BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE APICAL SEWING RING

    MDR report key: 3915427 · Received June 5, 2014

    Report

    Report Number
    2916596-2014-00892
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 6, 2014
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT THAT THE FELT WAS PULLING AWAY FROM THE SILASTIC ON THE APICAL SEWING RING DURING IMPLANT COULD NOT BE CONFIRMED BY THE MANUFACTURER. NO PHOTOGRAPHS WERE TAKEN DURING THE IMPLANT PROCEDURE AND THE PATIENT REMAINS ON-GOING ON LVAD SUPPORT WITH NO FURTHER ISSUES REPORTED. A REVIEW OF DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    NO FURTHER ISSUES HAVE BEEN REPORTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURGEON THAT AT THE TIME OF IMPLANT OF THE LVAD PUMP, THE FELT WAS PULLING AWAY FROM THE SILASTIC ON THE APICAL SEWING RING. THE SURGEON SECURED THE FELT USING BIO GLUE. THE SEWING RING WAS REPLACED AND THE CASE PROCEEDED. IT WAS NOTED THAT THE SURGEON WAS USING THE MANUFACTURER'S INSTRUCTION FOR USE TECHNIQUE DURING THE IMPLANT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: THE PATIENT REMAINS ONGOING ON LVAD SUPPORT AND IS DOING WELL. NO FURTHER ISSUES HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329430 HEARTMATE APICAL SEWING RING DSQ: LVAD APICAL SEWING RING DSQ THORATEC CORPORATION 1065 137751

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention