BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 17167486 · Received June 20, 2023

    Report

    Report Number
    2916596-2023-03516
    Event Type
    Injury
    Date Received
    June 20, 2023
    Date of Event
    May 17, 2023
    Report Date
    August 3, 2023
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    117

    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 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6), AND THE REPORTED EVENTS COULD NOT CONCLUSIVELY BE ESTABLISHED THROUGH THIS EVALUATION. THE PATIENT REMAINS ONGOING ON THE HM 3 LVAS, SERIAL NUMBER (B)(6), WITH NO FURTHER ISSUES REPORTED AT THIS TIME. NO PRODUCT IS AVAILABLE FOR INVESTIGATION. 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 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. SECTION 1, ¿INTRODUCTION¿ LISTS BLEEDING AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS. SECTION 6, ¿PATIENT CARE AND MANAGEMENT,¿ PROVIDES THE RECOMMENDED ANTICOAGULATION REGIMEN, INCLUDING INTERNATIONAL NORMALIZED RATIO (INR) RANGE, AS WELL AS SUGGESTED ANTICOAGULATION MODIFICATIONS IN THE EVENT THAT THERE IS A RISK OF BLEEDING. 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 WAD ADMITTED ON (B)(6) 2023 FOR ANEMIA AND CONGESTIVE HEART FAILURE (CFH) EXACERBATION. HYPOTHYROIDISM WAS DIAGNOSED WITH THE LABWORK PERFORMED UPON ADMISSION. THE PATIENT ALSO HAD POSSIBLE DEPRESSION. A G-SCOPE SHOWED NO SIGNS OF BLEEDING, BARRETT'S ESOPHAGUS, AND A POLYP IN THE STOMACH. A POLYPECTOMY WAS PERFORMED. NO SOURCE OF BLEEDING WAS IDENTIFIED. A COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) WAS PLANNED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462554 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 8396163 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention| H