BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2655595 · Received July 6, 2012

    Report

    Report Number
    2017233-2012-00461
    Event Type
    Injury
    Date Received
    July 6, 2012
    Date of Event
    April 5, 2012
    Report Date
    July 2, 2012
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBERS WERE REQUESTED AND NOT PROVIDED TO GORE. ADDITIONAL INFO WAS REQUESTED. THE ARTICLE "RETROGRADE HYPOGASTRIC ARTERY EMBOLIZATION TO TREAT ILIAC ARTERY ANEURYSMS GROWING AFTER AORTOILIAC REPAIR" JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY 2012;23(7):873-877 (SUSANNE ABDERHALDEN, MD, ZORAN RANCIC, MD, MARIO L. LACHAT, MD, AND THOMAS PFAMMATTER, MD). THE PUBLISHED DATE OF THE ARTICLE IS (B)(4) 2012. SINCE NO OTHER DATES ARE PROVIDED AS TO SPECIFIC ADVERSE EVENTS, THE DATE OF EVENT WILL BE (B)(6) 2012.

    Description of Event or Problem · 1

    IN REVIEW OF PUBLISHED LITERATURE, THESE FINDINGS WERE NOTED. THE ARTICLE DESCRIBES THAT A (B)(6) MAN WITH AN AORTOILIAC ANEURYSM (6.8CM AAA, 4.5-CM RIGHT CIAA, AND 3-CM LEFT CIAA) HAD BEEN TREATED BY A HYBRID PROCEDURE. ON THE LEFT, AN EXTERNAL-INTERNAL ILIAC BYPASS HAD BEEN PERFORMED TO PRESERVE THE INTERNAL ILIAC PERFUSION. ON THE RIGHT, THE INTERNAL ILIAC ARTERY HAD BEEN LIGATED BEFORE THE PLACEMENT OF A BIFURCATED AORTOILIAC ENDOPROSTHESIS WITH DISTAL ANCHORING IN THE EXTERNAL ILIAC ARTERIES (EXCLUDER AAA ENDOPROSTHESIS). CT ANGIOGRAPHY PERFORMED 5 MONTHS AFTER THE PROCEDURE SHOWED FURTHER AAA GROWTH WITH SAC REPERFUSION LIKELY SECONDARY TO THE INSUFFICIENCY OF THE LIGATURE OF THE INTERNAL ILIAC ARTERY AND A LUMBAR ARTERY ENDOLEAK. AN ANTEGRADE, IPSILATERAL COMMON FEMORAL ACCESS WAS CHOSEN TO ADVANCE A 4-F COBRA 1 CATHETER (GLIDECATH) AND A 3-F COAXIAL CATHETER (TRACKER; BOSTON SCIENTIFIC/TARGET, (B)(4)) VIA THE MEDIAL CIRCUMFLEX FEMORAL ARTERY INTO THE PROXIMAL OBTURATOR ARTERY, WHICH THE ONLY PATENT INTERNAL ILIAC ARTERY BRANCH. THE OBTURATOR ARTERY WAS OCCLUDED WITH THROMBIN (BERIPLAST P COMBI-SET; CSL (B)(4)) AND TWO FIBERED PLATINUM MICROCOILS (VORTX, 4 MM; BOSTON SCIENTIFIC). THROUGH THE 4-F MOTHER-CATHETER, EMBOLIZATION OF THE MEDIAL CIRCUMFLEX FEMORAL ARTERY WAS PERFORMED WITH A STANDARD MACROCOIL. DURING THE FOLLOW-UP PERIOD OF 102 MONTHS AFTER THIS PROCEDURE, THE DIAMETERS OF THE ANEURYSMS REMAINED UNCHANGED ON CT ANGIOGRAPHY DESPITE PERSISTENCE OF THE LUMBAR ARTERY TYPE II ENDOLEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR