BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 20271355 · Received September 20, 2024

    Report

    Report Number
    2916596-2024-06098
    Event Type
    Death
    Date Received
    September 20, 2024
    Date of Event
    August 24, 2024
    Report Date
    December 26, 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
    NM, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    B3: UPDATED EVENT DATE. B5: ADDITIONAL INFORMATION. H6: UPDATED HEALTH EFFECT- CLINICAL, HEALTH EFFECT- IMPACT, AND MEDICAL DEVICE PROBLEM CODES ADDITIONAL HEALTH EFFECT-CLINICAL CODES: E1020-NAUSEA, E060110-VENTRICULAR FIBRILLATION, E050304-THROMBOEMBOLISM. NO FURTHER INFORMATION PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    SECTION B1: TYPE OF REPORT CORRECTED. MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6), AND THE PATIENT¿S OUTCOME COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. AN AUTOPSY WAS NOT PERFORMED, AND THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. ADDITIONAL INFORMATION REGARDING THE EVENT WAS REQUESTED FROM THE ACCOUNT; HOWEVER, NONE HAS BEEN PROVIDED AT THIS TIME. 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 LEFT VENTRICULAR ASSIST SYSTEM INSTRUCTIONS FOR USE (REV. B) CONTAINS THE FOLLOWING INFORMATION: SECTION 1 OUTLINES POTENTIAL ADVERSE EVENTS, INCLUDING THROMBOEMBOLISM, CARDIAC ARRHYTHMIA, AND DEATH, THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. SECTION 6 LISTS THROMBOEMBOLISM AND CARDIAC ARRHYTHMIA AS POTENTIAL LATE POST-IMPLANT COMPLICATIONS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. INFORMATION REGARDING RECOMMENDED ANTICOAGULATION THERAPY AND INTERNATIONAL NORMALIZED RATIO RANGE IS ALSO PROVIDED IN THIS SECTION. SECTION 7 OUTLINES VISUAL/AUDIBLE ALARMS, AS WELL AS THE RECOMMENDED ACTIONS TO RESOLVE THEM. 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 PASSED AWAY AND THAT THE CAUSE WAS UNKNOWN. THE VENTRICULAR ASSIST DEVICE COORDINATOR REPORTED THAT THE PATIENT EXPIRED DUE TO NON-PUMP RELATED COMPLICATIONS. IT WAS STATED THAT OUTCOME WAS NOT DEVICE OR THERAPY RELATED. AN AUTOPSY WAS NOT PERFORMED. THE PUMP WAS NOT EXPLANTED AND WOULD NOT BE RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WHO HAD BEEN IMPLANTED (B)(6) 2024 AND DISCHARGED (B)(6) 2024, WAS READMITTED ON (B)(6) 2024 FOR SHORTNESS OF BREATH AND NEAR SYNCOPE. THEY WERE FOUND TO HAVE VENTRICULAR FIBRILLATION (VF)/ VENTRICULAR TACHYCARDIA (VT), CHEST PAIN, NAUSEA, AND HYPOTENSION. THEY REPORTED SUDDEN WORSENING CHEST PAIN ON (B)(6) 2024 WITH TROPONIN INCREASE TO 7/7. A TRANSTHORACIC ECHOCARDIOGRAM (TEE) DEMONSTRATED AORTIC ROOT THROMBUS, DOWN THE LEFT CORONARY ARTERY. A PROTEK DUO RVAD WAS PLACED IN THE CATHETER LAB PRIOR TO INTERVENTION. OCCLUSIONS OF LEFT MAIN, LEFT ANTERIOR DESCENDING (LAD), AND LEFT CIRCUMFLEX ARTERY (LCX) WERE FOUND. A THROMBECTOMY WAS ATTEMPTED, DURING WHICH THE THROMBUS PROLAPSED ACROSS THE AORTIC VALVE AND SUDDENLY THE DURABLE LEFT VENTRICULAR ASSIST DEVICE (LVAD) STOPPED WITH LOW FLOW ALARMS PRESUMABLE DUE TO ACUTE EMBOLISM FROM THE AORTIC ROOT THROMBUS. IT WAS THOUGHT THAT THE THROMBUS MAY HAVE POSSIBLY BEEN PUSHED INTO THE PUMP DURING THE ATTEMPT. THE THROMBECTOMY WAS UNSUCCESSFUL. THE PATIENT WAS THEN CONVERTED TO VENOARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION (VA ECMO), ALTEPLASE BOLUS WAS GIVEN TO THE INFLOW CANNULA WITHOUT IMPROVEMENT. PUMP FLOW REMAINED 0. PATIENT WAS TRANSFERRED TO INTENSIVE CARE UNIT (ICU) ON SIGNIFICANT VASOPRESSOR SUPPORT AND FAMILY MADE THE DECISION TO WITHDRAW MECHANICAL AND VENTILATORY SUPPORT. THE PATIENT PASSED AWAY (B)(6) 2024. THE FAMILY DECLINED AN AUTOPSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1354302 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US L00000580 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Death