BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX STENT GRAFT SYSTEM

    MDR report key: 2853132 · Received November 30, 2012

    Report

    Report Number
    2953200-2012-02299
    Event Type
    Injury
    Date Received
    November 30, 2012
    Date of Event
    October 5, 2012
    Report Date
    November 1, 2012
    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: INHERENT RISK OF PROCEDURE (ENDOLEAK); PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (DISEASE PROGRESSION). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (DISEASE PROGRESSION).

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEMS WAS IMPLANTED IN A PATIENT FOR ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. THE ANEURYSM A ND VESSEL MORPHOLOGY FROM THE TIME OF IMPLANT WERE NOT REPORTED. THE ANEURYSM AND VESSEL MORPHOLOGY FROM ONE AGO WERE REPORTED AS THE FOLLOWING: THE ABDOMINAL AORTIC ANEURYSM IS 63.5-67.1 MM IN DIAMETER. VESSEL MORPHOLOGY WAS REPORTED TO AS PROXIMAL AORTA 26.2 MM IN DIAMETER AND 26 MM IN LENGTH. RIGHT ILIAC ARTERY WAS 23.1 MM IN DIAMETER. THE LEFT ILIAC ARTERY WAS 14.9 MM IN DIAMETER. THE RIGHT FEMORAL ARTERY WAS 10.1 MM IN DIAMETER AND THE LEFT FEMORAL ARTERIES WAS 9.5 MM IN DIAMETER. THE RIGHT COMMON ILIAC ARTERY WAS ANEURYSMAL WITH A DIAMETER OF APPROXIMATELY 14 MM. THE LEFT HYPOGASTRIC ARTERY HAD BEEN COILED AND WAS OCCLUDED. THE PATIENT CAME IN FOR A ROUTINE FOLLOW UP APPOINTMENT. IT WAS REPORTED THAT THERE WAS A DISTAL TYPE I ENDOLEAK AT THE END OF THE STENT AT THE LEFT ILIAC BIFURCATION. PREVIOUSLY A 24 MM AORTIC CUFF HAD BEEN DEPLOYED WITHIN THE MID ASPECT OF THE RIGHT COMMON ILIAC ARTERY. THE PHYSICIAN ELECTED TO IMPLANT A 28 X 28 MM ENDURANT AORTIC CUFF WITHIN THE RIGHT COMMON ILIAC ARTERY JUST PROXIMAL TO THE HYPOGASTRIC ARTERY. THERE WAS SOME DIFFICULTY REMOVING THE DELIVERY SYSTEM BECAUSE OF THE STRUTS OF THE CUFF. AT THE CONCLUSION OF THE PROCEDURE ANGIOGRAM WAS PERFORMED AND SHOWED GOOD FLOW THROUGH THE RIGHT ILIAC LIMB WITHOUT EVIDENCE OF AN ENDOLEAK. THE PHYSICIAN IMPLANTED A PALMAZ STENT PROXIMAL TO THE BIFURCATED STENT GRAFT AS A PROPHYLACTICALLY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA M03F551362

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Required Intervention