BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 3122505 · Received May 15, 2013

    Report

    Report Number
    2017233-2013-00309
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    March 26, 2013
    Report Date
    April 22, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REFER TO THE FOLLOWING MEDWATCH REPORT FOR THE INFORMATION REGARDING THE CONFORMABLE GORE TAG THORACIC ENDOPROSTHESIS: 2017233-2013-00310.

    Description of Event or Problem · 1

    ON AN UNKNOWN DATE IN 2005, THE PATIENT UNDERWENT TREATMENT OF A TYPE A DISSECTION USING AN ELEPHANT TRUNK TECHNIQUE. IT WAS REPORTED, THE DISSECTION EXTENDED DISTALLY INTO ONE OF THE EXTERNAL ILIAC ARTERIES. ON AN UNKNOWN DATE IN 2011, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM AND FALSE LUMEN REPERFUSION. A 31 MM GORE EXCLUDER AAA ENDOPROSTHESIS TRUNK-IPSILATERAL LEG COMPONENT WAS IMPLANTED WITH A 45 MM CONFORMABLE GORE TAG THORACIC ENDOPROSTHESIS EXTENDING PROXIMALLY. ON (B)(6) 2013, A FOLLOW-UP COMPUTED TOMOGRAPHY SCAN SHOWED FILLING OF THE FALSE LUMEN FROM PROXIMAL SEPTAL TEARS. IT WAS REPORTED, THE ANEURYSM WAS NOTED TO BE INCREASING IN SIZE AND MEASURED 6.2 CM. ON (B)(6) 2013, AN INTERVENTION WAS PERFORMED TO TREAT THE FALSE LUMEN PERFUSION OF THE ABDOMINAL AORTIC ANEURYSM. A CONFORMABLE GORE TAG DEVICE WAS IMPLANTED PROXIMALLY, AND A SECOND TAG DEVICE WAS PLACED DISTALLY FROM THE PROXIMAL ELEPHANT TRUNK TO THE ABDOMINAL STENT GRAFT AFTER COMPLETE VISCERAL DEBRANCHING. COMPLETION ANGIOGRAPHY SHOWED NO EVIDENCE OF ENDOLEAK, AND THE PATIENT TOLERATED THE PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214471 GORE EXCLUDER AAA ENDOPROSTHESIS MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R DIAZEPAM| METOPROLOL