BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

    MDR report key: 8551714 · Received April 25, 2019

    Report

    Report Number
    3007042319-2019-06178
    Event Type
    Injury
    Date Received
    April 25, 2019
    Report Date
    April 25, 2019
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    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 AND DESTINATION THERAPY 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. PRODUCT EVENT SUMMARY: A PUMP WITH UNKNOWN SERIAL NUMBER REMAINS IMPLANTED AND THUS WAS NOT RETURNED FOR EVALUATION. LOG FILE ANALYSIS COULD NOT BE PERFORMED SINCE LOG FILES COVERING THE REPORTED EVENT DATE WERE NOT AVAILABLE FOR ANALYSIS. THE REPORTED EVENT COULD NOT BE CONFIRMED DUE TO INSUFFICIENT EVIDENCE. BASED ON THE INVESTIGATION CONDUCTED, THERE IS NO EVIDENCE TO SUGGEST THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. POSSIBLE CLINICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT INCLUDE THE PATIENT¿S PRE-EXISTING HISTORY AND RELATED COMORBIDITIES, THE PROGRESSION OF THEIR UNDERLYING DISEASE, ISSUES RELATED TO THE THERAPEUTIC USE OF ANTICOAGULANT AND ANTIPLATELET MEDICATIONS AND THE PATIENT'S COMPLEX POST-OPERATIVE COURSE.  THERE ARE POSSIBLE PATIENT, PHARMACOLOGICAL AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. THIS EVENT WAS REPORTED IN THE (B)(6) DATA REGISTRY THAT TRACKS CLINICAL OUTCOMES OF PATIENTS ON VENTRICULAR ASSIST DEVICE (VAD) SUPPORT. THE DATA REGISTRY DOES NOT CONTAIN DEVICE IDENTIFYING INFORMATION OR EVENT DATE AND THEREFORE CANNOT BE CORRELATED TO ANY PREVIOUSLY RECEIVED REPORT OF THE EVENT. BASED ON THE PROVIDED DATA, DEVICE ANALYSIS WILL NOT BE POSSIBLE AND NO FURTHER INFORMATION WILL LIKELY BE MADE AVAILABLE CONCERNING THE EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD ELEVATED LACTATE DEHYDROGENASE (LDH) AND FREE HEMOGLOBIN(FHB) WITH COMPLAINTS OF HEMATURIA. THERE WAS A SUSPECTED PUMP THROMBUS AND THE PATIENT WAS HOSPITALIZED. THE VENTRICULAR ASSIST DEVICE (VAD) PARAMETERS WERE INTERROGATED AND THEY WERE ALL WITHIN NORMAL RANGE. THE VAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THIS EVENT WAS REPORTED IN THE (B)(6) DATA REGISTRY THAT TRACKS CLINICAL OUTCOMES OF PATIENTS ON VENTRICULAR ASSIST DEVICE (VAD) SUPPORT. THE DATA REGISTRY DOES NOT CONTAIN DEVICE IDENTIFYING INFORMATION OR EVENT DATE AND THEREFORE CANNOT BE CORRELATED TO ANY PREVIOUSLY RECEIVED REPORT OF THE EVENT. BASED ON THE PROVIDED DATA, DEVICE ANALYSIS WILL NOT BE POSSIBLE AND NO FURTHER INFORMATION WILL LIKELY BE MADE AVAILABLE CONCERNING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343346 HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP VENTRICULAR (ASSIST) BYPASS DSQ HEARTWARE, INC. UNK-PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| L