BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 3330999 · Received August 29, 2013

    Report

    Report Number
    2017233-2013-00592
    Event Type
    Injury
    Date Received
    August 29, 2013
    Date of Event
    April 1, 2013
    Report Date
    August 14, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE LOT NUMBER AND PATIENT DETAILS ARE NOT AVAILABLE. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    IN REVIEW OF A PUBLISHED LITERATURE, THESE FINDINGS WERE NOTED. THE ARTICLE WAS PUBLISHED ANNALS OF VASCULAR SURGERY WITH THE TITLE: "ASSESSMENT OF RENAL FUNCTION BY MEANS OF CYSTATIN C FOLLOWING STANDARD AND FENESTRATED ENDOVASCULAR ANEURYSM REPAIR." AUTHORS WERE: MOHAMED F. ABDELHAMID, ROBERT S. DAVIES, RAJIV K. VOHRA, DONALD J. ADAM, AND ANDREW W. BRADBURY, BIRMINGHAM, UNITED KINGDOM. ARTICLE SUMMARY: THE GOAL OF THIS STUDY, THEREFORE, WAS TO COMPARE THE EFFICACY OF CYST C, SCR, AND EGFR AS MARKERS OF RENAL FUNCTION AFTER EVAR. ADDITIONAL INFORMATION: BETWEEN JULY 2008 AND APRIL 2009, 29 PATIENTS WERE INCLUDED IN THE STUDY (27 MALE AND 2 FEMALE) WITH A MEAN AGE OF 76.9 YEARS (RANGE 55-89 YEARS) UNDERGOING STANDARD (N=19) AND FENESTRATED (N=10) EVAR FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH A MEDIAN DIAMETER OF 6.2 CM. A TOTAL OF 23 PATIENTS HAD A ZENITH (COOK INC., (B)(4), USA) AND 6 HAD AN EXCLUDER (WL GORE INC., (B)(4) USA) ENDOGRAFT IMPLANTED. THREE PATIENTS REQUIRED REINTERVENTION FOR NEW ONSET CLAUDICATION AT 6 MONTHS BECAUSE OF GRAFT LIMB STENOSIS; 2 REQUIRED ANGIOPLASTY AND THE THIRD REQUIRED COMBINED COMMON FEMORAL ARTERY ENDARTERECTOMY AND ANGIOPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427399 GORE EXCLUDER AAA ENDOPROSTHESIS MIH W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization