BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 4739732 · Received April 30, 2015

    Report

    Report Number
    2916596-2015-00779
    Event Type
    Death
    Date Received
    April 30, 2015
    Date of Event
    February 12, 2015
    Report Date
    April 1, 2015
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ATTACHED USER FACILITY MEDWATCH REPORT WAS RECEIVED FROM (B)(4). THE USER FACILITY NUMBER WAS NOT PROVIDED. (B)(4). A REVIEW OF THE MANUFACTURER'S COMPLAINT HISTORY SHOWED THAT THE PATIENT HAD A PUMP EXCHANGE (PLEASE REFERENCE MFR REPORT # 2916596-2015-00132).

    Additional Manufacturer Narrative · 1

    (B)(4). THE ATTACHED USER FACILITY MEDWATCH REPORT WAS RECEIVED FROM THE INTERMACS REGISTRY. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED THAT THE PATIENT WAS READMITTED TWICE WITH PERSISTENT HEMOLYSIS, VOLUME OVERLOAD, AND SUSPECTED PUMP THROMBOSIS. LVAD INTERROGATION ALSO REVEALED ELEVATED FLOWS. THE PATIENT HAD RAMP STUDIES THAT CAME BACK POSITIVE. A DECISION WAS MADE TO UPGRADE THE PATIENT ON THE TRANSPLANT LIST; HOWEVER, THE PATIENT WAS FOUND UNRESPONSIVE ON (B)(6) 2015 AND A CT HEAD SCAN SHOWED A HEMORRHAGIC CEREBROVASCULAR ACCIDENT WITH TERMINAL BLEED. THE PATIENT EXPIRED ON (B)(6) 2015. AN AUTOPSY WAS NOT PERFORMED SO THE PUMP WAS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR ANALYSIS. INFORMATION WAS ALSO RECEIVED FROM THE INTERMACS REGISTRY STATING: READMITTED IN (B)(6) WITH HIGH LDH, HEMOLYSIS AND VOLUME OVERLOAD. VAD INTERROGATION REVEALED HIGH FLOWS. HAD A RAMP STUDY THAT CAME BACK POSITIVE. DECISION WAS MADE TO UPGRADE PATIENT TO UNOS STATUS 1AB.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM (B)(4) STATING: RAMP DONE (NEGATIVE), BUT GIVEN HEMOLYSIS (ELEVATED LDH 2314, PFHGB 34 & TRENDING UP) THERE IS HIGH SUSPICION FOR THROMBUS. DECISION MADE TO EXCHANGE VAD ((B)(6) 2014). THROMBUS VISUALIZED IN INLET STATOR ON EXPLANTED DEVICE. PUMP RETURNED TO THORATEC FOR ANALYSIS. ADDITIONAL INFORMATION ALSO STATED THAT THE PATIENT EXPIRED ON (B)(6) 2015 AND INDICATED THE PRIMARY CAUSE OF DEATH AS NERVOUS SYSTEM - NEUROLOGICAL DYSFUNCTION, DEVICE FUNCTION NORMAL: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284828 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death| H| R