BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 2903616 · Received January 3, 2013

    Report

    Report Number
    2017233-2013-00003
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    November 12, 2012
    Report Date
    December 6, 2012
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECS. THE ROOT CAUSE OF THE ENDOLEAK IS UNKNOWN. ADDITIONAL DEVICE IMPLANTED AND INVOLVED IN THIS EVENT: (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PT WAS IMPLANTED WITH TWO GORE TAG THORACIC ENDOPROSTHESES TO TREAT AN ACUTE COMPLICATED TYPE B DISSECTION. IT WAS REPORTED THAT THE DISSECTION WAS COMPLETELY EXCLUDED AT THE END OF THE PROCEDURE. AT A ONE-YEAR FOLLOW-UP IN (B)(6) 2011 (DATE UNKNOWN), FOLLOW-UP IMAGING IDENTIFIED A PROXIMAL TYPE I ENDOLEAK. ON (B)(6) 2012, FOLLOW-UP IMAGING CONFIRMED THE PRESENCE OF A PROXIMAL TYPE I ENDOLEAK WITH EVIDENCE OF A PSEUDOANEURYSM, FALSE LUMEN REPERFUSION, AND ANEURYSM ENLARGEMENT OF 4.5-5 CM. IT WAS REPORTED THAT THE ENDOLEAK WAS DUE TO THE DISSECTION, BUT IT IS REPORTEDLY UNKNOWN IF THE DISSECTION EXTENDED PROXIMALLY AFTER THE IMPLANT PROCEDURE. ON (B)(6) 2012, THE PT UNDERWENT A CAROTID-SUBCLAVIAN BYPASSING PROCEDURE AS THE FIRST PART OF A STAGED PROCEDURE. ON (B)(6) 2012, THE SECOND PART OF THE STAGE PROCEDURE WAS PERFORMED WHEREBY A CONFORMABLE GORE TAG THORACIC ENDOPROSTHESIS WAS IMPLANTED FOR PROXIMAL EXTENSION. IT WAS REPORTED THAT AP PROXIMAL TYPE I ENDOLEAK WAS AGAIN IDENTIFIED AFTER THE IMPLANT OF THE ADDITIONAL CTAG DEVICE. ADDITIONAL ANGIOPLASTY WAS PERFORMED, BUT IT IS UNKNOWN IF THE ENDOLEAK COMPLETELY RESOLVED. THE PROCEDURE WAS CONCLUDED AND THE PT TOLERATED THE PROCEDURE. NO FURTHER ADVERSE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2032 GORE TAG THORACIC ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 8017812

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R LISINOPRIL| CRESTOR| CATAPRES| ASPIRIN