BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 2893406 · Received December 21, 2012

    Report

    Report Number
    2017233-2012-00861
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    November 1, 2011
    Report Date
    November 26, 2012
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THESE LOTS MET ALL PRE-RELEASE SPECIFICATIONS. ADDITIONAL DEVICES IMPLANTED AND/OR RELATE TO THIS EVENT: (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2010, THIS PT WAS IMPLANTED WITH TWO GORE TAG THORACIC ENDOPROSTHESES TO TREAT A LEAK FROM A PREVIOUS HEMASHIELD (PRE-COVERED STENTING) USED TO REPAIR AN AORTIC COARCTATION. THE SAME DAY THE PHYSICIAN REPORTEDLY PERFORMED A PLANNED COMMON CAROTID TO SUBCLAVIAN BYPASS AND LIGATION OF THE PROXIMAL LEFT SUBCLAVIAN ARTERY. THIS RESOLVED THE LEAK AND THE PT TOLERATED THE PROCEDURE. IT WAS REPORTED ON (B)(6) /2011, THE PT BECAME SEPTIC; THE PHYSICIAN REINTERVENED AND "CLEANED OUT" THE ENTIRE AREA OF THE DESCENDING THORACIC AORTA, AND EXPLANTED THE GORE TAG DEVICES AND THE HEMASHIELD AND THEN PERFORMED A SURGICAL CONVERSION. THE PT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE TAG THORACIC ENDOPROSTHESIS MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 06018595

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization| R FISH OIL| ASPIRIN| GLUCOSAMINE| RETIN A| CITALOPRAM| METORPORAL| MULTI VITAMINS| ZANTAC| AMILORIDE