSEL HAD A 90 DEGREE CURVE. THE RIGHT SIDE ACCESS VESSEL HAD MILD ANGULATION. THERE WAS MODERATE VESSEL CALCIFICATION. IT WAS REPORTED THAT APPROXIMATELY ONE MONTH POST INDEX PROCEDURE A CT REVEALED A PROXIMAL TYPE I ENDOLEAK. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS BEING MONITORED BY THEIR PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785442 ENDURANT IIS BIFURCATED STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND ESBF2514C103E

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR