BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 13357346 · Received January 26, 2022

    Report

    Report Number
    2916596-2022-00090
    Event Type
    Injury
    Date Received
    January 26, 2022
    Date of Event
    November 9, 2021
    Report Date
    April 4, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6), AND THE REPORT OF RIGHT HEART FAILURE WITH SYMPTOMS OF PERIPHERAL EDEMA COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. IT WAS REPORTED THAT THE PATIENT DEVELOPED RIGHT HEART FAILURE ON (B)(6) 2021 WITH SYMPTOMS OF PERIPHERAL EDEMA. IT WAS REPORTED THAT THE PATIENT ORIGINALLY HAD RIGHT HEART FAILURE AND WAS BEING FOLLOWED UP WITH ON AN OUTPATIENT BASIS BY ADJUSTING DIURETIC MEDICATIONS. THE PATIENT¿S RIGHT HEART FAILURE WAS NOT CONSIDERED TO BE DEVICE-RELATED. THE PATIENT REMAINS ONGOING ON (B)(6) WITH NO FURTHER RELATED ISSUES REPORTED AT THIS TIME. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE IMPLANT KIT WAS SHIPPED ON (B)(6) 2020. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), IS CURRENTLY AVAILABLE. SECTION 1 ¿INTRODUCTION¿ OF THIS DOCUMENT LISTS RIGHT HEART FAILURE AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS. ADDITIONALLY, SECTION 6 ¿PATIENT CARE AND MANAGEMENT¿ LISTS RIGHT HEART FAILURE AS A POTENTIAL RISK/ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LVAS. THIS SECTION (UNDER ¿RIGHT HEART FAILURE¿) ALSO OUTLINES INDICATIONS OF RIGHT HEART FAILURE AS WELL AS POSSIBLE TREATMENTS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED RIGHT HEART FAILURE ON (B)(6) 2021. THE PATIENT EXPERIENCED PERIPHERAL EDEMA. IT WAS NOTED THAT THE EVENT WAS NOT DIRECTLY RELATED TO THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT ORIGINALLY HAD RIGHT HEART FAILURE AND WAS FOLLOWED UP ON AN OUTPATIENT BASIS BY ADJUSTING DIURETICS. THE RIGHT HEART FAILURE WAS NOT DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1034965 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524US 7730480 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male Required Intervention| H