BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 19119794 · Received April 16, 2024

    Report

    Report Number
    2916596-2024-01886
    Event Type
    Death
    Date Received
    April 16, 2024
    Date of Event
    March 11, 2024
    Report Date
    January 28, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION B2: CORRECTED. SECTION B5: CORRECTED. SECTION D1 (BRAND NAME): CORRECTED. SECTION D4 (CATALOG NUMBER): CORRECTED. SECTION D4 (UDI NUMBER): CORRECTED. SECTION H6: CORRECTED. MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LVAS (LEFT VENTRICULAR ASSIST SYSTEM), SERIAL NUMBER MLP-021378, AND THE REPORTED EVENT COULD NOT CONCLUSIVELY BE DETERMINED. THE CONTROLLER EVENT LOG FILE (SEE ATTACHED) CONTAINED EVENTS ON 11MAR2024. NO NOTABLE ALARMS OR UNUSUAL EVENTS WERE RECORDED, AND THE PUMP APPEARED TO HAVE BEEN OPERATING AS INTENDED AT THE SET SPEED. ADDITIONAL INFORMATION REGARDING THE EVENT WAS REQUESTED FROM THE ACCOUNT; HOWEVER, NO FURTHER INFORMATION HAS BEEN COMMUNICATED AT THIS TIME. THE PATIENT REMAINS ONGOING ON HEARTMATE 3 LVAS, SERIAL NUMBER MLP-021378, AND NO FURTHER EVENTS HAVE BEEN REPORTED AT THIS TIME. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR MLP-021378 WERE REVIEWED AND SHOWED NO DEVIATION FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LVAS IFU IS CURRENTLY AVAILABLE. SECTION 1 OUTLINES POTENTIAL ADVERSE EVENTS, INCLUDING RIGHT HEART FAILURE, THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. SECTION 6 STATES: ¿RIGHT HEART FAILURE CAN OCCUR FOLLOWING IMPLANTATION OF THE PUMP. RIGHT VENTRICULAR DYSFUNCTION, ESPECIALLY WHEN COMBINED WITH ELEVATED PULMONARY VASCULAR RESISTANCE, MAY LIMIT THE EFFECTIVENESS OF THE LVAS DUE TO REDUCED FILLING OF THE PUMP.¿ SECTION 7 OUTLINES ALL AUDIBLE/VISUAL ALARMS AND THE ACTIONS TO TAKE IN THE EVENT ONE OCCURS. NO FURTHER INFORMATION PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    SECTION H6 (MEDICAL DEVICE PROBLEM CODE): CORRECTION. MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6), AND THE REPORTED EVENTS AND PATIENT OUTCOME COULD NOT CONCLUSIVELY BE DETERMINED. THE CONTROLLER EVENT LOG FILE CONTAINED EVENTS ON 11MAR2024. NO NOTABLE ALARMS OR UNUSUAL EVENTS WERE RECORDED, AND THE PUMP APPEARED TO HAVE BEEN OPERATING AS INTENDED AT THE SET SPEED. ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS WAS REQUESTED FROM THE ACCOUNT; HOWEVER, NO FURTHER INFORMATION HAS BEEN COMMUNICATED AT THIS TIME. THE PUMP WAS NOT RETURNED FOR EVALUATION. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATION FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LVAS INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. SECTION 1 OUTLINES POTENTIAL ADVERSE EVENTS, INCLUDING RIGHT HEART FAILURE AND DEATH, THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. SECTION 6 STATES: ¿RIGHT HEART FAILURE CAN OCCUR FOLLOWING IMPLANTATION OF THE PUMP. RIGHT VENTRICULAR DYSFUNCTION, ESPECIALLY WHEN COMBINED WITH ELEVATED PULMONARY VASCULAR RESISTANCE, MAY LIMIT THE EFFECTIVENESS OF THE LVAS DUE TO REDUCED FILLING OF THE PUMP.¿. SECTION 7 OUTLINES AUDIBLE/VISUAL ALARMS AND THE ACTIONS TO TAKE IN THE EVENT ONE OCCURS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    THE PATIENT WAS ADMITTED WHEN THEY WERE EXPERIENCING LOW FLOW ALARMS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD LOW FLOW ALARMS WITH DIZZINESS, FATIGUE, NAUSEA, SHORTNESS OF BREATH, AND CHEST PAIN. LOG FILES WERE SUBMITTED FOR REVIEW AND CAPTURED ONLY PULSATILITY INDEX (PI) EVENTS ON 11MAR2024. THE CAUSE OF THE LOW FLOWS WAS IDENTIFIED TO BE WORSENING RIGHT VENTRICULAR FAILURE. THE PATIENT WAS STARTED ON DOBUTAMINE, AND THE LOW FLOW ALARMS RESOLVED. IT WAS NOTED THAT THE PATIENT WAS ALREADY ON MILRINONE.

    Description of Event or Problem · 0

    IT WAS ADDITIONALLY REPORTED THAT THE PATIENT PASSED AWAY ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1856305 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 7421021

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Required Intervention| H| D