BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 21480241 · Received February 27, 2025

    Report

    Report Number
    2916596-2025-01139
    Event Type
    Injury
    Date Received
    February 27, 2025
    Date of Event
    December 1, 2018
    Report Date
    March 21, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS A AND D: SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE. DEVICE WAS IMPLANTED AT TIME OF EVENT. DEPARTMENT OF ANESTHESIOLOGY, DIVISION OF CARDIOTHORACIC ANESTHESIA, NEW YORK PRESBYTERIAN WEILL CORNELL MEDICAL CENTER, NEW YORK, NY; DEPARTMENT OF ANESTHESIOLOGY, WEILL CORNELL MEDICINE, NEW YORK, NY; DEPARTMENT OF ANESTHESIOLOGY, DIVISION OF OBSTETRIC ANESTHESIA, NEW YORK PRESBYTERIAN WEILL CORNELL MEDICAL CENTER, NEW YORK, NY. JONES, M., TANGEL, V., WHITE, R. S., & RONG, L. (2024). THE IMPACT SCORE: DOES SEX MATTER? JOURNAL OF CARDIOTHORACIC AND VASCULAR ANESTHESIA, 38(11), 2576-2581. DOI: HTTP://DX.DOI.ORG/10.1053/J.JVCA.2024.07.005. 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) AND THE EVENTS LEADING TO THE REPORTED TRANSPLANTS COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. NO PRODUCT WAS RETURNED FOR EVALUATION. THE SERIAL NUMBER OR OTHER IDENTIFYING INFORMATION OF THE PRODUCT WAS NOT REPORTED AND WAS NOT ABLE TO BE DETERMINED DURING THE INVESTIGATION. THE HEARTMATE 3 LVAS IFU AND THE HEARTMATE 3 PATIENT HANDBOOK ARE CURRENTLY AVAILABLE. ALTHOUGH NO DEVICE RELATED ISSUES WERE REPORTED BY THE ACCOUNT, THE IFU LISTS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. 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 RESEARCH ARTICLE "THE IMPACT SCORE: DOES SEX MATTER?" THAT THE HEARTMATE 3 IS ASSOCIATED WITH ORTHOTOPIC HEART TRANSPLANT (OHT). THIS MULTICENTER RETROSPECTIVE STUDY EVALUATED 20,921 PATIENTS WHO UNDERWENT A FIRST-TIME (OHT) BETWEEN JAN2009 AND DEC2018. 27% (5,411) OF THE STUDY POPULATION WERE WOMEN. IN THE STUDY WOMEN WERE YOUNGER THAN MEN WITH A MEDIAN AGE OF 54 COMPARED TO 57. WOMEN HAD HIGHER RATES OF IDIOPATHIC (38.1% V 34.9%, P < 0.001) AND CONGENITAL HEART DISEASE (4.3% V 2.4%; P < 0.001) AS THE ETIOLOGY OF THEIR HEART FAILURE. MEN HAD HIGHER RATES OF ISCHEMIC HEART DISEASE AS THEIR HEART FAILURE ETIOLOGY (37.7% V 16.7%; P < 0.001) WITH HIGHER RATES OF HYPERTENSION (33.4% V 27.1%; P < 0.001) AND DIABETES (29.2% V 22.5%; P < 0.001). OF THE TOTAL STUDY POPULATION (20,921) THAT WAS TRANSPLANTED, 28.9% (6,051) OF THE PATIENTS HAD A HEARTMATE 2 OR HEARTMATE 3, WITH 1,098 OF THOSE PATIENTS BEING WOMEN AND THE REMAINING 4,953 PATIENTS BEING MEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660567 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention