BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

    MDR report key: 21891581 · Received April 23, 2025

    Report

    Report Number
    3007042319-2025-00817
    Event Type
    Malfunction
    Date Received
    April 23, 2025
    Date of Event
    January 1, 2023
    Report Date
    June 19, 2025
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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/57 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. REFERENCED ARTICLE: THE SOCIETY OF THORACIC SURGEONS INTERMACS 2022 ANNUAL REPORT: FOCUS ON THE 2018 HEART TRANSPLANT ALLOCATION SYSTEM. THE ANNALS OF THORACIC SURGERY. 2023; 115:311-28. DOI: 10.1016/J.ATHORACSUR.2022.11.023 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.

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR CORRECTION TO FDA CONCLUSION CODE. CORRECTION: H6 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 IN THE RECENT (2017-2021) VERSUS PRIOR (2012-2016) ERAS. THE AUTHORS DESCRIBED PATIENT DEATHS; THE CAUSES OF DEATH WERE DUE TO BLEEDING, 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/VENOUS THROMBOEMBOLISMS, PUMP THROMBI, MAJOR DEVICE-RELATED/NON-DEVICE INFECTIONS, MAJOR BLEEDING, GASTROINTESTINAL BLEEDING, CARDIAC ARRHYTHMIAS, HEPATIC DYSFUNCTION, NEUROLOGIC DYSFUNCTION, STROKES, PERICARDIAL FLUID BUILDUP, RENAL DYSFUNCTION, RESPIRATORY FAILURE AND WOUND DEHISCENCE. 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
    1271771 HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male