BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 1669139 · Received April 26, 2010

    Report

    Report Number
    2916596-2010-00102
    Event Type
    Death
    Date Received
    April 26, 2010
    Date of Event
    March 18, 2010
    Report Date
    March 22, 2010
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF PT EXPIRATION AND POTENTIAL THROMBUS CANNOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR EVAL AS NO AUTOPSY WAS PERFORMED AND THE DEVICE REMAINED WITH THE PT. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FOR MFG OR QA SPECS. BASED ON THE INFO AVAILABLE, NO CONCLUSION CAN BE DRAWN AS TO THE CAUSE OF THIS EVENT. NO FURTHER INFO IS AVAILABLE. THE MFR IS CLOSING ITS FILE ON THIS EVENT. AS A PARTICIPANT IN THE (B) (4) REGISTRY, THORATEC WAS GRANTED AS OF (B) (6) 2007, AN EXEMPTION FROM THE 30 DAY CALENDAR REPORTING REQUIREMENT IN 21 CFR 803.50 FOR EVENTS RELATED TO MEDICAL DEVICES ELIGIBLE FOR INCLUSION IN THE (B) (4) REGISTRY. PER THIS EXEMPTION, THESE EVENTS ARE DUE TO THE FDA NO LATER THAN 90 CALENDAR DAYS FROM AWARENESS DATE. THE SITE WHO SUBMITTED THIS EVENT IS AN ACTIVE (B) (4) MEMBER AND THE ASSOCIATED MEDICAL DEVICE IS INCLUDED IN THE (B) (4) REGISTRY.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE VAD COORDINATOR REPORTED THAT THE PT HAD EXPIRED. PER THE VAD COORDINATOR, THE PT WAS PRESENTED IN CARDIOGENIC SHOCK, AND IT WAS BELIEVED THE DEVICE WAS EITHER THROMBOSED OR OBSTRUCTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 1355 71144

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death