BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 19541729 · Received June 14, 2024

    Report

    Report Number
    2916596-2024-03819
    Event Type
    Death
    Date Received
    June 14, 2024
    Date of Event
    May 1, 2024
    Report Date
    July 1, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION B3: CORRECTED EVENT DATE. SECTION B5: REWRITTEN FOR CLARITY. MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LVAS (LEFT VENTRICULAR ASSIST SYSTEM), SERIAL NUMBER (B)(6), THE REPORTED PATIENT OUTCOME, AND THE EVENTS LEADING UP TO THE PATIENT OUTCOME CANNOT BE CONCLUSIVELY DETERMINED THROUGH THIS INVESTIGATION. IT WAS COMMUNICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS PROPERLY DISPOSED OF. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR MLP-042685 WERE REVIEWED AND SHOWED NO DEVIATION FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM INSTRUCTIONS FOR USE, REV. C, IS CURRENTLY AVAILABLE AND CONTAINS THE FOLLOWING INFORMATION: SECTION 1 OUTLINES POTENTIAL ADVERSE EVENTS, INCLUDING MULTIPLE TYPES OF ORGAN FAILURE, BLEEDING, STROKE, AND DEATH, THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. SECTION 6 PROVIDES INFORMATION REGARDING THE RECOMMENDED ANTICOAGULATION REGIMEN, INCLUDING INTERNATIONAL NORMALIZED RATIO (INR) VALUES, AS WELL AS SUGGESTED ANTICOAGULATION MODIFICATIONS IN THE EVENT THERE IS A RISK OF BLEEDING. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS PLACED ON VENO-ARTERIAL (VA) EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) ON (B)(6) 2024 AND HAD A HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE (LVAD) IMPLANTATION ON (B)(6) 2024. THE POSTOPERATIVE COURSE WAS COMPLICATED BY MULTISYSTEM ORGAN FAILURE, REQUIRING CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) AND PROLONGED MECHANICAL VENTILATOR SUPPORT. THE PATIENT HAD SHOCK LIVER AND MULTIPLE AREAS OF CEREBROVASCULAR ACCIDENT INVOLVING THE RIGHT MIDDLE CEREBRAL ARTERY, RIGHT FRONTAL AREA, LEFT CEREBELLAR AREA AND LEFT LATERAL POSTERIOR. GIVEN POOR PROGNOSIS, PALLIATIVE CARE WAS CONSULTED FOR END-OF-LIFE DISCUSSIONS. THE PATIENT WAS MADE A DO NOT RESUSCITATE (DNR). AFTER FAMILY DISCUSSIONS WITH PALLIATIVE CARE AND HOSPICE, THE FAMILY DECIDED TO STOP ALL LIFE SUSTAINING DEVICES AND PROCEED WITH COMFORT CARE ONLY. CRRT WAS STOPPED. THE PATIENT WAS TERMINALLY EXTUBATED AND PLACED ON NASAL CANNULA FOR COMFORT. THE LVAD WAS DISCONNECTED ON 15MAY2024 AT 1940. INTRAVENOUS FENTANYL INFUSING WITH ADDITIONAL MEDICATIONS FOR COMFORT WERE PROVIDED AS NEEDED. THE FAMILY REMAINED AT BEDSIDE UNTIL THE PATIENT PASSED AWAY DUE TO MULTI-SYSTEM ORGAN FAILURE AT 12:30AM ON (B)(6) 2024.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS PLACED ON VENOARTERIAL (VA) EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) ON (B)(6) 2024 AND HAD A HEARMATE 3 LEFT VENTRICULAR ASSIST DEVICE(LVAD) IMPLANTATION ON (B)(6) 2024. THE POST OPERATIVE COURSE WAS COMPLICATED BY MULTISYSTEM ORGAN FAILURE, REQUIRING CONTINUOUS RENAL REPLACEMENT THERAPY, PROLONGED MECHANICAL VENTILATOR SUPPORT, SHOCK LIVER AND MULTIPLE AREAS OF CEREBROVASCULAR ACCIDENT INVOLVING THE RIGHT MIDDLE CEREBRAL ARTERY, RIGHT FRONTAL AREA, LEFT CEREBELLAR AREA AND LEFT LATERAL POSTERIOR. GIVEN POOR PROGNOSIS, PALLIATIVE CARE WAS CONSULTED FOR END-OF-LIFE DISCUSSIONS. THE PATIENT WAS MADE AN DO NOT RESUSCITATE(DNR). AFTER FAMILY DISCUSSIONS WITH PALLIATIVE CARE AND HOSPICE, THE FAMILY DECIDED TO STOP ALL LIFE SUSTAINING DEVICES AND PROCEED WITH COMFORT CARE ONLY. CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) WAS STOPPED. THE PATIENT WAS TERMINALLY EXTUBATED AND PLACED ON NASAL CANNULA FOR COMFORT. LVAD WAS DISCONNECTED (B)(6) 2024 AT 1940. INTRAVENOUS FENTANYL GLUCOSE TOLERANCE TEST INFUSING WITH ADDITIONAL MEDICATIONS FOR COMFORT AS NEEDED. THE FAMILY REMAINED AT BEDSIDE UNTIL THE PASSED AWAY DUE TO MULTI-SYSTEM ORGAN FAILURE AT 12:30A.M ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795870 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 10280022 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Male Death| O