BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2561337 · Received April 24, 2012

    Report

    Report Number
    2017233-2012-00270
    Event Type
    Injury
    Date Received
    April 24, 2012
    Date of Event
    April 5, 2012
    Report Date
    April 5, 2012
    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

    RESULTS - THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. CONCLUSIONS - PER THE GORE EXCLUDER AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE: THE GORE EXCLUDER AAA ENDOPROSTHESIS IS INTENDED TO EXCLUDE THE ANEURYSM FROM THE BLOOD CIRCULATION IN PATIENTS DIAGNOSED WITH INTRARENAL ABDOMINAL AORTIC ANEURYSM (AAA) DISEASE AND WHO HAVE APPROPRIATE ANATOMY.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN AORTIC ANEURYSM USING TWO GORE TAG THORACIC ENDOPROSTHESIS. IT WAS REPORTED THAT THE TAG DEVICES WERE PLACED FROM THE ASCENDING AORTA TO THE DISTAL ARCH TO TREAT THE ANEURYSM AT THE AORTIC ARCH. AND A CONTRALATERAL LEG WAS IMPLANTED TOGETHER TO DO THE CHIMNEY TECHNIQUE. ON THE SAME DAY, BEFORE THE PROCEDURE, DEBRANCHING SURGERY USING THE VASCULAR GRAFT FROM THE RIGHT SUBCLAVIAN TO THE LEFT SUBCLAVIAN AND THE LEFT COMMON CAROTID ARTERY WAS PERFORMED. AFTER THE CANNULATION OF THE PXC DELIVERY CATHETER FROM THE BRACHIOCEPHALIC TRUNK TO THE ASCENDING AORTA WAS DONE, TWO TAG DEVICES WERE DEPLOYED. THEN THE PXC WAS DEPLOYED TO KEEP THE BLOOD FLOW INTO BOTH CAROTID ARTERIES AND SUBCLAVIANS. ON (B)(6) 2012, FOLLOW-UP CT REVEALED TYPE A DISSECTION AROUND THE EDGE OF PXC. THE PHYSICIAN PERFORMED VASCULAR REPLACEMENT OF THE ASCENDING AORTA. PXC AND PROXIMAL TGT WERE PARTIALLY REMOVED AND ANASTOMOSED WITH THE VASCULAR GRAFT. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN STATED THAT AT THE TIME OF THE PXC BALLOONING, THE MOVING PXC MADE THE DISSECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS MIH/SYSTEM ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 9585253

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R