BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 4870158 · Received June 25, 2015

    Report

    Report Number
    2953161-2015-00070
    Event Type
    Injury
    Date Received
    June 25, 2015
    Date of Event
    February 28, 2011
    Report Date
    August 14, 2015
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. CONCOMITANT PRODUCTS: (B)(6) 2011: PXA230300/8671871, PXA230300/8647334, PXA230300/8647332, TGT2610/8712860.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2011, THIS PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE USING A GORE® TAG® THORACIC ENDOPROSTHESIS (TGT2610/8712860) AND FOUR GORE® EXCLUDER® AAA ENDOPROSTHESIS AORTIC EXTENDER COMPONENTS, AND ONE GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEG COMPONENT TO REPAIR A DISSECTED THORACIC AORTIC ANEURYSM WITH DIAMETER OF 60 MM. IT WAS REPORTED THAT THE GORE® TAG® THORACIC ENDOPROSTHESIS WAS IMPLANTED MOST PROXIMALLY, AND FOUR GORE® EXCLUDER® AAA ENDOPROSTHESIS AORTIC EXTENDER COMPONENTS (PXA230300/8637117, PXA230300/8671871, PXA230300/8647334, AND PXA230300/8647332) WERE IMPLANTED DISTALLY TO THE TAG® DEVICE. A STENT GRAFT OF ANOTHER MANUFACTURER WAS THEN IMPLANTED DISTALLY TO THE AORTIC EXTENDER COMPONENTS, AND THEN THAT STENT GRAFT WAS EXTENDED DISTALLY WITH ONE GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEG COMPONENT (PXC161200/7129995). THE FINAL ANGIOGRAPHY REVEALED A TYPE III ENDOLEAK (DETAIL UNKNOWN), AND THE PHYSICIAN ELECTED TO MONITOR THE PATIENT. ON (B)(6) 2011, A ONE MONTH FOLLOW-UP EXAMINATION SHOWED THAT THE ENDOLEAK PERSISTED, AND THAT THE ANEURYSM MEASURED 65 MM. THE PHYSICIAN ELECTED TO MONITOR THE PATIENT. ON (B)(6) 2011, THE PATIENT WAS DISCHARGED. SUBSEQUENT FOLLOW-UP EXAMINATIONS SHOWED THAT THE ENDOLEAK PERSISTED, WITH THE ANEURYSM SHRINKING TO 40 MM. ON (B)(6) 2014, THE PATIENT COMPLAINED OF BACK PAIN AND WAS EMERGENTLY TRANSFERRED TO THE FACILITY. DOXAZOCIN WAS ADMINISTERED AND THE PAIN WAS RESOLVED. ON (B)(6) 2014, THREE YEAR FOLLOW-UP EXAMINATION SHOWED THAT THE ENDOLEAK PERSISTED, AND THAT THE ANEURYSM MEASURED 65 MM. THE PHYSICIAN ELECTED TO MONITOR THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412197 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 8637117

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other