BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 4132841 · Received September 29, 2014

    Report

    Report Number
    2916596-2014-01695
    Event Type
    Injury
    Date Received
    September 29, 2014
    Date of Event
    August 28, 2014
    Report Date
    September 1, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE PATIENT REMAINS ONGOING ON LVAD SUPPORT. INFORMATION REGARDING THE CURRENT PATIENT STATUS WAS REQUESTED, BUT NOT PROVIDED. A CORRELATION BETWEEN THE DEVICE AND THE SUSPECTED PUMP THROMBUS COULD NOT BE CONCLUSIVELY DETERMINED. BASED ON THE MANUFACTURER¿S PAST EXPERIENCE AND SIMILAR REPORTED EVENTS, ELEVATED LDH AND INCREASES IN POWER CAN BE INDICATIVE OF DEVICE THROMBOSIS. A LOG FILE WAS SUBMITTED AND CAPTURED DATA FROM (B)(6) 2014 THAT PRIMARILY CONSISTED OF PI EVENTS. NO NOTABLE HAZARD ALARM CONDITIONS WERE RECORDED THROUGHOUT THE LOG FILE. THE POWER RANGED BETWEEN 4.7-8.9 WATTS, WITH TRANSIENT ELEVATIONS UP TO 11.9 WATTS; THE ESTIMATED FLOW VARIED FROM 4.1-11.4 LPM; AND THE AVERAGE PI WAS BETWEEN 1.2 AND 5.8. THE INSTRUCTIONS FOR USE LISTS DEVICE THROMBOSIS, HEMOLYSIS, AND RIGHT HEART FAILURE AS POSSIBLE ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED THAT THE DEVICE MET APPLICABLE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE PATIENT REMAINS ON GOING WITH THE IMPLANTED DEVICE AND NO FURTHER ISSUES HAVE BEEN REPORTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. 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 BY THE VAD COORDINATOR THAT THE PATIENT WAS ADMITTED WITH WIDELY VARYING FLOW ESTIMATES AND POWERS. PUMP THROMBUS IS SUSPECTED. THE LACTATE DEHYDROGENASE (LDH) LEVEL INCREASED FROM 900 TO 1400. ON ECHO, THE PATIENT HAS RIGHT VENTRICLE INSUFFICIENCY AND LEFT VENTRICLE STILL UNLOADING. DATA LOG FILES WERE SUBMITTED TO THE MANUFACTURER FOR REVIEW WHICH CONFIRMED PULSATILITY INDEX (PI) EVENTS AND POWER FLUCTUATIONS. PL AVERAGE IS TRENDING DOWNWARD AND THE SPEED DROPS APPEAR TO BE DUE TO MULTIPLE PL EVENTS WHICH MAY BE DUE TO THE SUSPECTED THROMBUS. PATIENT STARTED ON HEPARIN DRIP AS A BRIDGE, CURRENTLY ON INTEGRILIN AND ARGATROBAN. CT SCAN AND CHEST X-RAY ALL REPORTED TO BE OK. THE CURRENT LDH LEVEL IS 2987 AND SHOWING SIGNS OF RIGHT VENTRICULAR FAILURE. THE SURGEON DOES NOT WANT TO EXCHANGE THE PATIENT AGAIN AND WANTS TO ADMINISTER LOW DOSE TPA. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606469 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 106015 136668

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention