BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® TAG® THORACIC ENDOPROSTHESIS

    MDR report key: 5453819 · Received February 23, 2016

    Report

    Report Number
    2017233-2016-00152
    Event Type
    Injury
    Date Received
    February 23, 2016
    Date of Event
    August 26, 2010
    Report Date
    January 25, 2016
    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

    THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. (B)(4). USERS ARE MADE AWARE OF THE RISKS ASSOCIATED WITH TYPE II ENDOLEAKS AND ARE INSTRUCTED TO CONSIDER THE RISKS AND BENEFITS DISCUSSED IN THE IFU FOR EACH PATIENT BEFORE USING THE DEVICES.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THIS PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE USING TWO GORE TAG THORACIC ENDOPROSTHESES (PROXIMAL: TGT3420/7777933, DISTAL: TGT4020/8030650) TO REPAIR A RUPTURED DISSECTED THORACIC AORTIC ANEURYSM OF 55 MM IN DIAMETER. IT WAS PLANNED THAT THE LEFT SUBCLAVIAN ARTERY WOULD BE COVERED BY THE DEVICE. AFTER SUCCESSFUL PLACEMENT OF THE ENDOPROSTHESES AT THE INTENDED POSITION AND INITIAL TOUCH-UP BALLOONING, INTRA-PROCEDURE ANGIOGRAPHY SHOWED AN INDETERMINATE ENDOLEAK. TOUCH-UP BALLOONING OF THE PROXIMAL NECK WAS PERFORMED AGAIN, AND THE LEFT SUBCLAVIAN ARTERY WAS COIL EMBOLIZED. FINAL ANGIOGRAPHY SHOWED RESOLUTION OF THE ENDOLEAK, AND THE PROCEDURE WAS CONCLUDED. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2010, ONE MONTH FOLLOW-UP IMAGING REVEALED A TYPE II ENDOLEAK OF UNKNOWN ORIGIN. THE PHYSICIAN ELECTED TO MONITOR THE PATIENT. THE DIAMETER OF THE ANEURYSM WAS 57 MM. ON (B)(6) 2010, THE PATIENT WAS DISCHARGED. ON (B)(6) 2011, SIX MONTH FOLLOW-UP IMAGING SHOWED THAT THE TYPE II ENDOLEAK REMAINED. THE DIAMETER OF THE ANEURYSM WAS 56 MM. ON (B)(6) 2012, ONE YEAR FOLLOW-UP IMAGING SHOWED THAT THE TYPE II ENDOLEAK REMAINED. THE DIAMETER OF THE ANEURYSM WAS 57 MM. ON (B)(6) 2013, THREE YEAR FOLLOW-UP IMAGING SHOWED THAT THE TYPE II ENDOLEAK REMAINED. THE DIAMETER OF THE ANEURYSM WAS 67 MM. THE PHYSICIAN ELECTED TO MONITOR THE PATIENT. ON (B)(6) 2014, FOUR YEAR FOLLOW-UP IMAGING WAS PERFORMED. IT WAS UNKNOWN WHETHER ANY ENDOLEAKS WERE PRESENT. A DIAMETER OF THE ANEURYSM WAS 59 MM. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110593 GORE® TAG® THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 7777933

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Other TGT4020/8030650