BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2951101 · Received February 8, 2013

    Report

    Report Number
    2953200-2013-00222
    Event Type
    Injury
    Date Received
    February 8, 2013
    Date of Event
    February 15, 2013
    Report Date
    March 5, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED AS FOLLOWS: IT WAS REPORTED THAT AN ENDURANT II 363670 AORTIC CUFF WAS IMPLANTED AND SUCCESSFULLY RESOLVED THE PROXIMAL TYPE I ENDOLEAK.

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5 CM ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 5 YEARS AGO. VESSEL MORPHOLOGY FROM THE TIME OF IMPLANT IS UNKNOWN. IT WAS REPORTED THAT DURING A ROUTINE FOLLOW-UP THE CT SCAN SHOWED THE ABDOMINAL AORTIC ANEURYSM HAD INCREASED TO 5.4 CM. THE BIFURCATED STENT GRAFT WAS 3.5 CM DISTAL TO THE RENAL ARTERIES AND THERE WAS A PROXIMAL TYPE I ENDOLEAK VISIBLE. THE AORTIC NECK MEASURED 27.5-31.5 MM IN DIAMETER JUST BELOW THE RENAL ARTERIES AND IT WAS 15 MM IN LENGTH. THE PATIENT WILL BE TREATED AT A LATER DATE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55028 ANEURX ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA V00066938

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR Required Intervention