BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM- PUMP

    MDR report key: 7971595 · Received October 16, 2018

    Report

    Report Number
    3007042319-2018-04867
    Event Type
    Death
    Date Received
    October 16, 2018
    Date of Event
    July 1, 2018
    Report Date
    October 30, 2018
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    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. THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE SERIAL NUMBERS. THE BASELINE GENDER/AGE OF THE PATIENTS REPRESENTED IN THE ARTICLE IS MALE/(B)(6) YEARS OLD. THE DATES OF DEATH ARE 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. REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: HEMODYNAMIC ASSESSMENT OF PATIENTS WITH AND WITHOUT HEART FAILURE SYMPTOMS SUPPORTED BY A CONTINUOUS-FLOW LEFT VENTRICULAR ASSIST DEVICE. MAYO CLINIC PROCEEDINGS, 2018 JUL 01; 97(7):895-903. DOI:10.1016/J.MAYOCP.2018.01.031. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: A PUMP WITH UNKNOWN SERIAL NUMBER WAS NOT RETURNED FOR EVALUATION. REVIEW OF STERILITY CERTIFICATES COULD NOT BE PERFORMED SINCE THE SERIAL NUMBER OF THE DEVICE IS UNKNOWN. THE REPORTED EVENT CANNOT BE CONFIRMED DUE TO INSUFFICIENT INFORMATION. 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING VENTRICULAR ASSIST DEVICES (VADS). THE ARTICLE DISCUSSED VADS FOR LEFT VENTRICULAR SUPPORT IN ADULTS AND OUTCOMES IN PATIENTS WITH AND WITHOUT HEART FAILURE SYMPTOMS AFTER VAD IMPLANTATION. MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE-TO-ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE SERIAL NUMBERS. PUMP THROMBOSES WERE DIAGNOSED BY THE PRESENCE OF HEMOLYSIS, ELEVATED LACTATE DEHYDROGENASE (LDH) AND ABNORMAL PUMP FUNCTION. THE ARTICLE REPORTS PATIENT DEATHS WHILE ON VAD SUPPORT, FROM MULTIORGAN FAILURE, INTRACRANIAL BLEEDING, HEART FAILURE, STROKE, RESPIRATORY FAILURE AND PUMP THROMBOSIS. THE STATUS/LOCATION OF THE VADS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809658 HEARTWARE VENTRICULAR ASSIST SYSTEM- PUMP VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. UNK-PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death