BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM

    MDR report key: 2113679 · Received June 1, 2011

    Report

    Report Number
    2916596-2011-00203
    Event Type
    Injury
    Date Received
    June 1, 2011
    Date of Event
    May 5, 2011
    Report Date
    May 10, 2011
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT REMAINS ONGOING WITH THE REPLACEMENT PUMP WITH NO FURTHER ISSUES REPORTED. THE MANUFACTURER IS ATTEMPTING TO ACQUIRE THE EXPLANTED PUMP FOR ANALYSIS. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. APPROXIMATELY 1 WEEK POST-IMPLANT, A FIBRIN DEPOSIT WAS OBSERVED WITHIN THE PUMP NEAR THE OUTFLOW CANNULA. ANTICOAGULATION WAS MANAGED WITH HEPARIN FOLLOWED BY ASPIRIN. A DECISION WAS MADE TO EXCHANGE THE PUMP. THERE WAS NO INJURY SUSTAINED BY THE PATIENT DURING THS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 14086-2550-000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention