BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2969010 · Received February 12, 2013

    Report

    Report Number
    2953161-2013-00024
    Event Type
    Injury
    Date Received
    February 12, 2013
    Date of Event
    December 4, 2012
    Report Date
    January 16, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L EXCLUDER COMPONENTS INCLUDED IN THIS REPORT: RMT281416 / 10288234, PXC141000 / 9792580. A REVIEW OF THE MFG RECORDS FOR THE DEVICES VERIFIED THAT THE LOTS MET ALL PRE-RELEASE SPECIFICATIONS. PER THE GORE EXCLUDER AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO ENDOLEAK. THE PHYSICIAN AND PT SHOULD REVIEW THE RISKS AND BENEFITS WHEN DISCUSSING THIS ENDOVASCULAR DEVICE AND PROCEDURE INCLUDING THE POSSIBILITY THAT SUBSEQUENT INTERVENTIONAL OR OPEN SURGICAL REPAIR OF THE ANEURYSM MAY BE REQUIRED AFTER INITIAL ENDOVASCULAR REPAIR.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PT WAS IMPLANTED WITH THREE GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2012, COMPUTED TOMOGRAPHY SCAN REVEALED A PROXIMAL TYPE I ENDOLEAK, AND A DISTAL TYPE I ENDOLEAK IN THE RIGHT COMMON ILIAC ARTERY. ON THE SAME DAY, THE PT WAS IMPLANTED WITH AN AORTIC EXTENDER COMPONENT AND A CONTRALATERAL LEG COMPONENT TO TREAT THE PROXIMAL AND DISTAL ENDOLEAK, RESPECTIVELY. THE ENDOLEAKS WERE RESOLVED, AND THE PT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61966 GORE EXCLUDER AAA ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 10353516

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R VENTOLIN| SYMBICORT| LISINOPRIL| TYLENOL| SPIRIVA| FUROSEMIDE| VITAMIN B-1| B-COMPLEX TAB| CARDIZEM| FLOMAX| PROTONIX| ASPIRIN| HYDROCHLOROTHIAZIDE| VIAGRA| LIPITOR| COLASE| PRAZOLAM| PERCOCET| SEROQUEL