BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® TAG® THORACIC ENDOPROSTHESIS

    MDR report key: 4852301 · Received June 17, 2015

    Report

    Report Number
    2017233-2015-00368
    Event Type
    Injury
    Date Received
    June 17, 2015
    Date of Event
    June 17, 2011
    Report Date
    August 13, 2015
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE - (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE - THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. USERS ARE MADE AWARE OF THE RISKS ASSOCIATED WITH TYPE II ENDOLEAKS IN THE IFU 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, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A THORACIC AORTIC ANEURYSM USING A GORE® TAG® THORACIC ENDOPROSTHESIS (TGT4015/8163386), AND ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS (PXT281412/8345729, PXC141200/8160753, PXC201000/8362661, PXC201400/8312411, AND PXA280300/8174727) SIMULTANEOUSLY. DURING THE PROCEDURE A BARE METAL STENT WAS IMPLANTED IN THE RIGHT RENAL ARTERY. IT WAS REPORTED THAT THE PATIENT LOST 1,540ML OF BLOOD DURING THE PROCEDURE; HOWEVER IT IS UNKNOWN WHICH SPECIFIC PROCEDURE CAUSED THE BLOOD LOSS. NO OTHER ISSUES WERE REPORTED. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2010, THE PATIENT WAS DISCHARGED. ON (B)(6) 2011, ONE MONTH FOLLOW-UP EXAMINATION SHOWED NO ISSUES WITH THE DIAMETER OF THE THORACIC AORTIC ANEURYSM MEASURING 45 MM. ON (B)(6) 2011, SIX MONTH FOLLOW-UP EXAMINATION REVEALED THAT THE THORACIC AORTIC ANEURYSM MEASURED 51 MM. THE PHYSICIAN ELECTED TO MONITOR THE PATIENT. ON (B)(6) 2011, ONE YEAR FOLLOW-UP EXAMINATION REVEALED A TYPE II ENDOLEAK OF UNKNOWN ORIGIN WITH THE DIAMETER OF THE THORACIC AORTIC ANEURYSM MEASURING 50 MM. THE PHYSICIAN ELECTED TO MONITOR THE PATIENT. THE PATIENT WAS LOST TO FOLLOW-UP, THEREFORE NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395535 GORE® TAG® THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 8163386

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other