BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 21148918 · Received January 14, 2025

    Report

    Report Number
    2916596-2025-00252
    Event Type
    Malfunction
    Date Received
    January 14, 2025
    Date of Event
    September 1, 2022
    Report Date
    January 14, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS A AND D4: SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN ARTICLE. DEVICE WAS IMPLANTED AT TIME OF EVENT. TUNUGUNTLA, H., CHO, J., CHOUDHRY, S., SPINNER, J., PURI, K., HOPE, K., WATANABE, K., DREYER, W., PRICE, J., BRODA, C., WILSON, D., ELIAS, B., & ADACHI, I. (2024). LONG TERM USE OF IMPLANTABLE LEFT VENTRICULAR ASSIST DEVICES IN PEDIATRIC PATIENTS. THE JOURNAL OF HEART AND LUNG TRANSPLANTATION, 43(4), S173. HTTPS://DOI.ORG/10.1016/J.HEALUN.2024.02.350. TEXAS CHILDREN'S HOSPITAL, HOUSTON,TX; BAYLOR COLLEGE OF MEDICINE, HOUSTON,TX; MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTS OF HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) MALFUNCTION COULD NOT BE CONFIRMED BASED ON THE PROVIDED INFORMATION. A SPECIFIC CAUSE FOR THESE EVENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE SERIAL NUMBERS OR OTHER IDENTIFYING INFORMATION OF THE PRODUCTS WERE NOT REPORTED AND WERE NOT ABLE TO BE DETERMINED DURING THE INVESTIGATION. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) AND THE HEARTMATE 3 PATIENT HANDBOOK ARE CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS DEVICE MALFUNCTIONS AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS. SECTION 8 OF THE PATIENT HANDBOOK, ¿HANDLING EMERGENCIES¿, LISTS EXAMPLES OF EMERGENCIES AND THE RECOMMENDED ACTIONS ASSOCIATED WITH THESE EMERGENCIES. FURTHERMORE, THE PATIENT HANDBOOK INSTRUCTS THE USER TO CALL THEIR HOSPITAL CONTACTS IF THEY THINK, FOR ANY REASON, ANY PORTION OF THEIR EQUIPMENT IS NOT FUNCTIONING AS USUAL, IS BROKEN, OR THEY ARE UNCOMFORTABLE WITH THE OPERATION OF THE EQUIPMENT. 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 "LONG TERM USE OF IMPLANTABLE LEFT VENTRICULAR ASSIST DEVICES IN PEDIATRIC PATIENTS" THAT THE HM3 MAY BE RELATED TO DEVICE MALFUNCTION REQUIRING PUMP EXCHANGE(N=3). A STUDY FROM MAY2008 -SEPT2022 WAS PERFORMED ON PATIENTS THAT WERE <19 YEARS OF AGE LIVING WITH AN LVAD FOR MORE THAN 1 YEAR. THE SUMMARY STATISTICS WERE USED TO DESCRIBE PATIENT DEMOGRAPHICS, LENGTH OF SUPPORT, FREQUENCY OF NON-ELECTIVE READMISSIONS, ADVERSE EVENTS (PER PEDIMACS CRITERIA), AND OUTCOMES. 90 PATIENTS RECEIVED 91 CONTINUOUS FLOW VENTRICULAR ASSIST DEVICE (CFVAD) DURING THE STUDY, OF THESE 29 PATIENTS HAD VAD FOR MORE THAN 1 YEAR. 20 PATIENTS FOR 1-3 YEARS, 5 PATIENTS FOR 3-5 YEARS, 4 PATIENTS FOR >5 YEARS, AND THE LONGEST SUPPORTED PATIENTS FOR 12 YEARS. VAD SUPPORT WAS ON HM2(N=1), HVAD (N=23), AND HM3 (N=5). THERE WERE 81 READMISSIONS OVER 29,812 VAD SUPPORT DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1426523 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT Ventricular (assist) bypass DSQ THORATEC CORPORATION 106524US

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown