BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 25164737 · Received May 13, 2026

    Report

    Report Number
    2916596-2026-2916642
    Event Type
    Injury
    Date Received
    May 13, 2026
    Date of Event
    January 1, 2024
    Report Date
    May 13, 2026
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS A AND D: SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. DEVICE WAS IMPLANTED AT TIME OF EVENT. SECTION B3: DATE OF EVENT HAS BEEN ENTERED AS 01JAN2024 AS THE PATIENTS WERE IMPLANTED BETWEEN 2015 AND 2024. AUTHOR INFORMATION: RAMACHANDRAN, B. C., JIN, M., AGALA, C. B., TASOUDIS, P., MCCARTHY, S., MERLO, A., & ANDERMANN, T. M. (2025). RECURRENCE RISK OF LVAD-SPECIFIC INFECTIONS IN PATIENTS WITH SURGICAL VERSUS NON-SURGICAL MANAGEMENT. THE JOURNAL OF HEART AND LUNG TRANSPLANTATION, 44(4). HTTPS://DOI.ORG/10.1016/J.HEALUN.2025.02.674. RAMACHANDRAN, B. C., UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL, CHAPEL HILL, NC 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) REV. D, IS CURRENTLY AVAILABLE. SECTION 1 ¿INTRODUCTION¿ OF THIS DOCUMENT LISTS DRIVELINE INFECTION, LOCALIZED INFECTION, AND PUMP POCKET/PSEUDO POCKET 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 REV. A, 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 ¿RECURRENCE RISK OF LVAD-SPECIFIC INFECTIONS IN PATIENTS WITH SURGICAL VERSUS NON-SURGICAL MANAGEMENT¿ THAT HEARTMATE3 (HM3) MAY BE RELATED TO INFECTION. THIS RETROSPECTIVE SINGLE-CENTER STUDY EVALUATED WHETHER MEDICAL MANAGEMENT ALONE REDUCES RECURRENCE OF LEFT VENTRICULAR ASSIST DEVICE (LVAD) DRIVELINE INFECTIONS (DLI) COMPARED WITH SURGICAL MANAGEMENT AMONG HEARTMATE 3 RECIPIENTS IMPLANTED BETWEEN 2015 AND 2024. AMONG 221 LVAD PATIENTS, 81 DEVELOPED AT LEAST ONE LVAD-SPECIFIC INFECTION WITH AT LEAST ONE YEAR OF FOLLOW-UP, ACCOUNTING FOR 126 INFECTIOUS EPISODES. RECURRENCE OF INFECTION WITH THE SAME ORGANISM WITHIN ONE YEAR WAS HIGHER IN NON-SURGICALLY MANAGED INFECTIONS, DESPITE SIMILAR CURE RATES BETWEEN MEDICAL AND SURGICAL COHORTS, AND NON-SURGICAL PATIENTS EXPERIENCED SHORTER ANTIBIOTIC-FREE INTERVALS BUT FEWER NEW INFECTIONS WITH DIFFERENT ORGANISMS. REGARDLESS OF MANAGEMENT STRATEGY, MOST INFECTIONS BECAME CHRONIC AND REQUIRED LONG-TERM SUPPRESSIVE ANTIBIOTIC THERAPY. IN THIS SINGLE-CENTER STUDY OF LVAD RECIPIENTS, RECURRENCE WAS HIGHER IN NON-SURGICALLY TREATED PATIENTS FOR BOTH THE FIRST NEW INFECTION AND FOR ALL INFECTIOUS INSTANCES. OTHER OUTCOMES (CURE, CHRONIC, OR NEW INFECTIONS) WERE VARIABLE, WITH LITTLE STATISTICAL POWER TO DETERMINE SIGNIFICANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225866 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT Ventricular (assist) bypass DSQ THORATEC CORPORATION 106524US 813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| L