BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)

    MDR report key: 10092364 · Received May 27, 2020

    Report

    Report Number
    2916596-2020-02716
    Event Type
    Injury
    Date Received
    May 27, 2020
    Date of Event
    May 19, 2020
    Report Date
    June 27, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011224
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A SPECIFIC CAUSE FOR THE REPORT OF ELEVATED LDH COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION, AND A DIRECT CORRELATION WITH HEARTMATE II LVAS, SERIAL NUMBER (B)(6), COULD NOT BE CONCLUSIVELY ESTABLISHED. ADDITIONALLY, A DIRECT CORRELATION BETWEEN HEARTMATE II LVAS, SERIAL NUMBER (B)(6), AND THE REPORT OF WORSENING HEART FAILURE SYMPTOMS, INCLUDING WEIGHT GAIN AND ELEVATED JUGULAR VENOUS PRESSURE (JVP) COULD NOT CONCLUSIVELY BE ESTABLISHED THROUGH THIS EVALUATION. THE PATIENT REMAINS ONGOING ON (B)(6) AT HOME WITHOUT ISSUES AS OF (B)(6) 2020. A REVIEW OF THE SUBMITTED LOG FILE FROM (B)(6) 2020 FOUND THAT THE PUMP MAINTAINED A SPEED ABOVE THE LOW SPEED LIMIT. THE SYSTEM APPEARED TO BE OPERATING AS INTENDED AND THERE WERE NO NOTABLE ALARMS ACTIVE IN THE LOG FILE. THE PATIENT REMAINS ONGOING ON (B)(6) WITH NO ADDITIONAL COMPLAINTS AT THIS TIME. THE HEARTMATE II LVAS IFU LISTS HEMOLYSIS AS A POTENTIAL RISK/ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE II LVAS. THIS DOCUMENT ALSO STATES THAT POST-IMPLANTATION HYPERTENSION MAY BE TREATED AT THE DISCRETION OF THE ATTENDING PHYSICIAN. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A SLOWLY ELEVATING LDH (LACTATE DEHYDROGENASE) LEVEL AS WELL AS WORSENING HEART FAILURE SYMPTOMS THAT INCLUDED WEIGHT GAIN, ELEVATED JVP (JUGULAR VENOUS PRESSURE). THERE WERE NO SYMPTOMS OR SIGNS OF THROMBOSIS. A LOG FILE WAS SENT IN FOR ANALYSIS AND THERE WERE NO UNUSUAL EVENTS. PLAN OF CARE WAS TO REPEAT LDH TEST AND AN ECHO IF THE LDH REMAINED ELEVATED, THE PATIENT WAS SENT HOME WITH NO FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555649 HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS) VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106015 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR