BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE

    MDR report key: 21875808 · Received April 21, 2025

    Report

    Report Number
    3007042319-2025-00800
    Event Type
    Injury
    Date Received
    April 21, 2025
    Date of Event
    January 1, 2025
    Report Date
    April 21, 2025
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    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. 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 MALE/47 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: PUMP EXCHANGE FOR MAJOR DEVICE RELATED INFECTION IN PATIENTS RECEIVING A DURABLE LEFT VENTRICULAR ASSIST DEVICE. THE JOURNAL OF HEART AND LUNG TRANSPLANTATION. 2025; 44:686¿689. DOI: 10.1016/J.HEALUN.2024.11.032 D4: UDI INFORMATION IS UNABLE TO BE OBTAINED AS THE NECESSARY INFORMATION IS UNAVAILABLE 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 DEVICE-RELATED INFECTIONS IN LEFT VENTRICULAR ASSIST DEVICE (VAD) PATIENTS. THE AUTHORS STUDIED PATIENTS WHO UNDERWENT PUMP EXCHANGE AFTER DIAGNOSIS OF A DEVICE-RELATED INFECTION, WHICH INCLUDED DRIVELINE INFECTIONS, EXTERNAL SURFACE OF AN IMPLANTABLE COMPONENT, OR INFECTION OF THE BLOOD CONTACTING SURFACES AFTER PRIMARY IMPLANTATION OF A VAD. PATIENTS WERE INITIALLY HOSPITALIZED AND TREATED WITH MEDICATIONS INITIALLY AND RE-ADMITTED AT LEAST THREE TIMES BEFORE UNDERGOING A PUMP EXCHANGE. ORGANISMS FOUND INCLUDED STAPHYLOCOCCUS AUREUS (METHICILLIN-SENSITIVE AND METHICILLIN-RESISTANT), SERRATIA MARCESCENS, PSEUDOMONAS SPECIES, AND PROTEUS MIRABILIS. THERE WERE PATIENT DEATHS WHICH INCLUDED OPERATIVE MORTALITY (DEATH WITHIN 30-DAYS OR IN-HOSPITAL MORTALITY); HOWEVER, THE SPECIFIC CAUSES OF DEATH WERE UNKNOWN. THE STATUS OF THE VADS IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1259878 HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male Hospitalization| R| L