BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE® TAG® THORACIC ENDOPROSTHESIS

    MDR report key: 5026061 · Received August 24, 2015

    Report

    Report Number
    2017233-2015-00549
    Event Type
    Death
    Date Received
    August 24, 2015
    Date of Event
    October 7, 2010
    Report Date
    July 4, 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

    ADDITIONAL MANUFACTURING NARRATIVE -THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.(B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON 7/4/2016.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THIS PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE USING A GORE TAG THORACIC ENDOPROSTHESIS (TGT3420/8141187) TO REPAIR A 64 MM THORACIC AORTIC ANEURYSM. ON UNKNOWN DATES, SURGICAL GRAFT REPAIR OF THE DESCENDING THORACIC AORTA, SURGICAL GRAFT REPAIR OF AN ABDOMINAL AORTIC ANEURYSM AND SURGICAL GRAFT REPLACEMENT OF THE AORTIC ARCH WAS PERFORMED. PRIOR TO DEVICE IMPLANT AN AXILLO-AXILLARY BYPASS WAS PERFORMED. THE DEVICE WAS INSERTED FROM THE RIGHT LEG OF THE SURGICAL GRAFT IN THE ABDOMINAL AORTA, AND DEPLOYED BETWEEN THE SURGICAL GRAFT OF THE AORTIC ARCH AND THE DESCENDING AORTA WITH NO REPORTED ISSUES. INTRAPROCEDURE ANGIOGRAPHY SHOWED A PROXIMAL TYPE I ENDOLEAK, WHICH WAS REPAIRED BY IMPLANTING A BARE METAL STENT WITHIN THE PROXIMAL NECK TO OBTAIN MORE NECK SEALING. FINAL ANGIOGRAPHY REVEALED THAT THE ENDOLEAK PERSISTED, AND THE PHYSICIAN ELECTED TO MONITOR THE PATIENT. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2010, FOLLOW-UP IMAGING SHOWED THAT THE ENDOLEAK PERSISTED, AND THE PHYSICIAN ELECTED TO MONITOR THE PATIENT. ON THE SAME DAY THE PATIENT WAS DISCHARGED. ON (B)(6) 2010, THE PATIENT PRESENTED WITH HEMOPTYSIS AND THEN EXPIRED. IT WAS REPORTED THAT THE HEMOPTYSIS WAS PROCEDURE-RELATED. NO FURTHER INFORMATION HAS BEEN RECEIVED.

    Description of Event or Problem · 1

    ON UNKNOWN DATES, SURGICAL GRAFT REPAIR OF THE DESCENDING THORACIC AORTA, SURGICAL GRAFT REPAIR OF AN ABDOMINAL AORTIC ANEURYSM AND SURGICAL GRAFT REPLACEMENT OF THE AORTIC ARCH WAS PERFORMED. ON (B)(6) 2010, THIS PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE USING A GORE TAG THORACIC ENDOPROSTHESIS TO REPAIR A 64 MM THORACIC AORTIC ANEURYSM. PRIOR TO DEVICE IMPLANT AN AXILLO-AXILLARY BYPASS WAS PERFORMED. THE DEVICE WAS INSERTED FROM THE RIGHT LEG OF THE SURGICAL GRAFT IN THE ABDOMINAL AORTA, AND DEPLOYED BETWEEN THE SURGICAL GRAFT OF THE AORTIC ARCH AND THE DESCENDING AORTA WITH NO REPORTED ISSUES. INTRAPROCEDURE ANGIOGRAPHY SHOWED A PROXIMAL TYPE I ENDOLEAK, WHICH WAS REPAIRED BY IMPLANTING A BARE METAL STENT WITHIN THE PROXIMAL NECK TO OBTAIN MORE NECK SEALING. FINAL ANGIOGRAPHY REVEALED THAT THE ENDOLEAK PERSISTED, AND THE PHYSICIAN ELECTED TO MONITOR THE PATIENT. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2010, FOLLOW-UP IMAGING SHOWED THAT THE ENDOLEAK PERSISTED, AND THE PHYSICIAN ELECTED TO MONITOR THE PATIENT. THE PATIENT PRESENTED WITH BLOOD-TINGED SPUTUM, BUT HIS CONDITION WAS STABLE. ON THE SAME DAY THE PATIENT WAS DISCHARGED. ON (B)(6) 2010, THE PATIENT PRESENTED WITH THE ANEURYSM RUPTURE DUE TO THE PERSISTENT ENDOLEAK, AND WAS TAKEN TO ANOTHER FACILITY. A SURGICAL PROCEDURE WAS CONSIDERED TO REPAIR THE RUPTURE SINCE IT WAS THE ONLY OPTION; HOWEVER THE PATIENT WAS NOT BEARABLE FOR SURGERY. ON THE SAME DAY THE PATIENT EXPIRED. IT WAS UNKNOWN IF AORTOBRONCHIAL FISTULA WAS DEVELOPED, OR AUTOPSY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559088 GORE® TAG® THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 8141187

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death