BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

    MDR report key: 25162714 · Received May 13, 2026

    Report

    Report Number
    3007042319-2026-00861
    Event Type
    Death
    Date Received
    May 13, 2026
    Date of Event
    September 26, 2023
    Report Date
    May 13, 2026
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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/59 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. IF ADDITIONAL INFORMATION IS OBTAINED REGARDING THIS EVENT, IT WILL BE ADDED, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: THE SOCIETY OF THORACIC SURGEONS INTERMACS 2023 ANNUAL REPORT: FOCUS ON MAGNETICALLY LEVITATED DEVICES. THE ANNALS OF THORACIC SURGERY. 2024. 117:33-44. DOI: 10.1016/J.ATHORACSUR.2023.11.004. 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 VENTRICULAR ASSIST DEVICES (VADS). THE ARTICLE DISCUSSED THE INTERAGENCY REGISTRY FOR MECHANICALLY ASSISTED CIRCULATORY SUPPORT (INTERMACS) REPORT, COVERING DATA ON IMPLANTATION AND FOLLOW-UP ON CLINICAL OUTCOMES FROM 2013-2022 ON MAGNETICALLY LEVITATED VERSUS NON-MAGNETICALLY LEVITATED DEVICES. THE AUTHORS DESCRIBED PATIENT DEATHS; THE CAUSES OF DEATH WERE DUE TO MAJOR BLEEDING EVENTS, UNSPECIFIED CIRCULATORY SYSTEM ISSUES, HEART FAILURE, MAJOR INFECTIONS, MULTIPLE ORGAN FAILURE, NEUROLOGIC DYSFUNCTION, RESPIRATORY FAILURE, SUDDEN DEATH, WITHDRAWAL OF SUPPORT, UNSPECIFIED DEVICE MALFUNCTIONS AND OTHER UNSPECIFIED CAUSES. THERE WERE PATIENTS WHO EXPERIENCED ARTERIAL NON-CNS/VENOUS THROMBOEMBOLISMS, PUMP THROMBUS, MAJOR DEVICE-RELATED/NON-DEVICE INFECTIONS, MAJOR BLEEDING WHICH REQUIRED RE-OPERATION, GASTROINTESTINAL BLEEDING, CARDIAC ARRHYTHMIAS, HEPATIC DYSFUNCTION, MYOCARDIAL INFARCTION, NEUROLOGIC DYSFUNCTION, STROKES, PERICARDIAL DRAINAGE, RENAL DYSFUNCTION, RESPIRATORY FAILURE, WOUND DEHISCENCE, AND OTHER UNKNOWN SERIOUS ADVERSE EVENTS. PATIENTS REQUIRED RE-HOSPITALIZATIONS, SURGICAL INTERVENTIONS, AND PERICARDIAL FLUID DRAINAGE AS TREATMENT. THERE WERE ALSO UNKNOWN DEVICE MALFUNCTIONS. 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
    464657 HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Death