BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)

    MDR report key: 9952160 · Received April 13, 2020

    Report

    Report Number
    2916596-2020-01679
    Event Type
    Malfunction
    Date Received
    April 13, 2020
    Date of Event
    March 7, 2020
    Report Date
    June 15, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011224
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: REVIEW OF THE SUBMITTED SYSTEM CONTROLLER LOG FILE DATA CONFIRMED THE REPORTED ELEVATIONS IN PUMP POWER/ESTIMATED FLOW. ONE SEQUENCE OF HIGH POWER WAS ASSOCIATED WITH A LOW SPEED OPERATION EVENT. ACCORDING TO THE ACCOUNT, THE CAUSE OF THE ELEVATED PUMP POWER WAS NOT CONFIRMED BUT WAS ASSUMED TO HAVE BEEN A THROMBUS PASSING THROUGH THE PUMP. THE REPORT OF PUMP THROMBOSIS COULD NOT BE CONFIRMED THROUGH THIS EVALUATION. MOREOVER, A SPECIFIC CAUSE FOR THE REPORTED ELEVATED LDH AND A DIRECT CORRELATION WITH THE DEVICE COULD NOT BE DETERMINED THROUGH THIS EVALUATION. THE SUBMITTED SYSTEM CONTROLLER LOG FILES CUMULATIVELY CONTAINED DATA FROM (B)(6) 2020 ¿ (B)(6) 2020 AND SHOWED THAT PUMP POWER INITIALLY REMAINED OVERALL STABLE IN THE RANGE OF ABOUT 5.0-6.5 WATTS UNTIL THE EVENING OF (B)(6) 2020 WHEN POWER INCREASED TO THE RANGE OF ABOUT 8.0-9.0 WATTS. PUMP POWER CONTINUED TO FLUCTUATE BETWEEN THESE HIGHER AND LOWER RANGES THROUGH THE REMAINING LOG FILE DATA, SOMETIMES INCREASING ABOVE 10 WATTS. THE MAJORITY OF POWER ELEVATIONS WERE ASSOCIATED WITH PI EVENTS. ON (B)(6) 2020 AT 9:47 PM, A REDUCTION IN PUMP SPEED TO 8010 RPM (990 RPM BELOW THE LOW SPEED LIMIT) WAS CAPTURED WHILE THE SYSTEM WAS OPERATING ON THE POWER MODULE, RESULTING IN AN ACTIVE LOW SPEED OPERATION FLAG. A SPECIFIC CAUSE FOR THE LOW SPEED OPERATION EVENT COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION; HOWEVER, PUMP POWER ELEVATIONS OVER 11 WATTS OCCURRED SHORTLY BEFORE THE EVENT, PUMP POWER THEN INCREASED TO 12.5 WATTS DURING THE EVENT, AND A REDUCTION IN POWER BELOW 10 WATTS WAS NOTED FOLLOWING THE EVENT, SUGGESTING THAT SOMETHING, POSSIBLY A THROMBUS, MAY HAVE POTENTIALLY PASSED THROUGH THE PUMP. PI EVENTS OCCURRED BOTH PRIOR TO AND FOLLOWING THE EVENT WHILE THE HIGHER POWERS THAT OCCURRED AT THAT TIME ALSO CORRELATED WITH SLIGHTLY LOWER AVERAGE PI VALUES. NO ADDITIONAL LOW SPEED EVENTS OR ATYPICAL ALARMS WERE CAPTURED THROUGHOUT THE LOG FILE DATA. ALL OF THE ELEVATIONS IN PUMP POWER CAPTURED IN THE LOG FILE DATA CORRELATED WITH ELEVATIONS IN ESTIMATED FLOW PEAKING AT 12 LPM. NO FURTHER ELEVATIONS IN PUMP POWER/ESTIMATED FLOW WERE OBSERVED AFTER THE EVENING OF (B)(6) 2020. THE ACCOUNT COMMUNICATED ON (B)(6) 2020 THAT THE PATIENT¿S LDH THAT DAY WAS 619, WHICH WAS REDUCED FROM 809 ON (B)(6) 2020. A CT SCAN WAS REPORTEDLY NEGATIVE FOR OUTFLOW GRAFT STENOSIS. THE PATIENT¿S INR GOAL WAS INCREASED TO 2.5-3.0 DUE TO HIGH CONCERNS FOR PUMP THROMBOSIS. ADDITIONAL INFORMATION PROVIDED BY THE ACCOUNT ON (B)(6) 2020 INDICATED THAT THE CAUSE OF THE ELEVATED PUMP POWER WAS NOT CONFIRMED BUT WAS ASSUMED TO HAVE BEEN A THROMBUS PASSING THROUGH THE PUMP. THE PATIENT REPORTEDLY EXHIBITED NO VISIBLE CLINICAL SYMPTOMS. THE CENTER¿S TREATMENT AND PLAN OF CARE WAS TO CONTINUE THE PATIENT ON A HIGHER THERAPEUTIC INR GOAL. THE PATIENT REMAINS ONGOING ON (B)(6) AND NO ADDITIONAL RELATED EVENTS HAVE BEEN REPORTED AT THIS TIME. THE HEARTMATE II LVAS IFU LISTS DEVICE THROMBOSIS, PERIPHERAL THROMBOEMBOLIC EVENT, AND HEMOLYSIS AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD HIGH FLOWS AND HIGH POWER CONSUMPTION OVERNIGHT ON (B)(6) 2020. LOG FILE ANALYSIS SHOWED A PUMP SPEED DROP ON (B)(6) 2020. THIS COUPLED WITH POWER ELEVATIONS ALONG WITH A NUMBER OF PI EVENTS OCCURRING AT THIS TIME CAN BE SUSPECT OF SOMETHING PASSING THROUGH OR INGESTED INTO THE PUMP. THERE WERE A NUMBER OF OTHER POWER ELEVATIONS CAPTURED IN THE FILE. IT WAS LATER REPORTED THAT THE PATIENT HAD A LACTATE DEHYDROGENASE (LDH) TREND OF 809 ON (B)(6) 2020, 687 ON (B)(6) 2020, 718 ON (B)(6) 2020, 641 ON (B)(6) 2020, AND 619 ON (B)(6) 2020. A COMPUTED TOMOGRAPHY (CT) SCAN WAS NEGATIVE FOR OUTFLOW GRAFT STENOSIS AND THE PATIENT HAD A REPEAT RAMP STUDY WITH ECHOCARDIOGRAPHY. THE PATIENT INTERNATIONAL NORMALISED RATIO INCREASED TO 2.5-3.0 AND CAUSED HIGH CONCERNS OF PUMP THROMBOSIS. IT WAS LATER REPORTED THAT THROMBUS WAS NOT CONFIRMED, BUT ASSUMED TO BE PASSING THROUGH. THE PATIENT HAD NO VISIBLE SYMPTOMS BEYOND THE INFORMATION ON THE PUMP AND THE TREATMENT INCLUDED A HIGHER INTERNATIONAL NORMALISED RATIO (INR) GOAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416437 HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS) VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106015 6559979 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other