BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE HEMOBAHN ENDOPROSTHESIS

    MDR report key: 1831959 · Received September 8, 2010

    Report

    Report Number
    2017233-2010-00395
    Event Type
    Injury
    Date Received
    September 8, 2010
    Date of Event
    June 15, 1998
    Report Date
    September 8, 2010
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    NIO
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HEMOBAHN DEVICE REMAINS IMPLANTED. THE INVESTIGATION INTO THIS EVENT IS IN PROCESS. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE PHYSICIAN.

    Description of Event or Problem · 1

    DURING REVIEW OF A CASE REPORT (LITERATURE) ON (B)(6) 2010, A POSSIBLE ADVERSE EVENT ASSOCIATED WITH THE USE OF A GORE HEMOBAHN DEVICE WAS IDENTIFIED: A (B)(6), MALE, PT WAS IMPLANTED WITH A HEMOBAHN DEVICE TO TREAT A VESSEL DISSECTION, WHICH HAD RESULTED FROM BALLOON DILATION OF A LEFT SFA OCCLUSION. NO ANTIBIOTIC THERAPY WAS ADMINISTERED. THE PT WAS DISCHARGED IN GOOD CONDITION ON A DAILY ASPIRIN REGIMEN. APPROX TWO WEEKS LATER, THE PT PRESENTED WITH A PAINFUL SWOLLEN MASS ON THE INFERIOR ASPECT OF THE THIGH. AN ABSCESS HAD FORMED AROUND THE DEVICE. THE DEVICE WAS PATENT. THE PT RECEIVED IV ANTIBIOTICS, WHICH QUELLED THE SYMPTOMS. THE HEMOBAHN DEVICE WAS PATENT AT LEAST FOUR MONTHS AND TWO WEEKS AFTER IMPLANT WHEN THE PT WAS READMITTED FOR ACUTE LEFT LEG ISCHEMIA. THE PT STATED THAT HE STOPPED TAKING THE PRESCRIBED ORAL ANTIBIOTICS BECAUSE HE FELT WELL. THE LEFT SFA WAS OCCLUDED AND A FEMORO-POPLITEAL BYPASS SURGERY WAS PERFORMED. THE HEMOBAHN DEVICE WAS NOT REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE HEMOBAHN ENDOPROSTHESIS NONE NIO W. L. GORE & ASSOCIATES WLG320

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention