BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 20035718 · Received August 22, 2024

    Report

    Report Number
    2916596-2024-05475
    Event Type
    Injury
    Date Received
    August 22, 2024
    Date of Event
    August 4, 2024
    Report Date
    October 25, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H6: HEALTH EFFECT - CLINICAL CODE CORRECTED. MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER: (B)(6), AND THE REPORT OF ANEMIA COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION REGARDING THIS EVENT WERE SUBMITTED TO THE ACCOUNT; HOWEVER, NO RESPONSE HAS BEEN RECEIVED AT THIS TIME. THE PATIENT REMAINS ONGOING ON (B)(6) WITH NO FURTHER REPORTED ISSUES 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 HEARTMATE (HM) 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION,¿ LISTS ADVERSE EVENTS, INCLUDING RENAL DYSFUNCTION THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS. SECTION 6 OF THE IFU, ¿PATIENT CARE AND MANAGEMENT,¿ PROVIDES INFORMATION REGARDING THE RECOMMENDED ANTICOAGULATION THERAPY AND INR (INTERNATIONAL NORMALIZED RATIO) RANGE. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT WAS SEEN IN CLINIC AND WAS DOING WELL BUT REPORTED LOWER PULSATILITY INDEX (PI) READINGS ON HIS SYSTEM CONTROLLER. ON INTERROGATION, SEVERAL PI EVENTS WERE SEEN FROM (B)(6) 2024 AND (B)(6) 2024. LOG FILE ANALYSIS CONFIRMED CLUSTERS OF PERSISTENT PI EVENTS. NO ALARMS WERE NOTED ON INTERROGATION AND NO ALARMS WERE SEEN IN THE LOG FILES. IT WAS NOTED THAT THE PATIENT HAD ACUTE ANEMIA WITH HEMOGLOBIN OF 7.8 GRAMS PER DECILITER (G/DL) LAST WEEK DESPITE IRON SUPPLEMENT, DOWN FROM 10.9 G/DL PREVIOUSLY, AND REMAINED REDUCED AT 8.1 G/DL. THE PATIENT REPORTED NO MELENA, HEMATOCHEZIA, SYNCOPE, OR LOW FLOW ALARMS. THE PATIENT ALSO DENIED BLEEDING, DARK URINE, PARESTHESIAS OR NEUROLOGIC CHANGES. IT WAS ALSO NOTED THAT THE PATIENT HAD A HISTORY OF CHRONIC KIDNEY DISEASE, STAGE III.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17889 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 7341853 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Other