BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 21179511 · Received January 17, 2025

    Report

    Report Number
    2916596-2025-00365
    Event Type
    Injury
    Date Received
    January 17, 2025
    Date of Event
    October 1, 2021
    Report Date
    January 17, 2025
    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

    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. TIBREWALA, A., CHUZI, S., WU, T., BALDRIDGE, A. S., HARAP, R., BRYNER, B., . . . WILCOX, J. E. (2024). IMPACT OF HEART TRANSPLANT ALLOCATION CHANGE ON WAITLIST MORTALITY AND POSTTRANSPLANT MORTALITY IN PATIENTS WITH LEFT VENTRICULAR ASSIST DEVICES. CIRCULATION.HEART FAILURE, 17(11), E011621. DOI:HTTP://DX.DOI.ORG/10.1161/CIRCHEARTFAILURE.124.011621. DIVISION OF CARDIOLOGY, DEPARTMENT OF MEDICINE (A.T., S.C., J.E.W.), NORTHWESTERN UNIVERSITY, CHICAGO, IL. DIVISION OF CARDIAC SURGERY, DEPARTMENT OF SURGERY (T.W., A.S.B., R.H., B.B., D.T.P.), NORTHWESTERN UNIVERSITY, CHICAGO, IL. MANUFACTURER'S INVESTIGATION CONCLUSION: THE SERIAL NUMBERS OF THE HEARTMATE 3 LEFT VENTRICULAR SYSTEMS IN USE WERE NOT PROVIDED. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM INSTRUCTIONS FOR USE, REVISION B IS 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 ¿IMPACT OF HEART TRANSPLANT ALLOCATION CHANGE ON WAITLIST MORTALITY AND POSTTRANSPLANT MORTALITY IN PATIENTS WITH LEFT VENTRICULAR ASSIST DEVICES¿ THAT VIEWED THE EFFECT ON WAITLIST MORTALITY RATE THAT THE CHANGES TO THE HEART TRANSPLANT ALLOCATION SYSTEM HAD ON LEFT VENTRICULAR ASSIST DEVICE (LVAD) PATIENTS. THERE WAS A TOTAL OF 4,406 LVAD PATIENTS BETWEEN OCTOBER 2016 AND OCTOBER 2021 LOOKED AT THAT WERE DIVIDED INTO TWO GROUPS, LISTING GROUP AND TRANSPLANT GROUP. PATIENTS COULD BE IN EITHER OR BOTH GROUPS. THE LISTING GROUP CONTAINED 3,835 PATIENTS (1,232 WERE THE OLD LISTING COHORT AND 2,603 WERE THE NEW LISTING COHORT) AND THE TRANSPLANT GROUP CONTAINED 3,486 PATIENTS. OF NOTE THERE WERE 3 LVAD DEVICES IN THE STUDY HEARTWARE HVAD, HEARTMATE II AND HEARTMATE 3. OF THE LISTING GROUP 1,515 PATIENTS HAD HEARTMATE 3 AND IN THE TRANSPLANT GROUP 891 PATIENTS HAD HEARTMATE 3. THE WAITLIST MORTALITY RATES WERE 50 DEATHS FOR THE OLD LISTING COHORT AND 87 DEATHS FOR THE NEW LISTING COHORT. LVAD BRAND WAS SIGNIFICANTLY ASSOCIATED WITH WAITLIST MORTALITY (OVERALL P=0.004). COMPARED WITH PATIENTS WITH HEARTMATE II, PATIENTS WITH HEARTMATE 3 HAD A SIGNIFICANTLY LOWER RISK OF WAITLIST MORTALITY (HR, 0.38 95% CI, 0.21¿0.69]; P=0.002).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1141399 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT Ventricular (assist) bypass DSQ THORATEC CORPORATION 106524US 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention