BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 5551225 · Received April 6, 2016

    Report

    Report Number
    3007042319-2016-01524
    Event Type
    Injury
    Date Received
    April 6, 2016
    Date of Event
    August 5, 2015
    Report Date
    January 27, 2016
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    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. RIGHT HEART FAILURE IS A POTENTIAL EVENT THAT MAY BE ASSOCIATED WITH USE OF THE PRODUCT. RIGHT HEART FAILURE USUALLY DEVELOPS WITHIN THE FIRST 24 HOURS AFTER LVAD IMPLANT. THE IFU PROVIDES GUIDELINES ON MANAGEMENT OF RIGHT HEART FAILURE. PATIENTS IMPLANTED WITH VAD'S OFTEN HAVE PREEXISTING CONDITIONS THAT MAY EXACERBATE RIGHT HEART FAILURE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT WAS TAKEN FOR RIGHT HEART CATHETERIZATION AND WAS DISCHARGED ON (B)(6) 2015. WITH A REVIEW OF THE AVAILABLE INFORMATION THERE IS NO EVIDENCE TO INDICATE ANY DEVICE MALFUNCTIONS OR PERFORMANCE ISSUES THAT WOULD IMPACT THE REPORTED EVENT. THERE IS ALSO NO CLINICAL EVIDENCE TO SUGGEST THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE AVAILABLE INFORMATION A DEFINITIVE ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED. CLINICAL FACTORS THAT MAY HAVE CONTRIBUTED INCLUDE THE PATIENT'S PRE-EXISTING CONDITIONS, RECENT DIAGNOSIS OF RIGHT HEART FAILURE POST LVAD IMPLANT PROCEDURE, MEDICAL MANAGEMENT, PROGRESSION OF DISEASE, AND PATIENT COMORBIDITIES. THERE ARE PATIENT AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM THE CLINICAL STUDY THAT THIS PATIENT IMPLANTED VIA THORACOTOMY APPROACH WAS READMITTED TO THE HOSPITAL FOR TREATMENT OF RIGHT HEART FAILURE THE PATIENT WAS TAKEN FOR RIGHT HEART CATHETERIZATION; RESULTS WERE NOT PROVIDED. THE PATIENT WAS DISCHARGED TO A REHABILITATION CENTER ON (B)(6) 2015. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207151 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| L| R