BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX ADVANTAGE BIFURCATED STENT GRAFT - HYDRO

    MDR report key: 6174501 · Received December 14, 2016

    Report

    Report Number
    2953200-2016-02119
    Event Type
    Injury
    Date Received
    December 14, 2016
    Date of Event
    December 9, 2016
    Report Date
    December 9, 2016
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: SEX, DATE OF BIRTH. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    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 ANUERX STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5.8 CM ABDOMINAL AORTIC ANEURYSM. AT THE TIME OF INTERVENTION THE DIAMETER OF THE AORTA AT THE RENAL ARTERIES WAS 5.6MM X 5.8MM. THE LENGTH OF THE PROXIMAL NECK WAS 10MM. THE DEGREE OF ANGULATION WAS NOTED AS NONE TO MILD. IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE EMERGENCY ROOM WITH SEVERE BACK PAIN. A CT AND ANGIOGRAM REVEALED THAT THERE WAS A MIGRATION OF THE STENT GRAFT WITH A TYPE IA ENDOLEAK. THE PHYSICIAN STATED THAT THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. TWO 28X28X49 ENDURANT CUFFS WERE IMPLANTED AND THE ENDOLEAK RESOLVED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823702 ANEURX ADVANTAGE BIFURCATED STENT GRAFT - HYDRO SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR BFXCH2414135

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention