BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC ANEURX BIFURCATED STENT GRAFT (FLEXIBLE)

    MDR report key: 1192568 · Received October 8, 2008

    Report

    Report Number
    2953200-2008-00904
    Event Type
    Injury
    Date Received
    October 8, 2008
    Date of Event
    September 16, 2008
    Report Date
    September 16, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: ENDOLEAK. CONCLUSION: STENT GRAFT NOT ADEQUATELY POSITIONED BELOW THE RENAL ARTERIES AND WITHIN THE ILIAC ARTERY. PATIENT CODE: OTHER (REQUIRED SECONDARY INTERVENTION).

    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 APPROXIMATELY 5 YEARS AGO. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WERE NOT REPORTED. IT WAS REPORTED THAT THERE IS A PROXIMAL TYPE 1 ENDOLEAK AND A DISTAL TYPE I ENDOLEAK AT THE RIGHT COMMON ILIAC ARTERY WITH THE STENT GRAFT LIMB UP IN THE ANEURYSM SAC. THE PROXIMAL PORTION OF THE STENT GRAFT WAS APPROXIMATELY 3 CM DISTAL TO THE RENAL ARTERIES AND CREATED A PROXIMAL TYPE 1 ENDOLEAK. IN A PRIOR STUDY TWO YEARS AGO, A NON-CONTRAST STUDY DEMONSTRATED THAT THERE WAS NO ENDOLEAK PRESENT; HOWEVER, THE PROXIMAL PORTION OF THE STENT GRAFT WAS AT APPROXIMATELY 3 CM BELOW THE RENAL ARTERIES AND THE RIGHT LIMB WAS BARELY IN THE RIGHT COMMON ILIAC ARTERY. FOR THE PROXIMAL TYPE 1 ENDOLEAK, THE DECISION WAS MADE TO USE A 30 MM TALENT AORTIC CUFF; HOWEVER, THE CATHETER WAS UNABLE TO PASS THROUGH THE LEFT COMMON ILIAC ARTERY, THEREFORE, A 28 MM CUFF WAS USED INSTEAD DUE TO IT'S SMALLER PASSING PROFILE. A 16 MM X 13.5 CM ILIAC LIMB AND A 16 MM X 5.5 CM ILIAC EXTENSION WERE IMPLANTED IN THE RIGHT AND LEFT COMMON ILIAC ARTERIES RESPECTIVELY FOR TREATMENT OF THE DISTAL TYPE 1 ENDOLEAK. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC ANEURX BIFURCATED STENT GRAFT (FLEXIBLE) MIH MEDTRONIC CARDIOVASCULAR NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention