BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 21529159 · Received March 5, 2025

    Report

    Report Number
    2916596-2025-01561
    Event Type
    Injury
    Date Received
    March 5, 2025
    Date of Event
    January 1, 2022
    Report Date
    March 26, 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

    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. VINCENT, J., YANG, B. Q., DEYCH, E., & VADER, J. (2024). PREDICTIVE ACCURACY OF HEARTMATE 3 RISK SCORE AFTER HEART TRANSPLANT ALLOCATION CHANGE. JOURNAL OF CARDIAC FAILURE, 30(1), 172¿173. HTTPS://DOI.ORG/10.1016/J.CARDFAIL.2023.10.136. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    SECTION E CORRECTIONS: E1 REPORTER INFORMATION UPDATED, E2 HEALTH PROFESSIONAL CORRECTED, E3 OCCUPATION CORRECTED. SECTION G CORRECTION: G2 REPORT SOURCE CORRECTION. MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE HEARTMATE 3 DEVICES AND THE REPORTED OUTCOMES COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE RESEARCH ARTICLE TITLED ¿PREDICTIVE ACCURACY OF HEARTMATE 3 RISK SCORE AFTER THE HEART TRANSPLANT ALLOCATION CHANGE¿ WAS RECEIVED. THE HEARTMATE 3 DEVICE SERIAL NUMBERS, AS WELL AS OTHER SPECIFIC CASE/PATIENT INFORMATION, ARE NOT AVAILABLE. THE SERIAL NUMBER OR OTHER IDENTIFYING INFORMATION OF THE PRODUCT WAS NOT REPORTED AND WAS NOT ABLE TO BE DETERMINED DURING THE INVESTIGATION. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. SECTION 1, ¿INTRODUCTION¿, LISTS POTENTIAL ADVERSE EVENTS 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH THE RESEARCH ARTICLE ¿PREDICTIVE ACCURACY OF HEARTMATE 3 RISK SCORE AFTER THE HEART TRANSPLANT ALLOCATION CHANGE¿ THAT HEARTMATE 3 (HM3) MAY BE ASSOCIATED WITH TRANSPLANT, PUMP EXCHANGE/EXPLANT, AND DEATH. THIS WAS A MULTICENTER RETROSPECTIVE ANALYSIS OF CONTEMPORARY HM3 RECIPIENTS. THE UNITED NETWORK FOR ORGAN SHARING (UNOS) REVISED ITS DONOR HEART ALLOCATION SYSTEM ON (B)(6) 2018 TO REDUCE WAITLIST MORTALITY AND IMPROVE ORGAN DISTRIBUTION EQUITY. SINCE THEN, THERE HAD BEEN A DRASTIC INCREASE IN TEMPORARY MECHANICAL CIRCULATORY SUPPORT DEVICES AND A CONCURRENT DECREASE IN DURABLE LVAD USE AS A BRIDGE-TO-TRANSPLANT STRATEGY. ADULT PATIENTS WHO RECEIVED HM3 AS INITIAL IMPLANTATION BETWEEN 2015 AND 2022 AT TWO ACADEMIC MEDICAL INSTITUTIONS (N = 315) WERE ANALYZED. PARTICIPANTS IN THE MOMENTUM 3 CLINICAL TRIAL WERE INCLUDED. PATIENTS WHO UNDERWENT PREEMPTIVE RIGHT VENTRICULAR (RV) ASSIST DEVICE IMPLANT IN A CONCURRENT STUDY (N = 17) AND THOSE WITH INSUFFICIENT DATA (N = 56) WERE EXCLUDED. PATIENTS WERE CHARACTERIZED BY THEIR HM3RS AS LOW (<2.41), MEDIUM (2.41¿2.97), OR HIGH (>2.97) RISK. PATIENTS IN THIS STUDY UNDERWENT TRANSPLANT, PUMP EXCHANGE/EXPLANT, OR DEATH. THE PRIMARY OUTCOME WAS DEATH AT 1 AND 2 YEARS, STRATIFIED BY THOSE WHO RECEIVED HM3 BEFORE AND AFTER THE HEART TRANSPLANT ALLOCATION CHANGE. THE OVERALL INCIDENCE OF DEATH IN THIS STUDY¿S COHORT AT 1 AND 2 YEARS WAS 17.4% AND 22.3%, RESPECTIVELY. IN COMPARISON, THE 1- AND 2-YEAR MORTALITY IN MOMENTUM 3 WERE 13% AND 18.2%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448199 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| O