BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 25088188 · Received May 5, 2026

    Report

    Report Number
    2916596-2026-2916665
    Event Type
    Injury
    Date Received
    May 5, 2026
    Date of Event
    April 1, 2025
    Report Date
    May 5, 2026
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 THE DATE OF PUBLICATION SINCE THE DATE OF DATA COLLECTION WAS NOT PROVIDED. AUTHOR INFORMATION: KORE, S., CALLAN, P., SHAW, S., HOOPER, J., GIULIANO, K. K., & VENKATESWARAN, R. (2025). SILVERLON: MINIMIZING PATIENT AND HEALTHCARE PROVIDER BURDEN. THE JOURNAL OF HEART AND LUNG TRANSPLANTATION, 44(4). HTTPS://DOI.ORG/10.1016/J.HEALUN.2025.02.676. WYTHENSHAWE HOSPITAL MANCHESTER, UNITED KINGDOM. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH THE RESEARCH ABSTRACT TITLED ¿SILVERLON: MINIMIZING PATIENT AND HEALTHCARE PROVIDER BURDEN¿ IDENTIFYING THAT HEARTMATE 3 (HM3) MAY BE RELATED TO DRIVELINE INFECTION (DLI). THIS IS STUDY LOOKING AT PATIENTS IMPLANTED WITH HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE (LVAD) BETWEEN NOV2015 AND SEP2023 AND ALIVE ON DEVICE SUPPORT BETWEEN (B)(6) 2023 WERE INCLUDED IN THE STUDY AND FOLLOWED UP UNTIL TRANSPLANT, PUMP DECOMMISSIONING, OR DEATH. PATIENTS WITH EXISTING DLI (DESTINE STAGING > 2A) AND NON-CONSENTING PATIENTS WERE EXCLUDED FROM THE STUDY. A SINGLE CHANGE TO DRIVELINE DRESSING PROTOCOL WAS MADE BY SUBSTITUTING SILVERLON FOR OTHER PRIMARY DRESSINGS OVER DRIVELINE EXIT SITE (DLES). SILVERLON IS A SILVER IMPREGNATED DRESSING WHICH CONTAINS MORE THAN FIVE TIMES THE AMOUNT OF PURE METALLIC SILVER THAN OTHER SILVER-BASED DRESSINGS. THE IMPACT OF SILVERLON IN PREVENTING DLI AND READMISSIONS WAS ASSESSED, AND THE INCIDENCE OF DLI AND NUMBER OF READMISSIONS WERE EVALUATED. 73 PATIENTS WERE ALIVE ON DEVICE BETWEEN (B)(6) 2023; 4 HAD PREEXISTING DLI. SILVERLON WAS USED IN 57 PATIENTS (84% MALE, 51% ISCHEMIC, MEAN INTERMACS 2.9, 44% BLOOD GROUP O, 49% BRIDGE TO CANDIDACY) FOR AN AVERAGE PERIOD OF 30 WEEKS (2-36 WEEKS). THERE WERE NO INCIDENCES OF DLI IN PATIENTS USING SILVERLON AND NO DLI RELATED READMISSIONS. FOR PATIENTS IN WHOM OTHER DRESSINGS WERE USED, THERE WERE 5 INCIDENCES OF DLI AND 5 EPISODES OF READMISSIONS. FOLLOWING CESSATION OF SILVERLON USE (DUE TO NONAVAILABILITY IN THE U.K.); OUT OF 57 PATIENTS IN WHOM SILVERLON WAS USED, 50 WERE ALIVE ON DEVICE, 3 PATIENTS DEVELOPED DLI, 4 WERE TRANSPLANTED AND 3 DIED (OTHER CAUSES). THE STUDY CONCLUDED THAT SILVERLON USE TO BE EFFECTIVE IN PREVENTION OF DLI AND DLI RELATED READMISSIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218613 HEARTMATE 3 LVAS IMPLANT KIT Ventricular (assist) bypass DSQ THORATEC CORPORATION 106524INT

    Patients

    Seq Age Sex Outcome Treatment
    1