BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 14622247 · Received June 7, 2022

    Report

    Report Number
    2916596-2022-11519
    Event Type
    Injury
    Date Received
    June 7, 2022
    Date of Event
    August 1, 2021
    Report Date
    July 25, 2022
    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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. DATE OF EVENT HAS BEEN ENTERED AS THE SAME AS PUBLISHED DATE SINCE DATE OF DATA COLLECTION WAS NOT PROVIDED. ARTICLE TITLE: THE INITIAL ANALYSIS OF INFECTIOUS ADVERSE EVENTS IN PEDIATRIC VENTRICULAR ASSIST DEVICES REPORTED TO THE ACTION REGISTRY. N. BANSAL, ET AL. THE JOURNAL OF HEART AND LUNG TRANSPLANTATION, 01 APR 2022. DOI: 10.1016/J.HEALUN.2022.01.178. ADDITIONAL MFR # 2916596-2022-11521. 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 SPECIFIC CAUSE FOR THE REPORTED INFECTIONS OR SEPSIS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION, AND A DIRECT CORRELATION BETWEEN THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. SPECIFIC SERIAL NUMBERS OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEMS WERE NOT PROVIDED, AND NO PRODUCT WAS AVAILABLE FOR EVALUATION. THE APPLICABLE SERIAL NUMBERS OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEMS ASSOCIATED WITH THE REPORTED EVENTS WERE NOT PROVIDED AND WERE UNABLE TO BE IDENTIFIED. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. SECTION 1 ¿INTRODUCTION¿ OF THIS DOCUMENT LISTS LOCALIZED INFECTION, DRIVELINE INFECTION, PUMP POCKET OR PSEUDO POCKET INFECTION AND SEPSIS AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS. ADDITIONALLY, SECTION 6 ¿PATIENT CARE AND MANAGEMENT¿ LISTS INFECTION AS A POTENTIAL LATE POSTIMPLANT COMPLICATION THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LVAS. THIS SECTION INCLUDES INFORMATION FOR CARING FOR THE DRIVELINE EXIT SITE AS WELL AS INFORMATION REGARDING HOW TO PREVENT AND CONTROL INFECTION. THE HEARTMATE 3 LVAS PATIENT HANDBOOK CONTAINS SEVERAL SECTIONS WITH INFORMATION ABOUT HOW TO PREVENT AND CONTROL INFECTION. 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 INITIAL ANALYSIS OF INFECTIOUS ADVERSE EVENTS IN PEDIATRIC VENTRICULAR ASSIST DEVICES REPORTED TO THE ACTION REGISTRY" IDENTIFYING THAT HEARTMATE 3 MAY BE RELATED TO SEPSIS, DRIVELINE INFECTION, AND PUMP INFECTION. THE CENTRIMAG DEVICE WAS ALSO IDENTIFIED. IN THIS COHORT STUDY, VAD DATA FROM THE ACTION REGISTRY FROM SEP2018 TO AUG2021 WERE ANALYZED. COHORT WAS DIVIDED BY DEVICE TYPE AS PARACORPOREAL (PC) (CENTRIMAG) AND INTRACORPOREAL (IC) (HEARTMATE 3) TO DESCRIBE INFECTION ADVERSE EVENTS (IAE). OF THE 506 PATIENTS, 139 PATIENTS (27.5%) EXPERIENCED AT LEAST ONE IAE. MAJORITY WERE SEPSIS (77, 34.5%) OR LOCALIZED NON DEVICE RELATED (77, 34.5%), 51 (22.9%) BEING IAE OF PERCUTANEOUS SITE AND ONLY 4 (1.8%) WERE PUMP RELATED. MEDIAN TIME TO FIRST DEVICE RELATED IAE WAS 40 DAYS. INFECTIONS WERE BACTERIAL IN 121 (46.5%), FUNGAL IN 10 (3.86%) AND UNKNOWN IN 119 (46%). UPON COMPARISON, PATIENTS ON PC DEVICES WERE SIGNIFICANTLY YOUNGER (0.81 VS 15.2 YEARS), SMALLER (0.39 VS 1.46 M2), AND SICKER (INTERMACS PROFILE1 AND 2, ECMO AT IMPLANT AND VENTILATOR SUPPORT; ALL P VALUES <0.05) THAN PATIENTS ON IC. THERE WAS NO DIFFERENCE IN GENDER, DIAGNOSIS, AND DIALYSIS FREQUENCY BETWEEN DEVICES. PC DEVICES HAD A SIGNIFICANTLY HIGHER IAE RATE AND HAD SIGNIFICANTLY MORE SEPSIS IAE. DEVICE RELATED IAE WERE SIGNIFICANTLY HIGHER IN HM3 THAN HVAD [17 (47.2%) VS 7 (17.9%), WHICH SEEM TO BE DRIVEN BY DRIVELINE INFECTIONS.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REFERENCE NUMBER: 2916596-2022-11521.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1141333 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| O