BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 4203097 · Received October 23, 2014

    Report

    Report Number
    2916596-2014-01915
    Event Type
    Injury
    Date Received
    October 23, 2014
    Date of Event
    July 11, 2014
    Report Date
    September 24, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVALUATION OF THE LVAD DID NOT REVEAL A DEVICE RELATED ISSUE AND THE REPORT OF ELEVATED LACTATE DEHYDROGENASE (LDH) COULD NOT BE CONFIRMED. EXAMINATION OF THE BLOOD-CONTACTING SURFACES DID NOT REVEAL ANY ADHERED DEPOSITIONS OR THROMBUS FORMATIONS. VISUAL INSPECTION OF THE PUMP BEARINGS AND BEARING CUPS FOUND NO ANOMALIES. EXAMINATION OF THE RETURNED PORTION OF THE LEAD FOUND IT TO BE UNREMARKABLE. ELECTRICAL CONTINUITY TESTING OF THE LEAD REVEALED NO DISCONTINUITIES OR SHORTS. THE PUMP WAS REASSEMBLED AND OPERATED ON A MOCK CIRCULATORY LOOP AND FUNCTIONED AS INTENDED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED THAT THE DEVICE MET APPLICABLE SPECIFICATIONS. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO THE MANUFACTURER, AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS 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 ON (B)(6) 2014 FOR ELEVATED LDH OF 4000 ("NORMAL" WAS <750), AND WAS PLACED ON A HEPARIN GTT. IT WAS ALSO REPORTED THAT HE LDH TESTING WAS RECENTLY CHANGED OUT AND THE NEW NORMAL WAS <225. ON THE NEW SCALE THE PATIENT'S LDH WAS AS HIGH AS 1100. SHE DID NOT HAVE SIGNS OF HEMOLYSIS. THEY ATTEMPTED SEVERAL TIMES TO TAKE THE PATIENT OFF OF THE HEPARIN GTT, BUT EACH TIME HER LDH ELEVATED AGAIN. THE PATIENT WAS MOVED UP TO 1A ON THE TRANSPLANT LIST, AND RECEIVED A HEART AND KIDNEY TRANSPLANT ON (B)(6) 2014.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION PROVIDED INDICATED THAT THE PATIENT DID NOT HAVE A KNOWN COAGULOPATHY BUT WAS ON CHRONIC HEMODIALYSIS AND URINE WAS ALWAYS DARK. ATTEMPTS TO TAKE PATIENT OFF IV HEPARIN, RESULTED IN ELEVATED LACTATE DEHYDROGENASE (LDH) AFTER 1-2 DAYS. THERE WAS NO VISIBLE CLOT AT THE TIME OF PUMP EXPLANT AND PUMP WAS SENT TO MANUFACTURER LAST WEEK FOR INSPECTION. COULD NOT DETERMINE IF THE ELEVATED LDH WAS DEVICE RELATED. PATIENT UNDERWENT TRANSPLANT AS PREVIOUSLY STATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677054 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 133583

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention