BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 25019218 · Received April 28, 2026

    Report

    Report Number
    2916596-2026-02467
    Event Type
    Injury
    Date Received
    April 28, 2026
    Date of Event
    January 1, 2015
    Report Date
    April 28, 2026
    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. DETAILS ARE LISTED IN THE ATTACHED ARTICLE. DEVICE WAS IMPLANTED AT TIME OF EVENT. DATE OF EVENT HAS BEEN ENTERED AS 01JAN2015, AS THE DATE OF DATA COLLECTION WAS BETWEEN 2015 AND 2023. TASOUDIS, P., MCCARTHY, S., MU, J., CHRIS, A. B., RAMACHANDRAN, B., TESSA, A. M., & MERLO, A. (2025). RISK FACTORS FOR LVAD-ASSOCIATED INFECTIONS IN A COHORT OF 221 PATIENTS. THE JOURNAL OF HEART AND LUNG TRANSPLANTATION, 44(4). HTTPS://DOI.ORG/10.1016/J.HEALUN.2025.02.643 TASOUDIS, P., UNIVERSITY OF NORTH CAROLINA, CHAPEL HILL. MANUFACTURER'S INVESTIGATION CONCLUSION: A SPECIFIC CAUSE FOR THE REPORTED INFECTIONS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION, AND A DIRECT CORRELATION WITH HEARTMATE 3 (HM3) LEFT VENTRICULAR ASSIST SYSTEM (LVAS) COULD NOT BE CONCLUSIVELY ESTABLISHED. NO DEVICES WERE RETURNED FOR EVALUATION. DEVICE SERIAL NUMBERS WERE NOT PROVIDED. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), IS CURRENTLY AVAILABLE. SECTION 1 ¿INTRODUCTION¿ OF THIS DOCUMENT LISTS DRIVELINE INFECTION, PUMP POCKET/PSEUDO POCKET INFECTION, AND LOCALIZED INFECTION 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 THE 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 AS WELL AS INFORMATION FOR CARING FOR THE DRIVELINE EXIT SITE. THE CURRENT REVISIONS OF THE IFU AND PATIENT HANDBOOK CAN ALSO BE FOUND ON THE ELECTRONIC IFU (EIFU) PAGE OF THE ABBOTT WEBSITE. 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 TITLED ¿RISK FACTORS FOR LVAD-ASSOCIATED INFECTIONS IN A COHORT OF 221 PATIENTS¿ THAT HEARTMATE 3 (HM3) MAY BE RELATED TO INFECTION. THIS RETROSPECTIVE COHORT STUDY EVALUATED RISK FACTORS FOR LEFT VENTRICULAR ASSIST DEVICE (LVAD)¿ASSOCIATED INFECTIONS AMONG 221 PATIENTS WHO UNDERWENT HM3 IMPLANTATION BETWEEN 2015 AND 2023. OVER A MEDIAN FOLLOW-UP OF 803 DAYS, 55% OF PATIENTS DEVELOPED AN LVAD-ASSOCIATED INFECTION, INCLUDING DRIVELINE, PUMP-POCKET INFECTIONS, OR BACTEREMIA. FACTORS SIGNIFICANTLY ASSOCIATED WITH INFECTION INCLUDED A HIGHER NUMBER OF CENTRAL LINES PLACED DURING THE IMPLANT HOSPITALIZATION, HIGHER BODY MASS INDEX, AND YOUNGER AGE, WHILE LENGTH OF STAY AND POSTOPERATIVE COMPLICATIONS WERE NOT ASSOCIATED WITH INCREASED RISK. OLDER AGE APPEARED TO BE PROTECTIVE AGAINST INFECTION, THOUGH THE UNDERLYING REASONS REMAIN UNCLEAR. THE FINDINGS HIGHLIGHT POTENTIALLY MODIFIABLE RISK FACTORS¿PARTICULARLY CENTRAL LINE USE AND OBESITY¿THAT MAY INFORM STRATEGIES TO REDUCE INFECTION RATES AND IMPROVE OUTCOMES FOLLOWING LVAD IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1073548 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT Ventricular (assist) bypass DSQ THORATEC CORPORATION 106524US 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other