BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 5270946 · Received December 7, 2015

    Report

    Report Number
    2017233-2015-00860
    Event Type
    Injury
    Date Received
    December 7, 2015
    Date of Event
    December 1, 2010
    Report Date
    November 9, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES (B)(6) 2010: PXC181000/8053043, TGT3420/8407159, TGT3420/8467329. THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2010, THIS PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE USING TWO GORE TAG THORACIC ENDOPROSTHESES (TGT3420/8407159, PROXIMAL, TGT3420/8467329, DISTAL) TO REPAIR AN AORTIC ARCH ANEURYSM. IT WAS PLANNED THAT THE DEVICES WOULD COVER THE THREE BRANCHES OF THE AORTIC ARCH, SO PRIOR TO THE DEVICE IMPLANT, BYPASS PROCEDURE TO THE LEFT COMMON CAROTID AND LEFT SUBCLAVIAN ARTERY WAS PERFORMED. DURING THE PROCEDURE, GORE EXCLUDER AAA ENDOPROSTHESIS CONTRALATERAL LEG COMPONENTS (PXC181000/8053038, PXC181000/8053043) WERE IMPLANTED AT THE BRACHIOCEPHALIC ARTERY AS A CHIMNEY TECHNIQUE. THE TOTAL AMOUNT OF BLOOD LOSS DURING THE WHOLE PROCEDURE WAS 600 ML; HOWEVER IT WAS UNKNOWN WHICH SPECIFIC PROCEDURE CAUSED THE LOSS. THE TAG DEVICES WERE IMPLANTED AT THE INTENDED POSITION WITH NO REPORTED ISSUES. AFTER THE PROCEDURE ON THE SAME DAY, THE PATIENT DEVELOPED A CEREBRAL INFARCTION. THE CAUSE OF THE INFARCTION WAS REPORTEDLY DEVICE-RELATED. IT WAS REPORTED THAT THE PHYSICIAN STARTED THE PATIENT ON REHABILITATION. ON (B)(6) 2011, POST-OPERATIVE FOLLOW-UP EXAMINATION SHOWED THAT THE CEREBRAL INFARCTION REMAINED. THE PHYSICIAN CONTINUED THE REHABILITATION. ON (B)(6) 2011, THE PATIENT DEVELOPED ANOTHER CEREBRAL INFARCTION, DISTINCT FROM THE ONE IDENTIFIED AFTER THE INITIAL TAG PROCEDURE. THE CAUSE OF THE INFARCTION WAS REPORTEDLY NOT DEVICE OR PROCEDURE RELATED. THE PHYSICIAN CONTINUED THE REHABILITATION. ON (B)(6) 2011, THE PATIENT EXPIRED DUE TO THE CEREBRAL INFARCTION DEVELOPED ON (B)(6) 2011. THE PATIENT'S DEATH WAS REPORTEDLY NOT DEVICE OR PROCEDURE RELATED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801057 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 8053038

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| O