BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 2655726 · Received July 3, 2012

    Report

    Report Number
    2017233-2012-00444
    Event Type
    Injury
    Date Received
    July 3, 2012
    Date of Event
    August 1, 2007
    Report Date
    June 14, 2012
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION - THE ROOT CAUSE OF THE GRAFT ERODING THE PREVIOUSLY PLACED DACRON GRAFT IS UNK. FEHRENBACHER, JOHN W AND ROBERT A MCCREADY. "EROSION OF ELEPHANT TRUNK DACRON GRAFT LIMB BY THORACIC ENDOGRAFT CAUSING ACUTE ANEURYSM EXPANSION." JOURNAL OF VASCULAR SURGERY 2009, 49: 491-3.

    Description of Event or Problem · 1

    AN ARTICLE IN THE JOURNAL OF VASCULAR SURGERY REPORTS A PT WHO WAS IMPLANTED WITH TWO GORE TAG THORACIC ENDOPROSTHESES TO REPAIR A DESCENDING THORACIC AORTIC ANEURYSM AS THE SECOND STAGE OF A HYBRID PROCEDURE. THE PT HAD PREVIOUSLY UNDERGONE REPAIR OF ASCENDING AND AORTIC ARCH ANEURYSMS, WITH AN ELEPHANT TRUNK GRAFT LIMB PLACED IN THE DESCENDING THORACIC AORTA. EIGHT MONTHS AFTER PLACEMENT OF THE THORACIC ENDOGRAFT, THE PT PRESENTED WITH AN ACUTELY EXPANDING AND SYMPTOMATIC THORACIC ANEURYSM. THE PT WAS OPERATED ON URGENTLY. THE PROXIMAL PORTION OF THE ENDOGRAFT HAD ERODED INTO THE PREVIOUSLY PLACED DACRON ELEPHANT TRUNK LIMB. THE PROXIMAL PORTION OF THE ENDOGRAFT WAS REMOVED AND WAS REPLACED WITH A DACRON GRAFT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| R