BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2920147 · Received January 8, 2013

    Report

    Report Number
    2953161-2013-00004
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    October 23, 2012
    Report Date
    December 13, 2012
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL EXCLUDER COMPONENT INCLUDED IN THIS REPORT PCC141000/022804602. RESULTS: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICES VERIFIED THAT THE LOTS MET ALL PRE-RELEASE SPECIFICATIONS. CONCLUSIONS: ANEURYSM GROWTH IN THE ABSENCE OF ENDOLEAK HAS BEEN DEFINED AS ENDOTENSION. ONE HYPOTHESIS FOR THE SOURCE OF ENDOTENSION IS THE TRANSMURAL MOVEMENT OF SEROUS FLUID ACROSS THE MATERIAL USED TO FABRICATE DEVICES USED TO TREAT THE AORTIC ABDOMINAL ANEURYSM. IN RESPONSE TO THIS ISSUE, GORE ELECTED IN 2004 TO PROVIDE A DESIGN ENHANCEMENT TO THE ORIGINAL GORE EXCLUDER BIFURCATED ENDOPROSTHESIS.

    Description of Event or Problem · 1

    ON (B)(6) 2003, THE PATIENT WAS IMPLANTED WITH TWO GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON AN UNKNOWN DATE, FOLLOW-UP IMAGING REVEALED CONTINUED EXPANSION OF THE ANEURYSM (FROM 6.1 TO 6.3 CM). NO EVIDENCE OF AN ENDOLEAK WAS DETECTED. ON (B)(6) 2012, THE PHYSICIAN EXPLANTED THE EXISTING STENT-GRAFT SYSTEM, AND SURGICALLY REPAIRED THE ANEURYSM. THE PATIENT TOLERATED THE PROCEDURE. THE EXPLANTED EXCLUDER DEVICES WERE DESTROYED AT THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10336 GORE EXCLUDER AAA ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES 030134503

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R ASPIRIN| VITAMIN B12| NORVASC| PRAVACHOL| TYLENOL WITH CODEINE| COUMADIN| ATENOLOL