BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 3143024 · Received May 23, 2013

    Report

    Report Number
    2017233-2013-00336
    Event Type
    Injury
    Date Received
    May 23, 2013
    Date of Event
    May 17, 2013
    Report Date
    May 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 MFG RECORDS FOR THE DEVICE IS BEING CONDUCTED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PT WAS IMPLANTED WITH A GORE TAG THORACIC ENDOPROSTHESIS TO TREAT A DESCENDING THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT THE PHYSICIAN HAD DIFFICULTIES ADVANCING A GORE DRYSEAL SHEATH. IT WAS REPORTED THAT SINCE THERE WAS NO RESISTANCE WHEN THE DILATOR WAS ADVANCED, THE PHYSICIAN DECIDED INSERTING THE DELIVERY CATHETER OF THE GORE TAG THORACIC ENDOPROSTHESIS WITHOUT THE INTRODUCER SHEATH. ALSO, THE PHYSICIAN ACKNOWLEDGED THAT THE SHEATH ACCESS WAS DIFFICULT SINCE THE ACCESS VESSEL WAS 6-7.5MM DIAMETER WHILE THE OUTER DIAMETER OF THE SHEATH WAS 7.5MM. IT WAS REPORTED THERE WAS SOME RESISTANCE FELT WHEN THE DELIVERY CATHETER WAS ADVANCED AS WELL AS WITHDRAWN. AFTER THE DEVICE WAS DEPLOYED AND THE CATHETER WAS BEING WITHDRAWN, THE PHYSICIAN NOTICED A PIECE OF INTIMA ON IT'S DISTAL PORTION. AN ANGIOGRAPHY REVEALED A RUPTURE OF THE LEFT EXTERNAL ILIAC ARTERY. A METALLIC STENT WAS IMPLANTED TO REPAIR THE TRAUMA. FINAL IMAGING SHOWED EXCLUSION OF THE RUPTURE. THE PT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228084 GORE TAG THORACIC ENDOPROSTHESIS MIH W.L. GORE & ASSOCIATES 8733000

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization| R