BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE

    MDR report key: 21860015 · Received April 17, 2025

    Report

    Report Number
    3007042319-2025-00784
    Event Type
    Injury
    Date Received
    April 17, 2025
    Date of Event
    July 12, 2023
    Report Date
    April 17, 2025
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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 UNKNOWN. 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. REFERENCED ARTICLE: COMING SOON TO AN OR NEAR YOU: A CHILD WITH A VENTRICULAR ASSIST DEVICE. CURRENT ANESTHESIOLOGY REPORTS. 2023. 1 3:172¿180. DOI: 10.1007/S40140-023-00565-1 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 A REVIEW OF PEDIATRIC PATIENTS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (VAD). THE AUTHORS DESCRIBED PATIENT DEATHS; HOWEVER, THE SPECIFIC CAUSES OF DEATH WERE UNKNOWN. THEY DESCRIBE ADVERSE EVENTS IN THESE PATIENTS WHICH INCLUDED RIGHT VENTRICULAR (RV) FAILURE, BLEEDING EVENTS, WHICH INCLUDED GASTROINTESTINAL BLEED (GIB). INFECTIONS WHICH INCLUDE DRIVELINE INFECTIONS, STROKES, RESPIRATORY FAILURE, CEREBRAL HEMORRHAGE, AND PUMP THROMBOSIS. SIGNS OF RV FAILURE INCLUDED DECREASED VAD FLOW, SUCTION EVENTS, HEPATIC CONGESTION, ACUTE KIDNEY INJURY, AND DECREASED CARDIAC OUTPUT. INTERVENTIONS PERFORMED FOR THE VARIOUS ADVERSE EVENTS INCLUDE SURGICAL, MEDICAL MANAGEMENT, AND THE IMPLANT OF A RIGHT VAD. DEVICES EXHIBITED MALFUNCTIONS OF UNKNOWN ORIGIN. THE STATUS OF THE VADS IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30907 HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| R| H