BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 17475605 · Received August 7, 2023

    Report

    Report Number
    2916596-2023-05590
    Event Type
    Death
    Date Received
    August 7, 2023
    Date of Event
    June 26, 2023
    Report Date
    September 18, 2023
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    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

    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 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 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) (REV. C) IS CURRENTLY AVAILABLE. SECTION 1 ¿INTRODUCTION¿ OF THIS DOCUMENT LISTS CARDIAC ARRHYTHMIA, BLEEDING, RIGHT HEART FAILURE, AND DEATH AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS. ADDITIONALLY, SECTION 6 ¿PATIENT CARE AND MANAGEMENT¿ LISTS ARRHYTHMIA AS A POTENTIAL LATE POSTIMPLANT COMPLICATION THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LVAS. SECTION 6, ¿PATIENT CARE AND MANAGEMENT¿ (UNDER ¿RIGHT HEART FAILURE), STATES THAT PATIENTS MAY DEVELOP RIGHT VENTRICULAR FAILURE DURING OR SHORTLY AFTER IMPLANT AND OUTLINES THE ASSOCIATED TREATMENT OPTIONS. SECTION 6 (UNDER ¿CAUTION!¿) FURTHER EXPLAINS THAT RIGHT VENTRICULAR DYSFUNCTION, ESPECIALLY WHEN COMBINED WITH ELEVATED PULMONARY VASCULAR RESISTANCE, MAY LIMIT THE EFFECTIVENESS OF THE LEFT VENTRICULAR ASSIST SYSTEM DUE TO REDUCED FILLING OF THE PUMP. SECTION 6 (UNDER "ANTICOAGULATION") OUTLINES THE RECOMMENDED ANTICOAGULATION REGIMEN (INCLUDING INR RANGE) FOR PATIENTS USING THE HEARTMATE 3 LVAS AS WELL AS THE SUGGESTED ANTICOAGULATION MODIFICATIONS IN THE EVENT THAT THERE IS A RISK OF BLEEDING. 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 ADMITTED ON (B)(6) 2023 DUE TO CARDIOGENIC SHOCK SECONDARY TO VENTRICULAR TACHYCARDIA (VT) ARREST. THE PATIENT WAS GIVEN NUMEROUS SHOCKS WITH AN EXTERNAL DEFIBRILLATOR. THE PATIENT'S VT WAS NOTED TO BE A PRE-EXISTING CONDITION PRIOR TO THEIR LEFT VENTRICULAR ASSIST DEVICE (LVAD) IMPLANT. AMIODARONE AND LIDOCAINE WAS ADMINISTERED, AND THE PATIENT WAS CANNULATED WITH A VENOATERIAL EXTRACORPOREAL MEMBRANE OXYGENATOR (VA-ECMO) FOR EXTRACORPOREAL CARDIOPULMONARY RESUSCITATION (ECPR). STELLATE GANGLION BLOCKS WERE ADMINISTERED ON (B)(6) 2023. THE PATIENT'S COURSE CONTINUED TO BE COMPLICATED BY PERSISTENT VASOPLEGIA AND RIGHT VENTRICULAR FAILURE; THE PATIENT WAS UNABLE TO WEAN FROM THEIR VA-ECMO. THE PATIENT'S RIGHT VENTRICULAR FAILURE WAS ALSO NOTED TO BE A PRE-EXISTING CONDITION PRIOR TO THEIR LVAD IMPLANT. THE PATIENT ALSO DEVELOPED AN ACUTE GASTROINTESTINAL (GI) BLEED. THE PATIENT'S FAMILY DECIDED TO TRANSITION THE PATIENT TO COMFORT MEASURES, AND THE PATIENT ULTIMATELY PASSED AWAY ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319189 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 9013070 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Death