BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 3143368 · Received May 24, 2013

    Report

    Report Number
    2017233-2013-00340
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    April 27, 2013
    Report Date
    April 28, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PT UNDERWENT TREATMENT OF A RUPTURED ABERRANT RIGHT SUBCLAVIAN ARTERY (RSA) AND RUPTURED KOMMERELL DIVERTICULUM WITH CONFORMABLE GORE TAG THORACIC ENDOPROSTHESES. IT WAS REPORTED, THE PT HAD A VERY DISEASED AORTA WITH MULTIPLE ANEURISMAL SECTIONS, AND THE ACCESS VESSELS WERE SMALLER THAN REQUIRED FOR THE 24FR DRYSEAL SHEATH NEEDED FOR THE TAG DEVICE. DUE TO THIS, THE SHEATH WAS NOT ADVANCED ALL THE WAY INTO THE AORTA, BUT WAS LEFT SHORT IN THE ILIAC ARTERY. AN ATTEMPT WAS MADE TO ADVANCE THE FIRST CTAG DEVICE UP TO THE LEFT COMMON CAROTID ARTERY (LCCA) FOR DEPLOYMENT. HOWEVER, IT WAS REPORTED THAT DUE TO THE PT'S EXTREMELY TORTUOUS ANATOMY, THE DEVICE WOULD NOT ADVANCE FURTHER THAN THE MID-DESCENDING AORTA. A DECISION WAS MADE TO REMOVE THE DEVICE. AS THE DEVICE WAS BEING WITHDRAWN WITH DIFFICULTY OUTSIDE OF THE SHEATH, THE DEVICE DEPLOYED IN THE AREA OF THE DISTAL AORTA, EXTENDING DOWN TO THE RIGHT COMMON AND EXTERNAL ILIAC ARTERIES AND COVERING THE RIGHT HYPOGASTRIC ARTERY. AT THIS POINT, A RETRO-PERITONEAL CUT DOWN ON THE DISTAL AORTA WAS PERFORMED TO REMOVE THE PREDEPLOYED DEVICE. A CONDUIT WAS THEN SEWN ONTO THE DISTAL AORTA TO ADVANCE THE REMAINING DEVICES. FOUR DEVICES WERE IMPLANTED FROM THE LCCA COVERING THE ANEURISMAL SECTION, AND SURGICAL PROCEDURES WERE COMPLETED TO BYPASS BOTH THE LSA AND RSA TO THE COMMON CAROTID ARTERIES. IT WAS REPORTED, THE ANEURYSM WAS SEALED AT THE END OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232315 GORE TAG THORACIC ENDOPROSTHESIS MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANUERYSM TREATMENT MIH W.L. GORE & ASSOCIATES 11207155

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R PT'S MEDICATIONS INCLUDE OXYGEN