BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)

    MDR report key: 17514661 · Received August 11, 2023

    Report

    Report Number
    2916596-2023-05658
    Event Type
    Death
    Date Received
    August 11, 2023
    Date of Event
    March 16, 2020
    Report Date
    October 6, 2023
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011224
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE (HM) II LEFT VENTRICLE ASSIST SYSTEM (LVAS) (SERIAL NUMBER: (B)(6), AND THE PATIENT'S OUTCOME COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. IT WAS REPORTED THAT THE PATIENT EXPIRED DUE TO RIGHT HEART FAILURE. THE PATIENT REPORTEDLY HAD SEVERE ACUTE ON CHRONIC RIGHT HEART FAILURE AND WAS MAXIMALLY SUPPORTED BY THE LVAS. NO AUTOPSY WAS PERFORMED, AND THE DEVICE WAS NOT EXPLANTED FOR EVALUATION. THERE WERE NO NOTABLE EVENTS OR ALARMS ACTIVE IN THE SUBMITTED LOG FILES. THE DEVICE APPEARED TO FUNCTION AS INTENDED. THE RELEVANT SECTION OF THE DEVICE HISTORY RECORDS WERE REVIEWED FOR THE LVAS (SERIAL NUMBER: (B)(6), AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HMII LVAS INSTRUCTIONS FOR USE (IFU) LISTS POTENTIAL ADVERSE EVENTS, INCLUDING RIGHT HEART FAILURE AND DEATH, THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. SECTION 6, UNDER "POSTOPERATIVE PATIENT CARE", CAUTIONS: "RIGHT HEART FAILURE CAN OCCUR FOLLOWING IMPLANTATION OF THE PUMP. 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 "RIGHT HEART FAILURE", DISCUSSES THE POTENTIAL DEVELOPMENT OF RIGHT HEART FAILURE DURING USE OF THE HEARTMATE II LVAS AND OUTLINES THE ASSOCIATED TREATMENT OPTIONS. 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 WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH THE PATIENT OUTCOME, THE PATIENT PASSED AWAY DUE TO RIGHT HEART FAILURE. THE PATIENT HAD ACUTE ON CHRONIC HEART FAILURE BUT DID NOT SPECIFICALLY STATE RIGHT OR LEFT. ECHOCARDIOGRAM (ECHO) ON 09JAN2012 SHOWED THE RIGHT VENTRICLE WAS ENLARGED AT 5.3CM. THERE WAS A PACEMAKER LEAD IN THE RIGHT VENTRICLE. THE RIGHT VENTRICULAR SYSTOLIC FUNCTION WAS NORMAL. THE PATIENT WAS MAXIMALLY SUPPORTED BY LVAD ON CURRENT SETTINGS WHICH WERE NOT ENOUGH TO UNLOAD LEFT VENTRICLE OR RIGHT VENTRICLE. THERE WAS NO INDICATION TO CHANGE TO VAD SPEED AT THIS TIME AS SPEED INCREASES HAVE NOT HELPED. TRANSITIONING TO CHIEF MEDICAL OFFICER (CMO) WAS DONE. AN AUTOPSY WAS NOT PERFORMED. THE DEVICE WAS NOT EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    869769 HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS) VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106015 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Death