BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

    MDR report key: 10251408 · Received July 9, 2020

    Report

    Report Number
    3007042319-2020-04340
    Event Type
    Injury
    Date Received
    July 9, 2020
    Date of Event
    January 1, 2019
    Report Date
    July 9, 2020
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    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 WAS NOT RETURNED FOR EVALUATION. THE REPORTED HIGH POWER EVENT WAS NOT CONFIRMED VIA REVIEW OF THE CONTROLLER LOG FILES SINCE LOG FILES COVERING THE REPORTED EVENT DATE WERE NOT AVAILABLE FOR ANALYSIS. OF NOTE, IT WAS REPORTED THAT HEPARIN WAS ADMINISTERED. THERE IS NO EVIDENCE TO SUGGEST THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE HISTORICAL REVIEW OF SIMILAR HIGH POWER EVENTS, THE MOST LIKELY ROOT CAUSE OF THE HIGH POWER EVENT MAY BE ATTRIBUTED TO THROMBUS FORMATION/INGESTION. 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 Q1 2020 INTERMACS 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 WAS HOSPITALIZED WITH SUBTHERAPEUTIC INTERNATIONAL NORMALIZED RATIO (INR), INCREASING LACTATE DEHYDROGENASE (LDH), HEMOLYSIS, AND SLOWLY RISING VENTRICULAR ASSIST DEVICE (VAD) POWER. IT WAS SUSPECTED THAT VAD HAD THROMBUS AT THE OUTFLOW CANNULA. ECHOCARDIOGRAM REVEALED TURBULENCE IN THE OUTFLOW CANNULA WITH INCREASED VELOCITY DUE TO THROMBUS. THE PATIENT WAS ADMINISTERED ASPIRIN, HEPARIN, PLAVIX, AND WARFARIN DURING HIS HOSPITALIZATION, RESULTING IN A DECREASE OF LACTATE DEHYDROGENASE (LDH) VALUES. THE VAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. THIS EVENT WAS REPORTED IN THE Q1 2020 INTERMACS 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
    713859 HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP VENTRICULAR (ASSIST) BYPASS DSQ HEARTWARE, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| L| R