BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

    MDR report key: 20525926 · Received October 24, 2024

    Report

    Report Number
    3007042319-2024-04703
    Event Type
    Death
    Date Received
    October 24, 2024
    Date of Event
    February 28, 2024
    Report Date
    October 24, 2024
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. 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/68 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: CURTIS, B., DESHMUKH, A., LARSON, J. ET AL. "SAFETY AND HEMODYNAMIC IMPLICATIONS OF TRANSSEPTAL ACCESS FOR VENTRICULAR TACHYCARDIA ABLATION IN PATIENTS WITH LEFT VENTRICULAR ASSIST DEVICES." JOURNAL OF INTERVENTIONAL CARDIAC ELECTROPHYSIOLOGY. 2024. DOI:10.1007/S1 0840-024-01768-0. 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 AND HEMODYNAMIC IMPLICATIONS OF TRANSSEPTAL ACCESS FOR VENTRICULAR TACHYCARDIA (VT) ABL ATION IN PATIENTS WITH LEFT VENTRICULAR ASSIST DEVICES (VADS). THE AUTHORS DESCRIBED PATIENT DEATHS; THE CAUSE OF DEATH FOR ONE PATIENT WAS RECURRENT VT AND THE OTHER CAUSES OF DEATH WERE UNKNOWN. THE PATIENTS EXPERIENCED VENTRICULAR TACHYCARDIA (VT) AND WERE TREATED WITH CATHETER ABLATION. THERE WERE PATIENTS WHO EXPERIENCED PULMONARY HYPERTENSION, MODERATE OR SEVERE RIGHT VENTRICLE (RV) DYSFUNCTION, SUSTAINED MONOMORPHIC VT, VT STORM AND VENTRICULAR ANEURYSM. ALL PATIENTS HAD PREVIOUS FAILED TREATMENT WITH AN ANTI-ARRHYTHMIC DRUG. ONE PATIENT EXPERIENCED PROCEDURAL COMPLICATIONS REQUIRING EMBOLIZATION FOR BLEEDING FROM INTERCOSTAL INJURY. THE STATUS OF THE DEVICES IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1790006 HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Death