BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE® TAG® THORACIC ENDOPROSTHESIS

    MDR report key: 5059777 · Received September 7, 2015

    Report

    Report Number
    2017233-2015-00588
    Event Type
    Death
    Date Received
    September 7, 2015
    Date of Event
    August 26, 2015
    Report Date
    August 26, 2015
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), COMPLICATIONS ASSOCIATED WITH THE USE OF THE CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS INSTRUCTIONS MAY INCLUDE BUT ARE NOT LIMITED TO AORTIC RUPTURE AND DEATH. MANUFACTURING EVALUATION PERFORMED. A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    IN 2014, THE PATIENT UNDERWENT AN OPEN ASCENDING AORTA AND AORTIC ARCH REPLACEMENT WITH A VASCULAR GRAFT TO REPAIR A TYPE A AORTIC DISSECTION THAT EXTENDED TO DESCENDING THORACIC AORTA. ON (B)(6) 2015, THE PATIENT UNDERWENT AN ENDOVASCULAR REPAIR OF THE REMAINING DISSECTION IN DESCENDING THORACIC AORTA USING TWO CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES ((B)(4) PROXIMAL AND (B)(4) DISTAL). AFTER THE SUCCESSFUL IMPLANTATION OF THE DEVICES, TOUCH-UP BALLOONING USING A CODA BALLOON WAS PERFORMED ON THE PROXIMAL NECK AND THE DEVICE JUNCTION AREA. NO ENDOLEAK WAS IDENTIFIED, AND THE PROCEDURE WAS COMPLETED WITH NO COMPLICATIONS. ON (B)(6) 2015, A RUPTURE OF THE FALSE LUMEN WAS IDENTIFIED. THE PATIENT EXPIRED ON THE SAME DAY FROM THE RUPTURE. THE PHYSICIAN REPORTEDLY SUSPECTED THAT THE AORTIC WALL WAS DAMAGED AT THE ANASTOMOTIC SITE OF THE VASCULAR GRAFT DUE TO BALLOONING OF THE PROXIMAL NECK, WHICH LED TO THE FALSE LUMEN PERFUSION AND THE RUPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590813 GORE® TAG® THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 13951149

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death| L