BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 12804990 · Received November 12, 2021

    Report

    Report Number
    2916596-2021-06164
    Event Type
    Injury
    Date Received
    November 12, 2021
    Date of Event
    August 1, 2020
    Report Date
    December 7, 2021
    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

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    SECTION H6 HEALTH EFFECT - CLINICAL CODE: "1735 - BACTERIAL INFECTION" CORRECTED TO "4544 - SKIN INFECTION". MANUFACTURER'S INVESTIGATION CONCLUSION: A CORRELATION BETWEEN THE DEVICE AND THE REPORT OF INFECTION COULD NOT BE CONCLUSIVELY DETERMINED. INFECTION IS LISTED IN THE INSTRUCTIONS FOR USE AS A POTENTIAL ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. INFECTION HAS BEEN PREVIOUSLY INVESTIGATED AND WILL CONTINUE TO BE MONITORED THROUGH QUALITY DATA REVIEWS, WHICH ARE CONDUCTED ON PRODUCTION AND POST PRODUCT SIGNALS TO EVALUATE IF PRODUCTS ARE CONFORMING TO PRODUCT REQUIREMENTS. 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 ABSTRACT ¿INCIDENCE OF DRIVELINE INFECTIONS IN HEARTMATE 3 COMPARED TO HEARTMATE 2¿ IDENTIFYING THAT HM3 MAY BE RELATED TO DRIVELINE INFECTION. THIS WAS A SINGLE-CENTER, RETROSPECTIVE COHORT STUDY OF PATIENTS WHO HAVE RECEIVED AN LVAD FROM MAR2011 TO AUG2020. THE DATA WERE OBTAINED BY DEVICE, DEMOGRAPHIC DATA, RISK FACTORS FOR DRIVLINE INFECTION (DLI), TIME UNTIL FIRST DLI, PATHOGENS, AND TREATMENT. A TOTAL OF 17 PATIENTS RECEIVED HM3. 18% DEVELOPED A DLI BY 3 MONTHS POST IMPLANTATION; THE RELATIVE RISK FOR HM3 PATIENTS DEVELOPING DLIS WAS 1.372 (CI .681 - 2.2381, P=.694) COMPARED TO HM2 PATIENTS. THE MEAN TIME TO DLI POST IMPLANTATION WAS 174.8 DAYS. IN OUR PATIENT POPULATION DLI OCCURRED EARLIER AND MORE OFTEN IN THE HM3 GROUP. SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. DEVICE WAS IMPLANTED AT TIME OF EVENT. DATE OF EVENT IS APPROXIMATE AS THE DATA WERE COLLECTED BETWEEN MARCH, 2011 TO AUGUST, 2020. AR MALKOUN, ET AL. ASAIO JOURNAL67.SUPPL 2: 113. LIPPINCOTT WILLIAMS AND WILKINS. (JUN 2021). DOI: HTTP://DX.DOI.ORG/10.1097/MAT.0000000000001492 UNIVERSITY OF CINCINNATI COLLEGE OF MEDICINE, CINCINNATI, OH, USA

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1704046 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524US 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other