BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 4782596 · Received May 19, 2015

    Report

    Report Number
    3007042319-2015-00923
    Event Type
    Death
    Date Received
    May 19, 2015
    Date of Event
    May 4, 2015
    Report Date
    May 6, 2015
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT EXPIRED IN (B)(6) 2015. EXACT DATE IS UNKNOWN. GASTROINTESTINAL BLEEDING HAS BEEN IDENTIFIED AS A KNOWN POTENTIAL RISK ASSOCIATED WITH USE OF ALL VADS AS OUTLINED IN THE INSTRUCTIONS FOR USE (IFU). ALTHOUGH THIS EVENT IS LIKELY RELATED TO THE DEVICE SUPPORT AND REQUIRED ANTICOAGULANT THERAPY, THERE IS NO EVIDENCE TO SUGGEST A RELATIONSHIP TO ANY DEVICE PERFORMANCE OR MANUFACTURING ISSUES. KNOWN CONTRIBUTING FACTORS TO GI BLEEDING INCLUDE INDIVIDUAL PATIENT COMORBIDITIES AND PHARMACOLOGICAL FACTORS. THE IFU ADDRESSES GUIDELINES FOR OPTIMAL PATIENT MANAGEMENT, INCLUDING THERAPEUTIC ANTICOAGULATION GUIDELINES. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. THE VENTRICULAR ASSIST SYSTEM IS INDICATED FOR USE AS A BRIDGE TO CARDIAC TRANSPLANTATION IN PATIENTS WHO ARE AT RISK OF DEATH FROM REFRACTORY END-STAGE LEFT VENTRICULAR HEART FAILURE. THE SYSTEM IS DESIGNED FOR IN-HOSPITAL AND OUT-OF-HOSPITAL SETTINGS. IFU: ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF VENTRICULAR ASSIST DEVICES, OTHER THAN DEATH, INCLUDE HEMOLYSIS AND RESPIRATORY DYSFUNCTION. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. THE COMPANY IS SEEKING THIS INFORMATION THROUGH THE EVENT INVESTIGATION. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM (B)(6) BY A PHYSICIAN THAT THIS PATIENT WAS ADMITTED POSTOPERATIVELY, AFTER A PUMP EXCHANGE, TO ICU WITH BLEEDING ISSUES IN THE LEFT LUNG. ECLS IS IN PLACE. NO OTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    THE NEW PUMP WAS IMPLANTED WITH A LEFT THORACOTOMY AND ANASTOMOSES TO DESCENDING AORTA. BLEEDING OCCURRED AFTER ATTACHING CPB, X-RAY "OF LUNGS SHOWED AS WHITE BEFORE SURGERY". CENTRAL ECLS IS SUCCESSFUL WEANED AND REMOVED, THE PATIENT WAS STABILIZED. IT HAS BEEN REPORTED THAT THE PATIENT WAS CRITICALLY ILL AND EXPIRED (B)(6) 2015 OF MULTI ORGAN FAILURE. NO ADDITIONAL INFORMATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324930 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Death