BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 16016325 · Received December 20, 2022

    Report

    Report Number
    2916596-2022-15751
    Event Type
    Injury
    Date Received
    December 20, 2022
    Date of Event
    December 11, 2022
    Report Date
    January 23, 2023
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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

    MANUFACTURE¿S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE DEVICE AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. THE PATIENT REMAINS ONGOING ON HEARTMATE (HM) 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6). NO FURTHER EVENTS HAVE BEEN REPORTED AT THIS TIME. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. SECTION 1, "INTRODUCTION," LISTS BLEEDING AS AN ADVERSE EVENT WHICH 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. THE CURRENT HEARTMATE 3 LVAS PATIENT HANDBOOK IS CURRENTLY AVAILABLE. SECTION 1. "INTRODUCTION," CAUTIONS, "CALL YOUR HOSPITAL CONTACT RIGHT AWAY IF YOU NOTICE A CHANGE IN HOW YOUR PUMP SOUNDS, FEELS, OR WORKS. EVEN SMALL CHANGES SHOULD BE REPORTED." THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR MLP-031459 WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. 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 HAD GASTROINTESTINAL BLEEDING WITH A HEMOGLOBIN DROP OF 3 TO <5 G/DL, CHEST PAIN AND BLACK TARRY STOOLS. AN X-RAY AND LAB ASSESSMENTS WERE PERFORMED, AND THE PATIENT WAS GIVEN VITAMIN K AND PACKED RED BLOOD CELLS (PRBCS). THE BLEEDING WAS NOT CONSIDERED TO BE DEVICE RELATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD GASTROINTESTINAL BLEEDING WITH A HEMOGLOBIN DROP OF 3 TO <5 G/DL, CHEST PAIN AND BLACK TARRY STOOLS. AN X-RAY AND LAB ASSESSMENTS WERE PERFORMED AND THE PATIENT WAS GIVEN VITAMIN K AND PACKED RED BLOOD CELLS (PRBCS). THE BLEEDING WAS NOT CONSIDERED TO BE DEVICE RELATED. THE BLEEDING WAS RESOLVED AND THE PATIENT WAS DISCHARGED IN STABLE CONDITON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2553423 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 8385793 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention| H