BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROPATEN

    MDR report key: 1673544 · Received April 22, 2010

    Report

    Report Number
    1673544
    Event Type
    Injury
    Date Received
    April 22, 2010
    Date of Event
    April 21, 2010
    Report Date
    April 22, 2010
    Manufacturer
    GORE
    Product Code
    DSY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    GRAFT IS DESIGNED TO PREVENT CLOTS; PATIENT HAD THIS ARTERIAL VENOUS (AV) FISTULA GRAFT INSERTED BY SURGEON. HEPARIN SOLUTION WAS UTILIZED. VENDOR REPRESENTATIVE PRESENT DURING PROCEDURE (SURGEON'S INITIAL EXPERIENCE WITH GRAFT). WITHIN HOURS IT CLOTTED AND PATIENT HAD TO RETURN EMERGENTLY TO THE OR AND UNDERGO GENERAL ANESTHESIA AND HAVE ANOTHER PROCEDURE PERFORMED TO REMOVE GORE GRAFT. PATIENT WAS FINE AFTER THE SECOND PROCEDURE.====================== HEALTH PROFESSIONAL'S IMPRESSION======================GRAFT CLAIMS IT IS DESIGNED NOT TO CLOT. THIS GRAFT CLOTTED ALMOST IMMEDIATELY AFTER SURGERY REQUIRING EMERGENCY RETURN TO SURGERY. REVISION OF AV GRAFT, THROMBECTOMY, CREATION OF RADIAL CEPHALIC FISTULA AND REMOVAL OF GRAFT, LEFT ARM.====================== MANUFACTURER RESPONSE FOR AV FISTULA VASCULAR GRAFT, GORE======================VENDOR FIRST RESPONSE WAS TO PICK UP GRAFT. I INFORMED HIM A REPORT WAS BEING FILED. HE IS CALLING THE COMPANY TO DISCUSS HOW THE VENDOR DESIRES THE GRAFT TO BE RETURNED AND TO WHICH DEPARTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROPATEN PROSTHESIS, VASCULAR GRAFT, OF 6 MM AND GREATER DIAMETER DSY GORE * 3139866PPO26

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| R