BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 18466048 · Received January 8, 2024

    Report

    Report Number
    2916596-2023-08859
    Event Type
    Death
    Date Received
    January 8, 2024
    Date of Event
    December 18, 2023
    Report Date
    July 10, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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

    D1: BRAND NAME: CORRECTED D3: MANUFACTURER INFORMATION: CORRECTED D4: CATALOG NUMBER AND UDI: CORRECTED. G1: CONTACT OFFICE (AND MANUFACTURING SITE FOR DEVICES): CORRECTED MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE (HM) 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6) AND THE REPORTED BLEEDING AND PATIENT OUTCOME COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. A REVIEW OF THE SUBMITTED LOG FILES REVEALED LOW FLOW ALARMS AND CONTINUOUS LEFT VENTRICULAR ASSIST DEVICE (LVAD) FAULT ALARMS. PUMP TEMPERATURE WAS ELEVATED WELL ABOVE BASELINE AND THE PUMP ROTOR WAS DISPLACED OUTSIDE NORMAL RANGE. IT WAS REPORTED THAT HEARTMATE 3 LVAS, SERIAL NUMBER (B)(6) WAS NOT RETURNED FOR EVALUATION. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. SECTION 1 OF THIS DOCUMENT LISTS ADVERSE EVENTS, INCLUDING BLEEDING, THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. SECTION 6, ¿PATIENT CARE AND MANAGEMENT¿ (UNDER ¿ANTICOAGULATION¿), ALSO PROVIDES THE RECOMMENDED ANTICOAGULATION REGIMEN, INCLUDING INTERNATIONAL NORMALIZED RATIO (INR) RANGE, AS WELL AS SUGGESTED ANTICOAGULATION MODIFICATIONS. SECTION 7 ¿ALARMS AND TROUBLESHOOTING¿ DESCRIBES SYSTEM ALARM CONDITIONS, INCLUDING THE LEFT VENTRICULAR ASSIST DEVICE (LVAD) FAULT ALARM, AS WELL AS THE APPROPRIATE ACTIONS ASSOCIATED WITH THEM. THE HEARTMATE 3 LVAS PATIENT HANDBOOK IS CURRENTLY AVAILABLE. SECTION 5 "ALARMS AND TROUBLESHOOTING" OUTLINES SYSTEM CONTROLLER ALARMS AS WELL AS HOW TO RESPOND TO EACH ALARM CONDITION. FURTHERMORE, THE PATIENT HANDBOOK INSTRUCTS THE USER TO CALL THEIR HOSPITAL CONTACTS IF THEY THINK, FOR ANY REASON, ANY PORTION OF THEIR EQUIPMENT IS NOT FUNCTIONING AS USUAL, IS BROKEN, OR THEY ARE UNCOMFORTABLE WITH THE OPERATION OF THE EQUIPMENT. 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 WAS FOUND UNRESPONSIVE, COLD, AND APNEIC THE MORNING OF (B)(6) 2023. DOWNTIME WAS UNKNOWN AND COPIOUS ORAL BLEEDING WAS NOTED. THE PATIENT'S TIME OF DEATH WAS NOTED SHORTLY AFTER THE PATIENT ARRIVED IN THE ER. SYSTEM CONTROLLER INTERROGATION REVEALED MULTIPLE LOW FLOW AND LEFT VENTRICULAR ASSIST DEVICE (LVAD) FAULT ALARMS. LOG FILES WERE SUBMITTED FOR REVIEW AND CAPTURED NUMEROUS LOW FLOW AND INTERNAL FAULT ALARMS ON (B)(6) 2023.THE PUMP TEMPERATURE WAS ELEVATED WELL ABOVE BASELINE AND THE PUMP ROTOR WAS DISPLACED OUTSIDE NORMAL RANGE.

    Description of Event or Problem · 0

    IT WAS ADDITIONALLY REPORTED THAT THE CAUSE OF DEATH WAS BELIEVED TO BE MASSIVE BLOOD LOSS DUE TO UPPER GASTROINTESTINAL BLEED. THE CAUSE OF THE LOW FLOW ALARMS WAS BELIEVED TO BE DUE TO HYPOVOLEMIA RELATED TO MASSIVE BLOOD LOSS AND THE ELEVATED PUMP TEMPERATURE WAS BELIEVED TO BE CAUSED BY COAGULATION OF BLOOD IN THE SETTING OF CARDIAC STANDSTILL FOR A PROLONGED PERIOD OF TIME. LEFT VENTRICULAR ASSIST DEVICE (LVAD) OPERATED AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    986836 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 6770972 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Death