BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 14434666 · Received May 19, 2022

    Report

    Report Number
    2916596-2022-10906
    Event Type
    Death
    Date Received
    May 19, 2022
    Date of Event
    December 31, 2018
    Report Date
    May 18, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. DATE OF EVENT HAS BEEN ENTERED AS THE LAST DATE OF THE DATA COLLECTION (B)(4). ARTICLE TITLE: A TALE OF TWO CENTRIFUGAL-FLOW VENTRICULAR ASSIST DEVICES AS BRIDGE TO HEART TRANSPLANT. AUTHORS: HAZAIM ALWAIR, MD, KATHERINE WHITEHOUSE, MPH, MARK S. SLAUGHTER, MD, AND JAIMIN R. TRIVEDI, MBBS, MPH. DEPARTMENT OF CARDIOVASCULAR AND THORACIC SURGERY, UNIVERSITY OF LOUISVILLE SCHOOL OF MEDICINE, LOUISVILLE, KENTUCKY . MANUFACTURER'S INVESTIGATION CONCLUSION: A SPECIFIC CAUSE FOR THE REPORTED NEUROLOGIC EVENTS, MULTI ORGAN FAILURE, CARDIAC ARREST, AND PATIENT OUTCOME COULD NOT BE CONCLUSIVELY DETERMINED. ADDITIONALLY, A DIRECT CORRELATION BETWEEN THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY ESTABLISHED. THE SERIAL NUMBERS OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEMS ASSOCIATED WITH THE REPORTED EVENT WERE NOT PROVIDED THROUGH THE RESEARCH ARTICLE. THE HEARTMATE 3 LVAS IFU IS CURRENTLY AVAILABLE. STROKE, NEUROLOGIC EVENTS (NON-STROKE RELATED), BLEEDING, MULTIPLE ORGAN FAILURES/DYSFUNCTIONS, AND DEATH ARE LISTED AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM IN SECTION 1 OF THIS DOCUMENT. SECTION 6, ¿PATIENT CARE AND MANAGEMENT¿ ALSO PROVIDES INFORMATION REGARDING ANTICOAGULATION, INCLUDING THE RECOMMENDED INR VALUES AND SUGGESTED ANTICOAGULATION MODIFICATIONS. SECTION 6 ALSO LISTS NEUROLOGICAL DYSFUNCTION AND THROMBOEMBOLISM AS POTENTIAL POSTIMPLANT COMPLICATIONS. NO FURTHER INFORMATION PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH THE RESEARCH ARTICLE, ¿A TALE OF TWO CENTRIFUGAL-FLOW VENTRICULAR ASSIST DEVICES AS BRIDGE TO HEART TRANSPLANT,¿ THAT OUT OF 226 PATIENTS WITH A HEARTMATE 3 (HM3) LVAS, 3 EXPIRED DUE TO NEUROLOGIC CONDITIONS, 6 EXPIRED DUE TO CARDIAC EVENTS, 6 EXPIRED DUE TO MULTIORGAN FAILURE, AND 2 EXPIRED DUE TO OTHER UNREPORTED CAUSES. ADDITIONALLY, 22 PATIENTS WERE DELISTED FOR TRANSPLANT DUE TO DETERIORATION WITH NO CAUSE REPORTED. ADDITIONALLY, 3% OF HM3 LVAS PATIENTS STUDIED EXPERIENCED THROMBOSIS WHILE AWAITING TRANSPLANT. THE STUDY NOTED THAT GASTROINTESTINAL BLEEDING MAY HAVE OCCURRED, BUT WAS NOT NOTED IN THE RESULTS. ASSOCIATED MFR NUMBERS: 2916596-2022-10907 COVERS THE SERIOUS INJURIES IN THIS EVENT. 2916596-2022-10909 COVERS THE THROMBOSIS IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2095574 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death