BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 21161113 · Received January 15, 2025

    Report

    Report Number
    2916596-2025-00256
    Event Type
    Injury
    Date Received
    January 15, 2025
    Date of Event
    October 18, 2020
    Report Date
    January 15, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    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. FROM THE *DEPARTMENT OF INTERNAL MEDICINE, CLEVELAND CLINIC FOUNDATION, CLEVELAND, OHIO; ¿DEPARTMENT OF BIOSTATISTICS, UNIVERSITY OF WASHINGTON, SEATTLE, WASHINGTON; ¿DEPARTMENT OF INTERNAL MEDICINE, UNIVERSITY OF MIAMI MILLER SCHOOL OF MEDICINE, PALM BEACH CAMPUS, ATLANTIS, FLORIDA; AND §DIVISION OF CARDIOLOGY, DEPARTMENT OF INTERNAL MEDICINE, UNIVERSITY OF WASHINGTON MEDICAL CENTER, SEATTLE, WASHINGTON. BRAGHIERI, L., ET AL. (2024). THE IMPACT OF THE 2018 ALLOCATION SYSTEM CHANGE ON PATIENTS BRIDGED WITH DURABLE LEFT VENTRICULAR ASSIST DEVICE: AN UPDATED UNOS REGISTRY ANALYSIS. ASAIO JOURNAL, 70(5), 456¿459. HTTPS://DOI.ORG/10.1097/MAT.0000000000002115. THE REPORTABLE AWARE DATE IS THE DATE THE SJM NOTIFIER COMPLETED READING THE ARTICLE AND ENTERED IN THE COMPLAINT DATABASE. 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 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. ALTHOUGH NO DEVICE RELATED ISSUES WERE REPORTED BY THE ACCOUNT, THE IFU LISTS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. THE SERIAL NUMBERS OF THE HEARTMATE 3 LEFT VENTRICULAR SYSTEMS IN USE WERE NOT PROVIDED. 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 "THE IMPACT OF THE 2018 ALLOCATION SYSTEM CHANGE ON PATIENTS BRIDGED WITH DURABLE LEFT VENTRICULAR ASSIST DEVICE (LVAD): AN UPDATED UNOS REGISTRY ANALYSIS" THAT THE HEARTMATE 3 (HM3) PATIENTS EXPERIENCED HEART TRANSPLANT (HT) AND WAITLIST MORTALITY. OF NOTE, PATIENTS IMPLANTED WITH HEARTMATE II AND HEARTWARE WERE INCLUDED IN THE ANALYSIS. THIS ARTICLE LEVERAGED THE UNITED NETWORK FOR ORGAN SHARING (UNOS) REGISTRY TO MEASURE THE IMPACT OF THE 2018 ALLOCATION SYSTEM CHANGE (ASC) PRIMARILY BY OBSERVING 1 YEAR POST HT MORTALITY PRIMARILY, AND SECONDARILY, WAITLIST MORTALITY AND HEART TRANSPLANT RATES. RESULTS FOUND THAT ALTHOUGH LISTING POST-ASC WAS ASSOCIATED WITH HIGHER HT RATES, THE LIKELIHOOD OF HT WAS LOWER AMONG PATIENTS WITH VS WITHOUT LVAD IN THE POST-ASC: HAZARD RATIO (HR) 0.97 VS POST-ASC: HR 0.75 PINTERACTION <0.001. LVAD DEVICE SUPPORT WAS ASSOCIATED WITH LOWER HAZARD OF WAITLIST DEATH AT 1 YEAR FOLLOW UP IN BOTH ERAS, BUT THE SURVIVAL BENEFIT FROM LVAD SUPPORT TWAS SIGNIFICANTLY LOWER IN THE POST-ASC PERIOD (PRE-ASC: HR, 0.28 VS. POST-ASC: HR, 0.55; P INTERACTION = 0.006). ONE YEAR POST-HT MORTALITY WAS NOT DIFFERENT BETWEEN PATIENTS WITH VERSUS WITHOUT LVAD IN THE PRE-ASC ERA (HR, 1.19; P = 0.11, TABLE 1), WHEREAS IT WAS 58% HIGHER AMONG PATIENTS WITH VERSUS WITHOUT LVAD AFTER THE ASC (HR, 1.58; P < 0.001; PINTERACTION = 0.043).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1299855 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT Ventricular (assist) bypass DSQ THORATEC CORPORATION 106524US 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other