BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 3027785 · Received March 20, 2013

    Report

    Report Number
    2017233-2013-00156
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 21, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL EXCLUDER COMPONENTS INCLUDED IN THIS REPORT: PXA280300/7071607, PXA280300/06487494, PLA320400/10910337. RESULTS - A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE WAS VERIFIED THAT THE LOTS MET ALL PRE-RELEASE SPECIFICATIONS. CONCLUSIONS - PER THE GORE EXCLUDER AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), KEY ANATOMIC ELEMENTS THAT MAY AFFECT SUCCESSFUL EXCLUSION OF THE ANEURYSM INCLUDE SEVER PROXIMAL NECK ANGULATION, SHORT PROXIMAL AORTIC NECK AND SIGNIFICANT THROMBUS AND/ OR CALCIUM AT THE ARTERIAL IMPLANTATION SITES, SPECIFICALLY THE PROXIMAL AORTIC NECK AND DISTAL ILIAC ARTERY INTERFACE.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PATIENT WAS IMPLANTED WITH A SYSTEM OF GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON AN UNKNOWN DATE, A THREE-YEAR FOLLOW-UP COMPUTED TOMOGRAPHY SCAN REVEALED AN ENDOLEAK. IT WAS UNCLEAR TO THE PHYSICIAN WHETHER THE LEAK WAS A PROXIMAL TYPE I, A TYPE III, OR BOTH. ON (B)(6) 2013, THE PATIENT WAS IMPLANTED WITH AN AORTIC EXTENDER COMPONENT AND A PALMAZ STENT TO TREAT THE PROXIMAL TYPE I ENDOLEAK. THE PHYSICIAN ALSO IMPLANTED AN ADDITIONAL PALMAZ STENT BETWEEN THE AORTIC EXTENDER AND THE EXISTING STENT GRAFT TO TREAT A POTENTIAL TYPE III ENDOLEAK. A FINAL ANGIOGRAPHIC RUN REPORTED DEMONSTRATED THAT THE ENDOLEAK(S) WAS IMPROVED, BUT NOT FULLY RESOLVED. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAD NOTABLY TORTUOUS ANATOMY, INCLUDING A SEVERELY ANGULATED INFRARENAL AORTIC NECK (GREATER THAN 60 DEGREES). THE PHYSICIAN INDICATED AORTIC REMODELING OVER TIME MAY HAVE BEEN A CONTRIBUTING FACTOR TO THE ENDOLEAK(S).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115296 GORE EXCLUDER AAA ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 8044609

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R NORVASC| LOPRESSOR| COUMADIN| ZOCOR| LANOXIN| CORDARONE| PRILOSEC| DIGOXIN| VASOTEC