BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 2921952 · Received January 11, 2013

    Report

    Report Number
    2017233-2013-00019
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    February 26, 2009
    Report Date
    December 14, 2012
    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

    PLEASE NOTE ADDITIONAL DEVICE RELATED TO THIS EVENT TG3715/06167140. A REVIEW OF THE MFG RECORDS FOR THE DEVICE(S) VERIFIED THAT THE LOT(S) MET ALL PRE-RELEASE SPECIFICATIONS. CODE - THE SAFETY AND EFFECTIVENESS OF THE GORE TAG THORACIC ENDOPROSTHESIS HAS NOT BEEN EVALUATED IN THE FOLLOWING PT POPULATIONS: ACUTE AND CHRONIC DISSECTIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2009, UNDERWENT EMERGENT TREATMENT FOR A RUPTURE OF THE FALSE LUMEN OF A TYPE B DISSECTION. THE DISSECTION ORIGINATED AT THE LEFT SUBCLAVIAN ARTERY (LSA). TWO GORE TAG THORACIC ENDOPROSTHESIS WERE IMPLANTED, WHICH INCLUDED INTENTIONAL COVERAGE OF THE LSA AND A SUBCLAVIAN-SUBCLAVIAN BYPASS. AT THE CONCLUSION OF THE PROCEDURE, THE PT SUFFERED A CEREBRAL INFARCTION. THE PT TOLERATED THE PROCEDURE. THE PHYSICIAN DOES NOT BELIEVE THE DEVICES CAUSED OR CONTRIBUTED TO THE EVENT. ON (B)(6) 2009, THE PT RECEIVED DRUG TREATMENT. ON (B)(6) 2009, THE PT WAS DISCHARGED FROM THE HOSPITAL WITH SYMPTOMS REMAINING. THE PT DID NOT CONTINUE F/U CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17781 GORE TAG THORACIC ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 06394704

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization| O