BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS

    MDR report key: 6979610 · Received October 26, 2017

    Report

    Report Number
    2017233-2017-00559
    Event Type
    Injury
    Date Received
    October 26, 2017
    Date of Event
    April 19, 2017
    Report Date
    December 7, 2017
    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

    ADDITIONAL MANUFACTURER NARRATIVE/CORRECTED DATA - ATTACHED SOURCE ARTICLE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IN LITERATURE THE FOLLOWING INFORMATION WAS OBTAINED: (B)(6) JOURNAL VOL. 26. PAGE 51(APR 19, 2017). FROZEN ELEPHANT TRUNK TECHNIQUE REPORT OF CONFORMABLE GORE TAG THORACIC ENDOPROSTHESIS ON ASCENDING ARCH REPLACEMENT KAJIYAMA T, SATO N, MATSUE H, ISHIDA M, KO Y, MATSUDA A. FIFTEEN (15) PATIENTS WHO HAD BEEN IMPLANTED WITH CONFORMABLE GORE TAG THORACIC ENDOPROSTHESIS WITH FROZEN ELEPHANT TRUNK TECHNIQUE (TAR-FET) AND 13 PATIENTS WHO HAD BEEN IMPLANTED WITH ARTIFICIAL BLOOD VESSEL BY OPEN CHEST SURGERY (TAR-ET). THE PATIENT BACKGROUND AS FOLLOWS. MEAN AGE: TAR-FET 70.3+-13.3 TAR-ET 66.2+-17.7, THE RESULT IS AS FOLLOWS. OPERATION TIME: TAR-FET 533.5+-1.2 TAR-ET 502.8+-75.0, CPB TIME: TAR-FET 209.4+-57.1 MIN TAR-ET 284.2+-64.9 P<0.0016, BLOOD TRANSFUSION VOLUME: TAR-FET 1266.7+-474.4 ML TAR-ET 2929.2+-1013.5 P<0.0001, INTUBATION TIME: TAR-FET 69.9+-62.6HR TAR-ET 79.1+-47.6, ICU TIME: TAR-FET 8.3+-9.7 DAY TAR-ET 8.7+-9.7. REGARDING THE HEALTH HAZARD, 2 PATIENTS OF TAR-FET DIED DURING PROCEDURE AND 1 PATIENTS OF TAR-FET SUFFERED PARAPARESIS THOUGH, THE AUTHOR REPORTED THAT TAR-FET WAS CONSIDERED MORE BENEFICIAL THAN TAR-ET SINCE TAR-FET WAS LESS INVASIVE THERAPIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758627 CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability