BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 8865520 · Received August 6, 2019

    Report

    Report Number
    2916596-2019-03687
    Event Type
    Injury
    Date Received
    August 6, 2019
    Date of Event
    July 20, 2019
    Report Date
    October 11, 2019
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE REPORTED EVENTS (BLEEDING, PNEUMONIA, PI EVENTS, POWER CABLE DISCONNECT) AND HEARTMATE 3 LVAS COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. THE PATIENT REMAINS ONGOING ON HEARTMATE 3 LVAS. THE HM3 LVAS IFU LISTS BLEEDING AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM AND PROVIDES INFORMATION REGARDING ANTICOAGULATION, INCLUDING THE RECOMMENDED INR RANGE. THE IFU ALSO EXPLAINS THAT PI EVENTS ARE ASSUMED BY THE SYSTEM DURING CASES WHEN THERE ARE SUDDEN AND SUBSTANTIAL CHANGES IN THE PULSATILITY INDEX. THESE EVENTS ARE ALSO REFERRED TO AS PI EVENTS, AND MAY BE INITIATED FOR REASONS OTHER THAN TRUE PI EVENTS. SOME REASONS INCLUDE SUDDEN CHANGES IN A PATIENT¿S VOLUME STATUS, ARRHYTHMIAS, SUDDEN CHANGES IN POWER, AND SUDDEN CHANGES IN PUMP SPEED. THE IFU ALSO DESCRIBES ALL ALARM CONDITIONS, INCLUDING POWER CABLE DISCONNECT ALARMS, AS WELL AS THE APPROPRIATE ACTIONS ASSOCIATED WITH THEM. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE PATIENT PRESENTED WITH ANEMIA AND PNA. THE PATIENT HAD LABS DONE SHOWING ANEMIA AND WAS STARTED ON INTRAVENOUS VANCOMYCIN AND IMIPENEM FOR PNA. THE PATIENT HAD BEEN REFUSING TO COME TO THE HOSPITAL AND HAS REFUSED TO GO TO ANY OUTPATIENT APPOINTMENTS WITH CHF. THE PATIENT WAS SEEN AT BEDSIDE IN THE EMERGENCY ROOM, THE PATIENT WAS MONITORED AND LVAD WAS INTERROGATED. INTERROGATION SHOWED MULTIPLE PI EVENTS BUT NO SIGNIFICANT SPEED DROPS. FLOW WAS 3.5, SPEED WAS 5000, PI WAS 4.6, AND POWER WAS 3.3. THE PATIENT WAS EATING A SANDWICH WHILE ON THE VENT AND FOR A SECOND. NO FEVER OR LEUKOCYTOSIS NOTED, AND NO MELENA PER THE PATIENT. THE PATIENT FURTHER DENIES CURRENT CHEST PAIN, SHORTNESS OF BREATH, NAUSEA, VOMITING, FEVER, AND CHILLS. THE NIGHT NURSE CALLED CT SURGERY FOR DISCONNECTING BLACK POWER CABLE FROM BEDSIDE LVAD BATTERY SOURCE TO CONNECT TO THE PATIENT'S BATTERY. THE PATIENT IS ALERT, ORIENTED AND WRITING TO COMMUNICATE. THE PATIENT HAS TRACH TUBE TO VENT AND SELF SUCTION ORALLY AND IS BEING TRANSFERRED AFTER RECEIVING 2 UNITS OF PACKED RED BLOOD CELLS.

    Additional Manufacturer Narrative · 1

    THE HEARTMATE 3 LVAS WAS IMPLANTED DURING THE (B)(6) CLINICAL TRIAL, IDE # (B)(4). FDA APPROVAL FOR HEARTMATE 3 LVAS WAS RECEIVED ON 23 AUGUST 2017. THE GTIN UNIQUE DEVICE IDENTIFIER FOR THE COMMERCIAL HEARTMATE3 LVAS IS (B)(4). NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2018. IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM ON (B)(6) 2019 FOR LOW HEMOGLOBIN & HEMATOCRIT. THE PATIENT WAS TRANSFUSED TWO UNITS OF PACKED RED BLOOD CELLS AND DISCHARGED BACK TO THEIR SUBACUTE REHABILITATION FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660585 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM LEFT VENTRICULAR ASSIST SYSTEM DSQ THORATEC CORPORATION 106524 6305157

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other| R