BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 21314319 · Received February 5, 2025

    Report

    Report Number
    2916596-2025-00501
    Event Type
    Death
    Date Received
    February 5, 2025
    Date of Event
    January 1, 2014
    Report Date
    February 5, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A, D: SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. SECTION B3: DATE OF EVENT HAS BEEN ENTERED AS 01JAN2014 AS THE IMPLANT DATES OCCURRED BETWEEN 2014-2021. AUTHOR INFORMATION: PIENTA, M., PEGUES, J., CASCINO, T., COWGER, J., ROSENBAUM, A., HAWKINS, R., COLVIN, M., AARONSON, K., YANG, J., LIKOSKY, D., PAGANI, F., & TANG, P. (2024). INTERMACS ANALYSIS OF IMPACT OF SIGNIFICANT POST-LVAD MITRAL REGURGITATION ON OUTCOMES. THE JOURNAL OF HEART AND LUNG TRANSPLANTATION, 43(4), S136¿S137. HTTPS://DOI.ORG/10.1016/J.HEALUN.2024.02.277. CARDIAC SURGERY, UNIVERSITY OF MICHIGAN- ANN ARBOR, ANN ARBOR, MI; UNIVERSITY OF MICHIGAN, ANN ARBOR, MI; INTERNAL MEDICINE, HENRY FORD HOSPITALS, DETROIT, MI; 4INTERNAL MEDICINE, MAYO CLINIC, ROCHESTER, MN; UNIVERSITY OF MICHIGAN-ANN ARBOR, ANN ARBOR, MI; 6UNIVERSITY OF MICHIGAN HEALTH SYSTEM, ANN ARBOR, MN; INTERNAL MEDICINE, UNIV OF MICHIGAN MED CTR, ANN ARBOR, MI; CARDIAC SURGERY, UNIVERSITY OF MICHIGAN, ANN ARBOR, MI; MAYO CLINIC, ROCHESTER, MN. MANUFACTURER¿S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEMS (LVAS) AND THE REPORTED EVENTS COULD NOT CONCLUSIVELY BE ESTABLISHED THROUGH THIS EVALUATION. THE SERIAL NUMBERS OF THE HEARTMATE 3 LEFT VENTRICULAR SYSTEMS IN USE WERE NOT PROVIDED. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), REVISION B, IS CURRENTLY AVAILABLE. SECTION 1 OF THIS DOCUMENT LISTS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS, INCLUDING DEATH. 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 TITLED ¿INTERMACS ANALYSIS OF IMPACT OF SIGNIFICANT POST-LVAD MITRAL REGURGITATION ON OUTCOMES¿ THAT HEARTMATE 3 (HM3) IMPLANT IS ASSOCIATED WITH OUTCOMES SUCH AS POST IMPLANT MITRAL VALVE REGURGITATION (PI-MR) AND DEATH. THE INTERMACS DATABASE WAS QUERIED TO IDENTIFY 7,385 PATIENTS RECEIVING PRIMARY HEARTMATE 3 IMPLANT FROM 2014-2021. PATIENTS UNDERGOING CONCOMITANT MITRAL VALVE PROCEDURES WERE EXCLUDED. SIGNIFICANT PIMR FOLLOWING LVAD IMPLANT WAS DEFINED AS MODERATE/SEVERE MITRAL REGURGITATION (MR) POST-IMPLANT ON 1 OR 3-MONTH ECHOCARDIOGRAM. THOSE NOT SURVIVING 3 MONTHS (N=682) AND/OR WITHOUT ECHOCARDIOGRAM RESULTS AVAILABLE (N=781) WERE EXCLUDED. SURVIVAL AND READMISSION ANALYSIS USING LOG-RANK STATISTICS WERE CONDITIONAL ON 3 MONTH SURVIVAL. THE STUDY COHORT CONSISTED OF 363 PATIENTS WITH SIGNIFICANT PI-MR AND 2,744 PATIENTS WITHOUT SIGNIFICANT PI-MR. OF THOSE WITH PREOPERATIVE SIGNIFICANT MR, 17% (N=292) HAD PERSISTENT SIGNIFICANT PI-MR. FOR THOSE WITH MILD OR LESS PRE-IMPLANT MR, 5% (N=71) DEVELOPED NEW SIGNIFICANT PI-MR. PATIENTS WITH SIGNIFICANT PI-MR HAD WORSE SURVIVAL AT 2 YEARS, CONDITIONAL UPON SURVIVING 3 MONTHS (80% VS 87%, P=0.024) AND FREEDOM FROM ALL-CAUSE READMISSIONS (27% VS 36%, P=0.03). SIGNIFICANT PI-MR ALSO PREDICTED WORSE CONDITIONAL MORTALITY BASED ON LOG-RANK STATISTICS (P=0.012) AND INCREASED READMISSIONS (P=0.004). THOSE PATIENTS WITH SIGNIFICANT PI-MR WERE MORE LIKELY TO HAVE RECEIVED CONCOMITANT TRICUSPID VALVE SURGERY (17% VS 10%, P < 0.001). SIGNIFICANT RESIDUAL MR FOLLOWING LVAD ADVERSELY IMPACTS 2-YEAR SURVIVAL AND ALL-CAUSE READMISSIONS. THESE DATA SUGGEST THAT STRATEGIES TO REDUCE THE OCCURRENCE OF PI-MR MAY IMPROVE DURABLE LVAD OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61711 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT Ventricular (assist) bypass DSQ THORATEC CORPORATION 106524US 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death