BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 21540727 · Received March 6, 2025

    Report

    Report Number
    2916596-2025-01207
    Event Type
    Injury
    Date Received
    March 6, 2025
    Date of Event
    July 1, 2024
    Report Date
    April 24, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT HAS BEEN ESTIMATED. RUBINSTEIN, G., IZAR, B., MCDONNELL, D. E., VALLEDOR, A. F., FRIED, J. A., CLERKIN, K., LIN, E. F., LOTAN, D., LATIF, F., SAYER, G., URIEL, N., & RAIKHELKAR, J. K. (2024). RECURRENT MELANOMA 25 YEARS AFTER INITIAL DIAGNOSIS, PRESENTING AS METASTATIC DISEASE EARLY AFTER HEART TRANSPLANTATION. CARDIO-ONCOLOGY, 10(1). HTTPS://DOI.ORG/10.1186/S40959-024-00273-7. DIVISION OF CARDIOLOGY, CENTER FOR ADVANCED CARDIAC CARE, COLUMBIA UNIVERSITY IRVING MEDICAL CENTER, NEW YORK, NY, USA. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. DEVICE WAS IMPLANTED AT TIME OF EVENT. DATE OF EVENT WAS ESTIMATED. MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) AND THE REPORTED EVENTS COULD NOT CONCLUSIVELY BE ESTABLISHED THROUGH THIS EVALUATION. THE SERIAL NUMBER OF THE HEARTMATE 3 LEFT VENTRICULAR SYSTEM IN USE WERE NOT PROVIDED. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. SECTION 1 OF THIS DOCUMENT LISTS THE ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH THE CASE STUDY "RECURRENT MELANOMA 25 YEARS AFTER INITIAL DIAGNOSIS, PRESENTING AS METASTATIC DISEASE EARLY AFTER HEART TRANSPLANTATION" THAT CANCER SURVIVORS (CS) COMPRISE A PARTICULARLY HIGH-RISK GROUP FOR BOTH DE-NOVO AND RECURRENT MALIGNANCIES AFTER SOLID ORGAN TRANSPLANTATION. THIS CASE STUDY FOCUSED ON A 69-YEAR-OLD MALE WITH NON-ISCHEMIC CARDIOMYOPATHY DUE TO A SARCOMERE PROTEIN TITIN (TTN) GENE MUTATION, UNDERWENT A HEART TRANSPLANT NINE MONTHS AFTER HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE (LVAD) PLACEMENT FOR ADVANCED HEART FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435371 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male