BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 21355224 · Received February 11, 2025

    Report

    Report Number
    2916596-2025-00577
    Event Type
    Death
    Date Received
    February 11, 2025
    Date of Event
    June 1, 2023
    Report Date
    February 19, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS A AND D4: SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. DEVICE WAS IMPLANTED AT TIME OF EVENT. DATE OF EVENT IS APPROXIMATE AS THE DATA WERE COLLECTED BETWEEN FEB 2016 TO JULY 2023. MONDELLINI, G., PINSINO, A., HYNDS, M., VINOGRADSKY, A., LADANYI, A., SAYER, G., KAKU, Y., URIEL, N., TAKEDA, K., HUSAIN, S., MOHAN, S., COLOMBO, P., & YUZEFPOLSKAYA, M. (2024). CYSTATIN C-BASED ESTIMATED GLOMERULAR FILTRATION RATE IS INDEPENDENTLY ASSOCIATED WITH LONG-TERM MORTALITY IN HEARTMATE3 PATIENTS. THE JOURNAL OF HEART AND LUNG TRANSPLANTATION, 43(4), S135¿S136. HTTPS://DOI.ORG/10.1016/J.HEALUN.2024.02.275. COLUMBIA UNIVERSITY AND IRVING MEDICAL CENTER, NEW YORK, NY. 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 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) 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 ¿CYSTATIN C-BASED ESTIMATED GLOMERULAR FILTRATION RATE IS INDEPENDENTLY ASSOCIATED WITH LONG- TERM MORTALITY IN HEART MATE 3 PATIENTS¿ THAT THE HEARTMATE 3 MAY BE RELATED TO DEATH. 228 PATIENTS WERE ENROLLED IN THE STUDY FROM (AGE60 ± 13YEARS, 15% FEMALE, 21% BLACK, 43% ISCHEMIC, 58% INTERMACS PROFILE 1 OR 2). OVER A MEDIAN FOLLOW-UP OF 3 YEARS (INTERQUARTILE RANGE 1.5 TO 5), DEATH OCCURRED IN 41 (18%) PATIENTS. COMPARED TO SERUM CREATININE (SCR), CYSTATIN C (CYSC) RECLASSIFIED 61% OF THE PATIENTS TO A DIFFERENT ESTIMATED GLOMERULAR FILTRATION RATE (EGFR) CATEGORY, LEADING TO A HIGHER PREVALENCE OF EGFR <60ML/MIN/1.73 M2. EGFR WAS ASSOCIATED WITH MORTALITY ONLY WHEN ASSESSED BY CYSC (HR PER10ML/MIN/1.73M2 DECREASE IN SCR-BASED EGFR (EGFRSCR) 1.15, P=0.2 AND CYSC-BASED EGFR (EGFRCYSC) 1.44,P=0.01). THE STUDY INVESTIGATED THE ASSOCIATION OF PRE-IMPLANT EGFRSCR AND EGFRCYSC WITH LONG-TERM MORTALITY IN A COHORT OF PATIENTS IMPLANTED WITH HM3. THEY FOUND THAT LOWER PRE-IMPLANT EGFRCYSC, BUT NOT EGFRSCR, IS IN DEPENDENTLY ASSOCIATED WITH INCREASED LONG-TERM MORTALITY IN HM3 RECIPIENTS. THE FINDINGS SUGGEST THAT THIS ALTERNATIVE ESTIMATE OF KIDNEY FUNCTION IMPROVES RISK STRATIFICATION DURING ASSESSMENT OF HM3 CANDIDACY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1708665 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death