BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 11422868 · Received March 5, 2021

    Report

    Report Number
    2916596-2021-00992
    Event Type
    Injury
    Date Received
    March 5, 2021
    Date of Event
    February 11, 2021
    Report Date
    May 1, 2023
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    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 REPORT OF RIGHT HEART FAILURE, HEMATURIA, AND NEUROLOGIC DYSFUNCTION COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. THE PATIENT REMAINS ONGOING ON (B)(6) WITH NO FURTHER RELATED ISSUES REPORTED AT THIS TIME. THE HEARTMATE 3 LVAS INSTRUCTIONS FOR USE (IFU) LISTS RIGHT HEART FAILURE, BLEEDING, AND OTHER NEUROLOGICAL EVENTS (NOT STROKE-RELATED) AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS. THE IFU OUTLINES INDICATIONS OF RIGHT HEART FAILURE AS WELL AS POSSIBLE TREATMENTS. INFORMATION REGARDING THE RECOMMENDED ANTICOAGULATION THERAPY AND INR (INTERNATIONAL NORMALIZED RATIO) RANGE CAN ALSO BE FOUND WITHIN THIS DOCUMENT, AS WELL AS CONSIDERATIONS FOR WHEN THERE IS A RISK OF BLEEDING. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE IMPLANT KIT WAS SHIPPED ON 31JAN2021. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. SECTION 1 ¿INTRODUCTION¿ OF THIS DOCUMENT LISTS RIGHT HEART FAILURE, BLEEDING, AND OTHER NEUROLOGICAL EVENTS (NOT STROKE-RELATED) AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS. ADDITIONALLY, SECTION 6 ¿PATIENT CARE AND MANAGEMENT¿ LISTS RIGHT HEART FAILURE AS A POTENTIAL RISK/ADVERSE EVENT AND NEUROLOGIC DYSFUNCTION AS A POTENTIAL LATE POSTIMPLANT COMPLICATION THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LVAS. THIS SECTION (UNDER ¿RIGHT HEART FAILURE¿) OUTLINES INDICATIONS OF RIGHT HEART FAILURE AS WELL AS POSSIBLE TREATMENTS. SECTION 6 ALSO PROVIDES INFORMATION REGARDING THE RECOMMENDED ANTICOAGULATION THERAPY AND INR (INTERNATIONAL NORMALIZED RATIO) RANGE, AS WELL AS CONSIDERATIONS FOR WHEN 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 LATER REPORTED THAT THE RIGHT HEART FAILURE RESOLVED WITHOUT SEQUALAE ON (B)(6) 2021.

    Description of Event or Problem · 0

    IT WAS ALSO REPORTED THAT THE PATIENT WAS IMPLANTED WITH A TEMPORARY RIGHT VENTRICULAR ASSIST DEVICE (RVAD) POST-SURGERY FOR SUPPORT OF RIGHT HEART FAILURE ISSUES. IT WAS REMOVED 4 DAYS LATER. THE PATIENT'S RIGHT HEART FAILURE RESOLVED (B)(6) 2021.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HAVING RIGHT HEART FAILURE STARTING ON (B)(6) 2021. THE PATIENT'S RIGHT HEART FAILURE REPORTEDLY RESOLVED WITHOUT SEQUELAE ON (B)(6) 2021. ADDITIONALLY, ON (B)(6) 2021, THE PATIENT HAD WORSENING HEMATURIA REQUIRING 2 UNITS OF PACKED RED BLOOD CELLS (PRBCS). THE PATIENT'S BLEEDING RESOLVED WITHOUT SEQUELAE ON (B)(6) 2021. ON (B)(6) 2021, THE PATIENT WAS NOTED TO HAVE A CHANGE IN PERSONALITY (I.E. WAS NOT ACTING LIKE HIMSELF) AND DYSARTHRIA WITH APHASIC EPISODES. COMPUTED TOMOGRAPHY (CT) SCANS OF THE HEAD WERE NEGATIVE FOR ACUTE PROCESS OR ISCHEMIA/HEMORRHAGE. A BEM (BOUNDARY ELEMENT METHOD) MODEL WAS ORDERED AND WAS POSITIVE FOR FOCAL SEIZURES ARISING FROM THE RIGHT FRONTOCENTRAL REGION. THE PATIENT'S MENTAL STATUS AND DYSARTHRIA HAD REPORTEDLY IMPROVED. THE PATIENT HAD NO PRIOR HISTORY OF SEIZURES, AND THE ETIOLOGY OF THEIR ONSET WAS UNCLEAR. THE PATIENT WAS STARTED ON KEPPRA (100MG) AND BEM MONITORING WOULD CONTINUE. THE PATIENT WAS STABLE AND THEIR SEIZURES RESOLVED WITHOUT SEQUELAE ON (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321817 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 7730915 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Hospitalization| R