BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 3122521 · Received May 16, 2013

    Report

    Report Number
    2017233-2013-00313
    Event Type
    Injury
    Date Received
    May 16, 2013
    Date of Event
    August 3, 2009
    Report Date
    April 17, 2013
    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

    A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE(S) VERIFIED THAT THE LOT(S) MET ALL PRE-RELEASE SPECIFICATIONS. ACCORDING TO THE GORE TAG THORACIC ENDOPROSTHESIS INSTRUCTIONS FOR USE, STATES THE GORE TAG THORACIC ENDOPROSTHESIS IS INTENDED FOR ENDOVASCULAR REPAIR OF ANEURYSMS OF THE DESCENDING THORACIC AORTA. THE GORE TAG THORACIC ENDOPROSTHESIS IS DESIGNED TO TREAT PROXIMAL AND DISTAL AORTIC NECK LENGTHS NO LESS THAN 20 MM DISTAL TO EITHER THE LEFT SUBCLAVIAN OR LEFT COMMON CAROTID ARTERY WITH A REQUIRED MINIMUM 20 MM HEALTHY PROXIMAL AND DISTAL NECK LENGTHS. THE GORE TAG THORACIC ENDOPROSTHESIS. INSTRUCTIONS FOR USE (IFU) STATES: COMPLICATIONS ASSOCIATED WITH THE USE OF THE GORE TAG THORACIC ENDOPROSTHESIS MAY INCLUDE BUT ARE NOT LIMITED TO: ENDOLEAK.

    Description of Event or Problem · 1

    ON (B)(6) 2009, THIS PT UNDERWENT ENDOVASCULAR REPAIR FOR TREATMENT OF A THORACIC AORTIC ANEURYSM AND WAS IMPLANTED WITH TWO GORE TAG THORACIC ENDOPROSTHESES. THE PT TOLERATED THE PROCEDURE WITH NO EVIDENCE OF ENDOLEAK. ON (B)(6) 2009, IMAGING REVEALED A PROXIMAL TYPE I ENDOLEAK. ON (B)(6) 2009, THE PT UNDERWENT RE-INTERVENTION AND A HANDMADE STENT GRAFT WAS PLACED PROXIMALLY AND THE ENDOLEAK RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216867 GORE TAG THORACIC ENDOPROSTHESIS MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 06608440

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| O| R