BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 21621437 · Received March 17, 2025

    Report

    Report Number
    2916596-2025-01763
    Event Type
    Injury
    Date Received
    March 17, 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: THIS REPORT IS BEING SPLIT OFF FROM THE INITIALLY SUBMITTED REPORT (MANUFACTURER REPORT NUMBER: 2916596-2025-00884) TO INVESTIGATE THIS EVENT UNDER 2 PRODUCTS. SECTIONS A AND D: SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. DEVICE WAS IMPLANTED AT TIME OF EVENT. SECTION B2: SPECIFIC DEATH DATE IS DOCUMENTED AS UNKNOWN. 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. MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) AND THE REPORTED EVENTS 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 (IFU), IS CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS POTENTIAL ADVERSE EVENTS, INCLUDING RENAL FAILURE, THAT MAY BE ASSOCIATED WITH THE USE OF 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 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
    1211159 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT Ventricular (assist) bypass DSQ THORATEC CORPORATION 106524US 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| R