BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 5405885 · Received February 2, 2016

    Report

    Report Number
    2953161-2016-00016
    Event Type
    Injury
    Date Received
    February 2, 2016
    Date of Event
    October 21, 2010
    Report Date
    January 25, 2016
    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

    THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. (B)(4). REPORTABILITY OF PATIENT¿S DEATH THE PATIENT EXPIRED DUE TO MALNUTRITION AND WEAKNESS MORE THAN TWO YEARS POST INITIAL IMPLANT PROCEDURE. THESE EVENTS ARE NOT ATTRIBUTED TO THE DEVICE, AND IT IS DETERMINED THAT THIS PORTION OF EVENT IS NOT REPORTABLE.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A DISTAL AORTIC ARCH ANEURYSM USING TWO GORE® TAG® THORACIC ENDOPROSTHESES. PRIOR TO IMPLANTATION OF THE ENDOPROSTHESES, A GORE® EXCLUDER® AAA ENDOPROSTHESIS ILIAC EXTENDER COMPONENT (PXL161407/8233964) WAS DEPLOYED AS A CHIMNEY IN THE BRACHIOCEPHALIC ARTERY, AND A RIGHT SUBCLAVIAN-LEFT COMMON CAROTID-LEFT SUBCLAVIAN ARTERY BYPASS WAS PREPARED TO MAINTAIN BLOOD FLOW TO THE BRANCH VESSEL OF THE AORTIC ARCH. TWO ENDOPROSTHESES WERE THEN IMPLANTED. THE LEFT SUBCLAVIAN ARTERY WAS COIL-EMBOLIZED. INTRA-PROCEDURE IMAGING REVEALED A PROXIMAL TYPE I ENDOLEAK, AND THE PROCEDURE WAS CONCLUDED WITH A WAIT-AND-WATCH APPROACH TAKEN TO THE ENDOLEAK. ON (B)(6) 2010, A FOLLOW-UP REVEALED THAT THE PROXIMAL TYPE I ENDOLEAK PERSISTED. ANEURYSM DIAMETER WAS 66MM. ON (B)(6) 2010, THE PATIENT WAS DISCHARGED OF THE HOSPITAL. ON (B)(6) 2011, IN THREE-MONTH FOLLOW-UP STUDY, THE PROXIMAL TYPE I ENDOLEAK PERSISTED. ANEURYSM DIAMETER WAS 66MM. ON (B)(6) 2011, THE PATIENT WAS IMPLANTED WITH A STENT IN THE BRACHIOCEPHALIC ARTERY TO TREAT THE PROXIMAL TYPE I ENDOLEAK. ON (B)(6) 2011, IN SIX-MONTH FOLLOW-UP STUDY, THE PROXIMAL TYPE I ENDOLEAK STILL REMAINED. ANEURYSM DIAMETER WAS 66MM. ON (B)(6) 2011, THE PATIENT WAS IMPLANTED WITH AN ADDITIONAL GORE® TAG® THORACIC ENDOPROSTHESIS TO TREAT THE PROXIMAL TYPE I ENDOLEAK. ON (B)(6) 2011, IN ONE-YEAR FOLLOW-UP STUDY, THE PROXIMAL TYPE I ENDOLEAK STILL PERSISTED. ANEURYSM DIAMETER HAD ENLARGED TO 69MM. ON (B)(6) 2012, IN TWO-YEAR FOLLOW-UP STUDY, THE PROXIMAL TYPE I ENDOLEAK IS STILL PRESENT. FURTHER INTERVENTION WAS NOT PERFORMED. ANEURYSM DIAMETER WAS 68MM. ON (B)(6) 2012, THE PATIENT EXPIRED IN ANOTHER HOSPITAL DUE TO MALNUTRITION AND WEAKNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63019 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 8233964

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| R