BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 20858406 · Received December 5, 2024

    Report

    Report Number
    2916596-2024-07842
    Event Type
    Death
    Date Received
    December 5, 2024
    Date of Event
    November 14, 2024
    Report Date
    February 25, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: HEALTH EFFECT-IMPACT CODE, UPDATED. NO FURTHER INFORMATION PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    H6: ADDITIONAL HEALTH EFFECT-CLINICAL CODES: ANEMIA-E0301. MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6), AND THE REPORTED EVENTS AND SUBSEQUENT PATIENT OUTCOME COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS 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 LVAS IFU AND THE HEARTMATE 3 PATIENT HANDBOOK ARE CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS POTENTIAL ADVERSE EVENTS, INCLUDING MULTIPLE TYPES OF ORGAN FAILURE AND DYSFUNCTION (RESPIRATORY FAILURE AND RENAL DYSFUNCTION), STROKE, INFECTION, BLEEDING, AND DEATH, THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. SECTION 6, ¿PATIENT CARE AND MANAGEMENT¿ (UNDER ¿ANTICOAGULATION¿), PROVIDES THE RECOMMENDED ANTICOAGULATION REGIMEN, INCLUDING INTERNATIONAL NORMALIZED RATIO (INR) RANGE, AS WELL AS SUGGESTED ANTICOAGULATION MODIFICATIONS. THIS SECTION ALSO LISTS INFECTION AS A POTENTIAL LATE POSTIMPLANT COMPLICATION. SEVERAL SECTIONS OF THE IFU AND PATIENT HANDBOOK PROVIDE CARE INSTRUCTIONS REGARDING HOW TO PREVENT INFECTION AS WELL AS SUGGESTED RESPONSES IN THE EVENT OF INFECTION. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    THE PATIENT THEN PASSED AWAY ON (B)(6) 2024 AFTER THE FAMILY DECIDED TO WITHDRAW SUPPORT. WHETHER THE OUTCOME WAS DEVICE OR THERAPY RELATED WAS NOT PROVIDED BY THE CUSTOMER. AN AUTOPSY WAS NOT PERFORMED AND NOT PROVIDED. THE PUMP WAS NOT EXPLANTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A LARGE RIGHT MIDDLE CEREBRAL ARTERY (MCA) INFARCT. PATIENT STATUS WAS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A POST OPERATIVE CEREBRAL VASCULAR ACCIDENT WITH LARGE RIGHT MIDDLE CEREBRAL ARTERY (MCA) INFARCT. NEUROLOGY WAS CONSULTED. A HEAD COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED SHOWING THE LARGE RIGHT MCA DISTRIBUTION INFARCT. NO EVIDENCE OF HEMORRHAGE OR HEMORRHAGIC CONVERSION WAS SEEN. THERE WAS A MASS EFFECT UPON THE RIGHT LATERAL VENTRICULAR SYSTEM. HOWEVER, THERE WAS NO SIGNIFICANT MIDLINE SHIFT. THE PATIENT WAS NOTED FOR MEDIASTINAL BLEEDING AND WAS TAKEN BACK TO THE OPERATING ROOM ON (B)(6)2025 FOR WASHOUTS. THE POST OPERATIVE COURSE WAS COMPLICATED BY ANEMIA REQUIRING INTERMITTENT TRANSFUSIONS, PSEUDOMONAS PNEUMONIA WITH RESPIRATORY FAILURE, ACUTE KIDNEY INJURY (AKI) REQUIRING RENAL REPLACEMENT THERAPY (RRT), OROPHARYNGEAL BLEEDING, AND THROMBOCYTOPENIA. AFTER WATCHFUL MONITORING AND SERIAL SCANS, IT WAS DETERMINED THAT CHANCES OF MEANINGFUL LONG-TERM COGNITIVE RECOVERY FROM A NEUROLOGIC STANDPOINT WERE POOR. THERE WERE NO REPORTED CHANGES TO THE PATIENT'S ANTICOAGULATION THAT COULD'VE CONTRIBUTED. SYMPTOMS INCLUDED HAVING NO MEANINGFUL RESPONSE. PALLIATIVE CARE WAS CONTINUED. THE DEATH WAS NOT CONSIDERED DEVICE RELATED. THE DEVICE OPERATED AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2209411 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US L00001108 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Death| H| L