BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 2903605 · Received January 3, 2013

    Report

    Report Number
    2017233-2013-00005
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    November 21, 2012
    Report Date
    December 11, 2012
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECS.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PT UNDERWENT TREATMENT OF A THORACIC AORTIC ANEURYSM WITH TWO CONFORMABLE GORE TAG THORACIC ENDOPROSTHESES. ON (B)(6) 2012, THE PT PRESENTED TO THE HOSPITAL WITH SEVERE BACK PAIN. FOLLOW-UP IMAGING REPORTEDLY SHOWED AN INFECTION IN THE THORACIC AORTIC ANEURYSM WITH TWO PSEUDOANEURYSMS ON BOTH SIDES OF THE AORTA AND EVIDENCE OF ANEURYSM ENLARGEMENT (AMOUNT UNKNOWN). IT WAS REPORTED THAT THE ANEURYSM ORIGINALLY REPAIRED DID NOT SHOW EVIDENCE OF ENLARGEMENT, BUT THERE WAS DILATATION OF THE AORTA AT THE PROXIMAL AND DISTAL ENDS OF THE DEVICES; HOWEVER, IT IS UNKNOWN WHAT CAUSED THE INFECTION OR PSEUDOANEURYSMS. ON (B)(6) 2012, AN ADDITIONAL PROCEDURE WAS PERFORMED WHEREBY THE CTAG DEVICES WERE EXPLANTED, AND THE AORTA WAS SURGICALLY REPAIRED WITH A GRAFT SOAKED IN ANTIBIOTICS. THE PT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3620 GORE TAG THORACIC ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 10065771

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R (B)(4)