BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 12257958 · Received August 2, 2021

    Report

    Report Number
    3007284313-2021-01529
    Event Type
    Injury
    Date Received
    August 2, 2021
    Date of Event
    July 12, 2021
    Report Date
    August 2, 2021
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT SPECIFIC DETAILS HAVE BEEN PROVIDED. THEREFORE, THE PATIENT INITIALS REFLECT THE W. L. GORE INTERNAL CASE NUMBER. THE DATE OF INCIDENT IS UNKNOWN. THEREFORE, THE ONLINE PUBLICATION DATE OF THE LITERATURE ARTICLE IS USED AS DATE OF EVENT. REVIEW OF THE MANUFACTURING AND STERILIZATION RECORDS COULD NOT BE PERFORMED AS A VALID LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    THE LITERATURE ARTICLE: "LIMB GRAFT OCCLUSION FOLLOWING ENDOVASCULAR ANEURYSM REPAIR FOR INFRARENAL ABDOMINAL AORTIC ANEURYSM WITH THE ZENITH ALPHA, EXCLUDER, AND ENDURANT DEVICES: A MULTICENTRE COHORT STUDY" PUBLISHED BY BOGDANOVIC M, STACKELBERG O, LINDSTRÖM D, ET AL. WAS REVIEWED. THE ARTICLE WAS MADE AVAILABLE ONLINE JUL 12, 2021, IN EUROPEAN JOURNAL OF VASCULAR & ENDOVASCULAR SURGERY. THE PAPER DISCUSSES HOW DIFFERENT ENDOGRAFT TYPES AFFECTS THE RISK OF LIMB GRAFT OCCLUSION (LGO). BETWEEN JANUARY 2012 AND DECEMBER 2018, 924 PATIENTS WERE INCLUDED IN THE STUDY WERE 152 WERE TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS. IN THIS GROUP, THE MAJORITY WERE MALE AND THE MEAN AGE WAS 75.4±8 YEARS. ONE PATIENT WITH THE GORE® EXCLUDER® AAA ENDOPROSTHESIS EXPERIENCED OCCLUSION AFTER ONE MONTH FOLLOWUP, CORRESPONDING TO A OVERALL INCIDENCE RATE OF LGO TO 0.7%. NO PATIENT SPECIFIC INFORMATION REGARDING THE REPORTED EVENTS AND INTERVENTIONS WAS PROVIDED IN THE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1157040 GORE EXCLUDER AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention