BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE

    MDR report key: 20279596 · Received September 23, 2024

    Report

    Report Number
    3007042319-2024-04544
    Event Type
    Injury
    Date Received
    September 23, 2024
    Date of Event
    January 1, 2024
    Report Date
    September 23, 2024
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ### THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. MEDTRONIC WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. THIS EVENT OCCURRED OUTSIDE THE US. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. OF NOTE, MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE-TO-ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT SERIAL/LOT NUMBERS. THE BASELINE GENDER/AGE CHARACTERISTICS IS UNKNOWN/58 YEARS OLD. THE MODEL LISTED IN THE REPORT IS A REPRESENTATIVE OF THE MODEL FAMILY, AS THERE IS NO SPECIFIC MODEL LISTED. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. A REQUEST FOR ADDITIONAL INFORMATION WAS MADE. IF ADDITIONAL INFORMATION IS OBTAINED REGARDING THIS EVENT, IT WILL BE ADDED, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: DRIVELINE INFECTION IN PATIENTS WITH LEFT VENTRICULAR ASSIST DEVICES IMPLANTED AS DESTINATION THERAPY. TRANSPLANTATION PROCEEDINGS. 2024. 56, 860-863. DOI: 10.1016/J.TRANSPROCEED.2024.03.029 D4: UDI INFORMATION IS UNABLE TO BE OBTAINED AS THE PRODUCT WAS DISTRIBUTED OUTSIDE OF THE UNITED STATES AND D4 UDI IS THEREFORE BLANK. ### MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING DRIVELINE INFECTIONS IN PATIENTS WITH A LEFT VENTRICULAR ASSIST DEVICE (VAD). IN ALL PATIENTS DIAGNOSED WITH A DRIVELINE INFECTION, THEY WERE IMMEDIATELY ADMITTED TO THE HOSPITAL AND TREATED WITH TARGETED ANTIBIOTICS AND ADVANCED WOUND CLEANING. THE MOST COMMON PATHOGEN REVEALED IN WOUND SWAB CULTURE WAS METHICILLIN-SENSITIVE STAPHYLOCOCCUS AUREUS AND PSEUDOMONAS AERUGINOSA. THE OTHERS WERE S. EPIDERMIDIS, PROTEUS MIRABILIS, AND CORYNEBACTERIUM AMYCOLATUM. A FEW CASES REQUIRED EXTENSIVE WOUND DEBRIDEMENT. THE AUTHORS DESCRIBED PATIENT DEATHS; THE CAUSES OF DEATH WERE SEPSIS AFTER DIAGNOSIS OF A BLOODSTREAM INFECTION (BSI), MULTIORGAN DYSFUNCTION SYNDROME ALSO CONNECTED WITH INFECTION, CEREBROVASCULAR EVENTS, RIGHT HEART FAILURE, AND TWO PATIENTS DIED DUE TO FAILURE TO RESTART A CONTROLLER. THE STATUS OF THE DEVICES IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1487792 HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Unknown Hospitalization| L| R