BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 9251512 · Received October 29, 2019

    Report

    Report Number
    2916596-2019-04964
    Event Type
    Injury
    Date Received
    October 29, 2019
    Date of Event
    June 3, 2019
    Report Date
    December 4, 2019
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A SPECIFIC CAUSE FOR THE PATIENT'S INFECTION COULD NOT CONCLUSIVELY BE DETERMINED THROUGH THIS EVALUATION. ADDITIONALLY, A DIRECT CORRELATION BETWEEN HEARTMATE 3 LVAS, SERIAL NUMBER (B)(4), AND THE PATIENT¿S GI BLEED COULD NOT CONCLUSIVELY BE ESTABLISHED THROUGH THIS EVALUATION. THE PATIENT REMAINS ONGOING ON HEARTMATE 3 LVAS, SERIAL NUMBER (B)(4) WITH NO FURTHER REPORTED ISSUES. THE HEARTMATE 3 LVAS IFU LISTS INFECTION (LOCALIZED, DRIVELINE, AND PUMP POCKET OR PSEUDO POCKET INFECTION) AND BLEEDING AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. THIS DOCUMENT PROVIDES INFORMATION REGARDING ANTICOAGULATION, INCLUDING RECOMMENDED INR VALUES AND THE SUGGESTED ANTICOAGULATION MODIFICATIONS IN THE EVENT THAT THERE IS A RISK OF BLEEDING. THE IFU, AS WELL AS THE HEARTMATE 3 LVAS PATIENT HANDBOOK, ALSO PROVIDE INFORMATION REGARDING HOW TO PREVENT INFECTION. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC REPORTING CHILLS AND DIARRHEA. THE PATIENT WAS ADMITTED ON (B)(6) 2019, TESTED POSITIVE FOR CLOSTRIDIUM DIFFICILE(C. DIFF), AND WAS TREATED WITH VANCOMYCIN. ON (B)(6) 2019 BRIGHT RED BLOOD WAS OBSERVED IN DIARRHEA AND THE PATIENT'S INTERNATIONAL NORMALIZED RATIO WAS SUPRATHERAPEUTIC. THE PATIENT WAS TRANSFUSED 7 UNITS PACKED RED BLOOD CELLS. A ESOPHAGOGASTRODUODENOSCOPY WAS PERFORMED ON (B)(6) 2019 AND PATIENT WAS NEGATIVE FOR ACTIVE BLEEDING. PATIENT WAS DISCHARGED AFTER C. DIFF TREATMENT IN STABLE CONDITION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1043671 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524US 6857030 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| L