BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 11604080 · Received April 1, 2021

    Report

    Report Number
    2916596-2021-01357
    Event Type
    Injury
    Date Received
    April 1, 2021
    Date of Event
    March 1, 2021
    Report Date
    May 27, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    ONSET OF DRIVELINE INFECTION IS REPORTED AND ADDRESSED UNDER MFR # 2916596-2020-02647. MAIN INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LVAS, SERIAL NUMBER (B)(6), AND THE REPORTED EVENTS COULD NOT CONCLUSIVELY BE ESTABLISHED THROUGH THIS EVALUATION. THE ACCOUNT SUBMITTED LOG FILES FOR REVIEW. THE SYSTEM CONTROLLER EVENT LOG FILE CONTAINS DATA FROM 07MAR2021 AT 10:01:22 THROUGH 10:53:03. TRANSIENT PI EVENTS WERE OBSERVED THROUGHOUT THE LOG FILE, RESULTING IN MOMENTARY DECREASES IN SPEED PER DESIGN. THE PUMP APPEARED TO FUNCTION AS INTENDED. THE PATIENT ULTIMATELY EXPIRED ON 07APR2021 DUE TO ANOXIC BRAIN INJURY (REFERENCE MFR # 2916596-2021-01983). THE HEARTMATE 3 LVAD, SERIAL NUMBER MLP-010653, WAS NOT RETURNED FOR ANALYSIS. THE CURRENT HEARTMATE 3 LVAS IFU LISTS INFECTION AS ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. THIS IFU, AS WELL AS THE HM3 LVAS PATIENT HANDBOOK, ALSO PROVIDE INFORMATION REGARDING HOW TO PREVENT INFECTION. IN ADDITION, THIS DOCUMENT OUTLINES THE RECOMMENDED ANTICOAGULATION REGIMEN AND INR RANGE. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), REV. C, IS CURRENTLY AVAILABLE. SECTION 1 ¿INTRODUCTION¿ OF THIS DOCUMENT LISTS INFECTION AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS. THIS IFU, AS WELL AS THE HM3 LVAS PATIENT HANDBOOK, ALSO PROVIDE INFORMATION REGARDING HOW TO PREVENT INFECTION. IN ADDITION, THIS DOCUMENT OUTLINES THE RECOMMENDED ANTICOAGULATION REGIMEN AND INR RANGE. THE HEARTMATE 3 LVAS PATIENT HANDBOOK, REV. C, IS ALSO AVAILABLE AT THE TIME OF IMPLANT. SEVERAL SECTIONS OF THIS HANDBOOK PROVIDE CARE INSTRUCTIONS IN REGARDS TO PREVENTING INFECTION. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR(B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR THE PERCUTANEOUS LEAD WERE ALSO REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE IMPLANT KIT WAS SHIPPED ON 18JUL2018. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED WITH BACTEREMIA IN THE SETTING OF POOR ADHERENCE WITH OUTPATIENT ANTIBIOTIC REGIMEN FROM A CHRONIC DRIVELINE STAPHYLOCOCCUS EPIDERMIDIS INFECTION (MANUFACTURER REPORT NUMBER 2916596-2020-02647). PATIENT WAS ALSO VOLUME OVERLOADED ON ADMISSION, BUT VOLUME STATUS IMPROVED AFTER AGGRESSIVE DIURESIS (ACTUALLY LIKELY A LITTLE INTRAVASCULARLY DRY AT THIS POINT). HE WAS HAVING VERY FREQUENT PI EVENTS WITH RELATIVELY FREQUENT SPEED DROPS OVER THE PAST 48-72HR. PATIENT WAS GIVEN DALBAVANCIN INFUSION FOR TWO WEEKS. PI EVENTS / SPEED DROPS WERE POSSIBLY RELATED TO HYPOTENSIVE EPISODES AND RESOLVED WITH LVAD OPTIMIZATION AND ANTIHYPERTENSIVES DISCONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500087 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524US 6506515 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R