BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

    MDR report key: 21877222 · Received April 21, 2025

    Report

    Report Number
    3007042319-2025-00805
    Event Type
    Death
    Date Received
    April 21, 2025
    Date of Event
    November 1, 2024
    Report Date
    April 21, 2025
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 MALE/64 YEARS OLD. THE MODEL LISTED IN THE REPORT IS A REPRESENTATIVE OF THE MODEL FAMILY, AS THERE IS NO SPECIFIC MODEL LISTED. THE DATE OF DEATH IS NOT AVAILABLE AT THE TIME OF THIS REPORT AS THERE IS NO INDICATION OF SPECIFIC SERIAL NUMBER/PATIENT INFORMATION. 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: SAFETY OF CHEST COMPRESSIONS IN PATIENTS WITH A DURABLE LEFT VENTRICULAR ASSIST DEVICE. JACC: HEART FAILURE. 2024. VOL. 12, NO. 11. 1928-1930. DOI: 10.1016/J.JCHF.2024.03.004 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 THE SAFETY OF CHEST COMPRESSIONS AS PART OF CARDIOPULMONARY RESUSCITATION (CPR) FOR PATIENTS WITH LEFT VENTRICULAR ASSIST DEVICES (VADS). PATIENTS IN THE STUDY WERE DIVIDED BETWEEN THOSE THAT UNDERWENT COMPRESSION AND THOSE THAT DID NOT. THE AUTHORS DESCRIBED THAT PATIENTS WERE ADMITTED TO THE HOSPITAL DUE TO DIAGNOSES OF INFECTION, BLEEDING, UNKNOWN VAD DYSFUNCTION, OUT-OF-HOSPITAL ARREST, AND OTHER UNKNOWN REASONS. PATIENTS EXPERIENCED CARDIAC ARREST DUE TO ARRHYTHMIAS, VENTRICULAR TACHYCARDIA (VT)/VENTRICULAR FIBRILLATION (VF), ASYSTOLE, PULSELESS ELECTRICAL ACTIVITY, ALTERED MENTAL STATUS, UNKNOWN VAD ALARMS/DYSFUNCTIONS, AND OTHER UNKNOWN REASONS. PATIENTS WITH AND WITHOUT COMPRESSION SUFFERED INTERMEDIATE TO SIGNIFICANT NEUROLOGIC DEFICITS. THERE WERE PATIENT DEATHS IN BOTH COMPRESSION AND NON-COMPRESSION GROUPS; HOWEVER, THE SPECIFIC CAUSES OF DEATH WERE UNKNOWN. 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
    1016276 HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Death