BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3210359 · Received July 2, 2013

    Report

    Report Number
    2916596-2013-00845
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    May 24, 2013
    Report Date
    June 7, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION AVAILABLE AND DUE TO THE DEVICE NOT BEING RETURNED FOR ANALYSIS, A DIRECT CORRELATION BETWEEN THE PUMP AND THE REPORTED EVENT COULD NOT CONCLUSIVELY BE DETERMINED. ALTHOUGH NO CONCLUSION COULD BE DRAWN AS TO THE CAUSE OF THE REPORTED EVENT, THROMBOSIS IS LISTED IN THE DEVICE¿S APPROVED LABELING AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE LEFT VENTRICULAR ASSIST SYSTEM (LVAS). A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED THE PUMP MET ALL APPLICABLE SPECIFICATIONS UPON PRODUCT RELEASE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE MFR IS ATTEMPTING TO ACQUIRE ADDITIONAL INFO FROM THE HOSPITAL REGARDING THE EVENT. THE ATTACHED USER FACILITY REPORT #(B)(4). 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 LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE MFR RECEIVED USER FACILITY REPORT # (B)(4) WHICH STATED THAT AN ECHOCARDIOGRAM (ECHO) INDICATED A MOBILE THROMBUS VISUALIZED IN THE LVAD CANNULA. NO FURTHER INFO WAS PROVIDED.

    Description of Event or Problem · 1

    THE PATIENT CONTINUED ON LVAD SUPPORT FOR ANOTHER 13½ MONTHS AND EXPIRED ON (B)(6) 2014 WHILE IN HOSPICE CARE. A DECISION WAS REPORTEDLY MADE BY THE HOSPITAL NOT TO TREAT FOR THROMBUS BECAUSE THE PATIENT WAS "CLOTTING NONSTOP". AN AUTOPSY WAS NOT PERFORMED WHEN THE PATIENT EXPIRED AND THE PUMP WAS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302085 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 121672

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention