BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE

    MDR report key: 20771552 · Received November 25, 2024

    Report

    Report Number
    3007042319-2024-05128
    Event Type
    Injury
    Date Received
    November 25, 2024
    Date of Event
    October 2, 2024
    Report Date
    November 25, 2024
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    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. THE EVENT ONLY OCCURRED WITH ONE PATIENT BUT SPECIFIC DETAILS ON THE PATIENT WERE NOT PROVIDED. 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: ACUTE HEART FAILURE WITH UNILATERAL PULMONARY EDEMA DUE TO AORTIC INSUFFICIENCY DURING LVAD SUPPORT. JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY: JACC CASE REPORTS. 2024; 29: 102584) DOI: 10.1016/J.JACCAS.2024.102584 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 UNILATERAL PULMONARY EDEMA (UPE) DUE TO AORTIC INSUFFICIENCY WITH VENTRICULAR ASSIST DEVICE (VAD) SUPPORT. THE AUTHORS DESCRIBED A PATIENT WHO WAS ADMITTED TO THE CARDIAC CARE UNIT AFTER PRESENTING TO THE EMERGENCY DEPARTMENT WITH SEVERE SHORTNESS OF BREATH. THE NIGHT BEFORE PRESENTATION THEY DEVELOPED NON-BLOODY, NONBILIOUS EMESIS AND A PRODUCTIVE COUGH. THEIR CURRENT EXAMINATION SHOWED TACHYPNEA, DIFFUSE CRACKLES ON AUSCULTATION, ABSENCE OF A PALPABLE PULSE, AND ABDOMINAL TENDERNESS AT THE DRIVELINE INSERTION SITE WITHOUT GUARDING. THE PATIENT'S HISTORY NOTED NUMEROUS CLINICAL COMPLICATIONS WHICH INCLUDED MULTIPLE CEREBROVASCULAR ACCIDENTS WITHOUT RESIDUAL DEFICITS, GASTROINTESTINAL BLEED (GIB), CHRONIC DRIVELINE INFECTION TREATED WITH INCISION AND DRAINAGE AS WELL AS CHRONIC ANTIBIOTICS, AND EPISODES OF VENTRICULAR ARRHYTHMIA. ELECTROCARDIOGRAM RESULTS SHOWED SINUS TACHYCARDIA AND A CHEST X-RAY DISPLAYED A UNILATERAL, RIGHT-SIDED INFILTRATES WITH A MODERATE SIZE PLEURAL EFFUSION. TRANSTHORACIC ECHOCARDIOGRAPHY DEPICTED SEVERE LEFT VENTRICULAR (LV) SYSTOLIC DYSFUNCTION WITH CLOSED AORTIC VALVE ON ALL OBSERVED BEATS, MODERATE-SEVERE AORTIC INSUFFICIENCY (AI), MODERATE-SEVERE TRICUSPID REGURGITATION, AND SEVERE MITRAL REGURGITATION (MR). A POINT-OF-CARE CHEST ULTRASOUND REVEALED UNILATERAL, RIGHT-SIDED SMALL PLEURAL EFFUSION AND LUNG CONSOLIDATION REPRESENTING ATELECTASIS OR PNEUMONIA. THE PATIENT WAS STARTED ON INTRAVENOUS (IV) ANTIBIOTICS FOR SEVERE PNEUMONIA. A RAMP STUDY WITH RIGHT-HEART CATHETERIZATION WAS PERFORMED AND THEY INCREASED THE PUMP SPEED WHICH LED TO A NOTABLE REDUCTION OF OPENING PULMONARY CAPILLARY WEDGE PRESSURE (PCWP). THE PATIENT WAS DIAGNOSED WITH UNILATERAL PULMONARY EDEMA DUE TO AORTIC INSUFFICIENCY IN THE SETTING OF INADEQUATE LV UNLOADING. A FOLLOW-UP C HEST X-RAY ONE DAY AFTER THE PUMP SPEED WAS INCREASED SHOWED IMPROVEMENT OF THE RIGHT-SIDED PULMONARY EDEMA WITH NO PLEURAL EFFUSION. THE DEVICE REMAINS IN USE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1786681 HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Hospitalization| R