BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE XVE LVAS

    MDR report key: 1260048 · Received December 10, 2008

    Report

    Report Number
    2916596-2008-00175
    Event Type
    Injury
    Date Received
    December 10, 2008
    Date of Event
    November 10, 2008
    Report Date
    November 14, 2008
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS SUCCESSFULLY EXCHANGED WITH ANOTHER LVAD AND THE PT REMAINS ONGOING. THE MFR IS ATTEMPTING TO ACQUIRE THE EXPLANTED DEVICE FOR FURTHER EVALUATION. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A VENTED ELECTRIC LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE PT THAT BLACK DUST WAS SEEN IN THE VENT FILTER. VENT FILER ANALYSIS SENT TO THE MFR REVEALED EVIDENCE OF CHLORINE POSSIBLY INDICATING SOME FLUID INGRESS. WAVEFORM ANALYSIS ALSO PERFORMED WITH REPORTED VALVE REGURGITATION. SOME AORTIC VALVE INSUFFICIENCY HAD ALSO BEEN NOTED. A DECISION WAS MADE TO REPLACE THE LVAD WITH ANOTHER LVAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE XVE LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 1270

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention