BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 13804590 · Received March 18, 2022

    Report

    Report Number
    2916596-2022-01189
    Event Type
    Injury
    Date Received
    March 18, 2022
    Date of Event
    February 21, 2022
    Report Date
    March 25, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE REPORTED EVENTS AND THE DEVICE COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. THE SUBMITTED LOG FILES CAPTURED NO NOTABLE EVENTS. THE PUMP APPEARED TO HAVE OPERATED AS INTENDED AT THE SET SPEED. THE PATIENT REMAINS ONGOING ON HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6). NO FURTHER RELATED EVENTS HAVE BEEN REPORTED AT THIS TIME. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR MLP-023894 WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LVAS INSTRUCTIONS FOR USE (IFU), REV. C, IS CURRENTLY AVAILABLE. SECTION 1, "INTRODUCTION," LISTS BLEEDING AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LVAS. SECTION 6, ¿PATIENT CARE AND MANAGEMENT¿ (UNDER ¿ANTICOAGULATION¿), PROVIDES THE RECOMMENDED ANTICOAGULATION REGIMEN, INCLUDING INTERNATIONAL NORMALIZED RATIO (INR) RANGE, AS WELL AS SUGGESTED ANTICOAGULATION MODIFICATIONS. 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 WAS EXPERIENCING FREQUENT PULSATILITY INDEX (PI) EVENTS DUE TO A UPPER GASTROINTESTINAL BLEED (GIB). LOG FILES CONFIRMED PI EVENTS BETWEEN (B)(6) 2022 AND (B)(6) 2022. THE PATIENT HAD ANEMIA AND RECEIVED BLOOD PRODUCTS. ON (B)(6) 2022 THE PATIENT HAD SUDDEN ONSET OF LEFT EYE MONOCULAR VISION LOSS THAT LASTED APPROXIMATELY 2 MINUTES. THE PATIENT'S GIB RESOLVED ON (B)(6) 2022. CONTROLLER MFR # 2916596-2022-01351.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47041 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524US 7719892 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Required Intervention| H