BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 15204124 · Received August 10, 2022

    Report

    Report Number
    2916596-2022-12856
    Event Type
    Injury
    Date Received
    August 10, 2022
    Date of Event
    July 28, 2022
    Report Date
    September 15, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: REVIEW OF THE LOG FILES PROVIDED BY THE ACCOUNT CONFIRMED LOW FLOW ALARMS; HOWEVER, A SPECIFIC CAUSE FOR THESE EVENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. ADDITIONALLY, A DIRECT CORRELATION BETWEEN HEARTMATE (HM) 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER MLP-031295, AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY ESTABLISHED. THE CONTROLLER EVENT LOG FILE CONTAINED DATA FROM 26JUL2022 THROUGH 28JUL2022, PER THE TIMESTAMPS. TRANSIENT LOW FLOW FAULT FLAGS WERE CAPTURED THROUGHOUT THE FILE WHEN THE ESTIMATED FLOW DECREASED BELOW THE LOW FLOW THRESHOLD OF 2.5 LITERS PER MINUTE (LPM), TO A RANGE OF 1.8-2.4 LPM. THESE FAULTS RESULTED IN MULTIPLE LOW FLOW HAZARD ALARMS. DESPITE THE OBSERVED EVENTS, THE PUMP APPEARED TO FUNCTION AS INTENDED AT THE SET SPEED. THE PATIENT REMAINS ONGOING ON HEARTMATE 3 LVAS, SERIAL NUMBER MLP-031295, AND NO FURTHER RELATED EVENTS HAVE BEEN REPORTED AT THIS TIME. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR MLP-031295 WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE IMPLANT KIT WAS SHIPPED ON 24MAR2022. THE HEARTMATE 3 LVAS IFU, REV. C AND THE HEARTMATE 3 PATIENT HANDBOOK, REV. D ARE CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS RIGHT HEART FAILURE AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. SECTION 1 OF THE IFU ALSO ADDRESSES ALL PUMP PARAMETERS, INCLUDING PUMP FLOW. SECTION 4 OF THE IFU, ¿SYSTEM MONITOR¿, DESCRIBES THE PUMP FLOW DISPLAY AND THE HAZARD ALARMS. PER DESIGN, WHEN THE ESTIMATED FLOW VALUE IS CALCULATED AT LESS THAN 2.5 LPM, A LOW FLOW STATUS IS POSTED TO THE LOG FILE. IF THE FLOW REMAINS BELOW 2.5 LPM FOR 10 SECONDS, A LOW FLOW HAZARD ALARM IS TRIGGERED. SECTION 4 ALSO EXPLAINS THAT CHANGES IN PATIENT CONDITION CAN RESULT IN LOW FLOW. SECTION 6 OF THE IFU, ¿PATIENT CARE AND MANAGEMENT¿ (UNDER ¿RIGHT HEART FAILURE¿), STATES THAT PATIENTS MAY DEVELOP RIGHT VENTRICULAR FAILURE DURING OR SHORTLY AFTER IMPLANT AND OUTLINES THE ASSOCIATED TREATMENT OPTIONS. ADDITIONALLY, SECTION 6, UNDER ¿CAUTION!¿, EXPLAINS THAT RIGHT VENTRICULAR DYSFUNCTION, ESPECIALLY WHEN COMBINED WITH ELEVATED PULMONARY VASCULAR RESISTANCE, MAY LIMIT THE EFFECTIVENESS OF THE LEFT VENTRICULAR ASSIST SYSTEM DUE TO REDUCED FILLING OF THE PUMP. SECTION 7 OF THE IFU, ¿ALARMS AND TROUBLESHOOTING¿, AND SECTION 5 OF THE PATIENT HANDBOOK, ¿ALARMS AND TROUBLESHOOTING¿, ADDRESS ALL SYSTEM ALARM CONDITIONS AS WELL AS THE APPROPRIATE ACTIONS ASSOCIATED WITH EACH CONDITION. FURTHERMORE, SECTION 8 OF THE PATIENT HANDBOOK, ¿HANDLING EMERGENCIES¿, ALSO PROVIDES EXAMPLES OF EMERGENCIES AND THE PROPER ACTIONS TO TAKE IN THE EVENT AN EMERGENCY OCCURS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD ACUTE RIGHT VENTRICULAR FAILURE THAT REQUIRED INOTROPES AND A TEMPORARY RIGHT SIDE SUPPORT WITH IMPELLA RP IN THE MORNING OF (B)(6) 2022. THE PATIENT DID NOT HAVE A RIGHT HEART FAILURE BEFORE THE LEFT VENTRICULAR ASSIST DEVICE (LVAD) IMPLANT. IT WAS ALSO REPORTED THAT A DEVICE RELATED ISSUE DID NOT CAUSE OR CONTRIBUTE TO THE RIGHT HEART FAILURE. THE EVENT LOG CONTAINED ROUTINE EVENT WITH A FEW PULSATILITY INDEX (PI) EVENTS FROM (B)(6) 2022 AT 13:51 TO (B)(6) 2922 AT 07:50. THE LOG ALSO CAPTURED INTERMITTENT LOW FLOW ALARMS STARTING FROM (B)(6) 2022 AT 07:55 TO 14:10 AND LOW SPEED ADVISORY WHEN THE SET SPEED WAS CHANGED TO 4400 ROTATIONS PER MINUTE (RPM) AT 09:37. THE CAUSE OF THE ALARMS WERE UNKNOWN AND NO PATIENT SYMPTOMS WERE OBSERVED AS THE PATIENT WAS SEDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1786639 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 8391318 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Hospitalization| R