BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX

    MDR report key: 3052459 · Received April 11, 2013

    Report

    Report Number
    2953200-2013-00661
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 15, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: STENT GRAFT MIGRATION, ENDOLEAK. AORTIC NECK DILATATION AND DISEASE PROGRESSION. CONCLUSION: AORTIC NECK DILATATION AND DISEASE PROGRESSION.

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY FROM THE TIME OF IMPLANT ARE UNKNOWN. THERE HAVE BEEN NO COMPLICATIONS SINCE THE TIME OF IMPLANT. IT WAS REPORTED THAT THE PATIENT HAD BEEN LOST TO FOLLOW-UP AND PRESENTED EMERGENTLY AT THE HOSPITAL APPROXIMATELY THREE WEEKS AGO. THE SUPRARENAL AORTA HAD GROWN RESULTING IN DEVICE MIGRATION WITH A TYPE I ENDOLEAK PRESENT. THE DECISION WAS MADE TO EXPLANT THE STENT GRAFTS. A CONVENTION TUBE GRAFT WAS SUCCESSFULLY IMPLANTED. THE EXPLANTED STENT GRAFTS WERE DISCARDED BY THE USER FACILITY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156758 ANEURX SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA M01F553180

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Required Intervention