BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 21332708 · Received February 7, 2025

    Report

    Report Number
    2916596-2025-00884
    Event Type
    Death
    Date Received
    February 7, 2025
    Date of Event
    January 1, 2022
    Report Date
    March 17, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: E2, E3, G2 MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) AND THE REPORTED PATIENT OUTCOMES COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. NO PRODUCT WAS EVALUATED UNDER THIS COMPLAINT. THE HEARTMATE 3 DEVICE SERIAL NUMBERS, AS WELL AS OTHER SPECIFIC CASE/PATIENT INFORMATION, ARE NOT AVAILABLE. A REVIEW OF THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED AS THE SERIAL NUMBER OF THE DEVICE WAS NOT COMMUNICATED/IDENTIFIED. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE IS CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, "INTRODUCTION", LISTS POTENTIAL ADVERSE EVENTS, INCLUDING DEATH, 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.

    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. SECTION B2: SPECIFIC DEATH DATE IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ARTICLE SECTION B3: DATE OF EVENT HAS BEEN ENTERED AS 01JAN2022 AS PATIENTS WERE IMPLANTED BETWEEN 2015 AND 2022. AUTHOR INFORMATION: GENUARDI, M., ZHAO, M., MOSS, N., RADAKRISHNAN, A., KILIC, A., WELCH, B., SAEED, O., MENDAPARA, P., JAWAID, A., SHAH, S., MARECKI, G., MOIN, D., CHAWLA, S., MEHTA, M., ATLURI, P., & VIDULA, H. (2024). PERI-IMPLANT RENAL REPLACEMENT THERAPY AND MORTALITY IN A CONTEMPORARY MULTICENTER REGISTRY OF HEARTMATE 3 LVAD RECIPIENTS. THE JOURNAL OF HEART AND LUNG TRANSPLANTATION, 43(4), S396. HTTPS://DOI.ORG/10.1016/J.HEALUN.2024.02.1280. UNIVERSITY OF PENNSYLVANIA, PHILADELPHIA, PA; MOUNT SINAI HOSPITAL, NEW YORK, NY; MEDICAL UNIVERSITY OF SOUTH CAROLINA, CHARLESTON, SC; MONTEFIORE MEDICAL CTR, NEW YORK, NY; UT SOUTHWESTERN, DALLAS, TX; NORTHWELL, NEW YORK, NY; NORTHWELL HEALTH, NEW YORK, NY; NYU LANGONE HEALTH, NEW YORK, NY; ROBERT WOOD JOHNSON, NEW BRUNSWICK, NJ; TUFTS UNIVERSITY, BOSTON, MA. THE REPORTABLE AWARE DATE IS THE DATE THE SJM NOTIFIER COMPLETED READING THE ARTICLE AND ENTERED IN THE COMPLAINT DATABASE (PER SECTION 6.3.4 OF 90979616). NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH THE RESEARCH ARTICLE "PERI-IMPLANT RENAL REPLACEMENT THERAPY AND MORTALITY IN A CONTEMPORARY MULTICENTER REGISTRY OF HEARTMATE 3 LVAD RECIPIENTS" THAT HEARTMATE 3 MAY BE ASSOCIATED WITH RENAL DYSFUNCTION AND DEATH. THE STUDY AIMED TO EXAMINE THE ASSOCIATION BETWEEN EARLY NEED RENAL REPLACEMENT THERAPY (RRT) AND LONG-TERM SURVIVAL IN A CONTEMPORARY, MULTICENTER COHORT OF PATIENTS IMPLANTED WITH A HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE STUDY INCLUDED CONSECUTIVE PATIENTS IMPLANTED WITH A HEARTMATE 3 LVAD AT 6 U.S. CENTERS BETWEEN 2015-2022 WITH DATA AVAILABLE. EARLY RRT WAS DEFINED AS RRT AT THE TIME OF LVAD IMPLANTATION OR WITHIN 1 MONTH OF IMPLANT. PATIENTS WHO DIED WITHIN 1 MONTH (N=28) WERE EXCLUDED. 496 PATIENTS (AGE 55 ± 13 YEARS, 26% FEMALE, 40% BLACK, 39% WHITE, 45% INTERMACS PROFILE 1 OR 2) WITH MEAN FOLLOW-UP OF 2.2 ± 1.6 YEARS WERE STUDIED. THIRTY-SIX (7.3%) PATIENTS MET CRITERIA FOR EARLY RRT. THERE WERE NO SIGNIFICANT DIFFERENCES IN AGE, SEX, RACE, OR INTERMACS PROFILE BETWEEN EARLY RRT AND NON-EARLY RRT PATIENTS. KAPLAN-MEIER SURVIVAL ANALYSIS SHOWED THAT EARLY RRT PATIENTS HAD SIGNIFICANTLY LOWER SURVIVAL AT 2-YEARS (65%) COMPARED TO NON-EARLY RRT PATIENTS (85%) (P=0.0038 FOR OVERALL DIFFERENCE DURING FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    918466 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death