BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3667572 · Received February 11, 2014

    Report

    Report Number
    2916596-2014-00111
    Event Type
    Death
    Date Received
    February 11, 2014
    Date of Event
    January 9, 2014
    Report Date
    January 13, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE REFERENCE MFR REPORT # 2916596-2013-01774 FOR INFORMATION REGARDING THE FIRST LVAD. A CORRELATION BETWEEN THE LVAD (DEVICE) AND THE REPORT OF SUSPECTED THROMBUS COULD NOT BE DETERMINED. NO AUTOPSY WAS PERFORMED AND THE DEVICE WAS NOT RETURNED. ALTHOUGH THE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT CONCLUSIVELY BE DETERMINED WITHOUT AN EVALUATION OF THE LVAD, THE DEVICE'S APPROVED LABELING LISTS DEVICE THROMBOSIS AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE LEFT VENTRICULAR ASSIST SYSTEM (LVAS). A REVIEW OF DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. 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 INFORMATION FROM THE HOSPITAL REGARDING THE STATUS OF THE DEVICE AND WHETHER IT WILL BE RETURNING FOR EVALUATION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    PER USER FACILITY REPORT RECEIVED FROM THE (B)(6) REGISTRY: DATE OF EVENT: (B)(6) 2014: PUMP THROMBOSIS. OUTCOME DEATH (B)(6) 202014. THE FOLLOW-UP INFORMATION RECEIVED FROM THE VAD COORDINATOR STATED THAT THE PATIENT¿S SIGNS OF PUMP THROMBOSIS WERE ELEVATED LACTATE DEHYDROGENASE, LOW HAPTOGLOBIN, POWER FLUCTUATIONS. AT THE TIME OF THIS EVENT, THE PATIENT WAS ON THE SECOND LVAD AND REPORTEDLY DID NOT LEAVE THE HOSPITAL FOLLOWING THE PUMP EXCHANGE PROCEDURE. THE PRE-OPERATION WORKUP HAD NOT INDICATED ANY PRE-EXISTING CONDITION. AN AUTOPSY WAS NOT PERFORMED FOLLOWING THE PATIENT DEATH AND THE PUMP WOULD NOT BE RETURNED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE MFR RECEIVED A REPORT THROUGH DEVICE TRACKING INDICATING THAT THE PT EXPIRED DUE TO PUMP THROMBOSIS. NO OTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91308 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 106015 133950

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Death