BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 16762193 · Received April 18, 2023

    Report

    Report Number
    2916596-2023-02318
    Event Type
    Injury
    Date Received
    April 18, 2023
    Date of Event
    March 9, 2023
    Report Date
    April 28, 2023
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE PUMP REMAINS IN USE SUPPORTING THE PATIENT. A CORRELATION BETWEEN THE DEVICE AND THE REPORT OF GASTROINTESTINAL (GI) BLEEDING COULD NOT BE CONCLUSIVELY DETERMINED. BLEEDING IS LISTED IN THE INSTRUCTIONS FOR USE AS A POTENTIAL ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. GI BLEEDING HAS BEEN PREVIOUSLY INVESTIGATED AND WILL CONTINUE TO BE MONITORED THROUGH QUALITY DATA REVIEWS, WHICH ARE CONDUCTED ON PRODUCTION AND POST PRODUCT SIGNALS TO EVALUATE IF PRODUCTS ARE CONFORMING TO PRODUCT REQUIREMENTS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT EXPERIENCED BLEEDING. ON (B)(6) 2023, TESTING WAS PERFORMED AND A BLEEDING FOCUS WAS NOT FOUND, BUT FRESH BLOOD WAS CONFIRMED ON THE ASCENDING COLON SIDE. ON (B)(6) 2023, A CAPSULE ENDOSCOPY WAS PERFORMED. HEMATOCHEZIA (HCZ) OCCURRED ON (B)(6) 2023 AND TESTING WAS DONE. CLIPPING WAS PERFORMED AND DIELAFOY'S LESION OF THE TRANSVERSE COLON WAS RULED OUT. THE PATIENT UNDERWENT A BLOOD TRANSFUSION. THE PATIENT WAS DISCHARGED ON (B)(6) 2023 BECAUSE NO HCZ FINDINGS WERE FOUND, EVEN AFTER THE PATIENT RESUME THEIR DIET.

    Description of Event or Problem · 0

    THERE WAS A CHANGE TO THE PATIENT'S ANTICOAGULATION SINCE THE LAST VISIT. ASPIRIN (ACETYLSALICYLIC ACID) AND EDOXABAN DOSAGES WERE CHANGED. LABORATORY VALUES FROM (B)(6) 2023 SHOWED INTERNATIONAL NORMALIZED RATIO WAS 1.32.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1044850 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 8724836 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention| L| H