BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM - PUMP

    MDR report key: 6895371 · Received September 26, 2017

    Report

    Report Number
    3007042319-2017-03376
    Event Type
    Death
    Date Received
    September 26, 2017
    Date of Event
    November 22, 2014
    Report Date
    March 30, 2018
    Manufacturer
    HEARTWARE
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INT J ARTIF ORGANS 2017; 00(00): 000-000. IJAO ISSN 0391-3988. DOI: 10.5301/IJAO.5000626. THROMBOSIS IN LEFT VENTRICULAR ASSISTANCE DEVICE WITH CENTRIFUGAL TECHNOLOGY: IS EARLY THROMBOLYSIS A BETTER SOLUTION? PAOLO CENTOFANTI, ANDREA BARONETTO, MATTEO ATTISANI, DAVIDE RICCI, ERIKA SIMONATO, MICHELE W. LA TORRE, MASSIMO BOTTINI, MAURO RINALDI. 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. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE PATIENT UNDERWENT CARDIAC TRANSPLANTATION. THE PATIENT IS REPORTED TO HAVE SUBSEQUENTLY EXPIRED. THE CAUSE OF DEATH WAS REPORTED TO BE TRANSPLANT. NO FURTHER INFORMATION HAS BEEN PROVIDED. (B)(4). HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISE WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 1

    THE PUMP WAS NOT RETURNED FOR EVALUATION. REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT THE ASSOCIATED DEVICE MET ALL REQUIREMENTS FOR RELEASE. THE REPORTED EVENT WAS NOT CONFIRMED VIA REVIEW OF THE CONTROLLER LOG FILES SINCE LOG FILES COVERING THE REPORTED EVENT DATE WERE NOT AVAILABLE FOR ANALYSIS. THERE IS NO EVIDENCE TO SUGGEST THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. BASED ON RISK DOCUMENTATION, MULTIPLE FACTORS MAY HAVE CONTRIBUTED TO THE HIGH POWER EVENT INCLUDING BUT NOT LIMITED TO THROMBUS FORMATION/INGESTION AND/OR HIGH FLOWS. 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 RECEIVED THAT INCLUDED A REPORT OF A PATIENT WHO EXPERIENCED A DEVICE THROMBOSIS. THIS ARTICLE DISCUSSED A CONSERVATIVE APPROACH TO PATIENTS PRESENTING WITH A SUSPECTED AND/OR CONFIRMED DEVICE THROMBOSIS AFTER LVAD IMPLANTATION AT ONE INSTITUTION IN A RETROSPECTIVE REVIEW. BETWEEN (B)(6) 2010 AND (B)(6) 2016, 32 PATIENTS WERE IMPLANTED WITH A VAD. THESE PATIENTS INCLUDED 14 PATIENTS WITH A HISTORY OF IDIOPATHIC CARDIOMYOPATHY, 17 PATIENTS WITH ISCHEMIC CARDIOMYOPATHY AND 1 PATIENT WITH POST-VALVULAR CARDIOMYOPATHY. THESE PATIENTS WERE ALSO REPORTED TO HAVE A MEAN AGE OF 59 YEARS AND 27 OF THEM WERE REPORTED TO HAVE BEEN MALE. THE ARTICLE INCLUDES A REPORT OF ONE OF THESE PATIENTS WHO DEVELOPED DEVICE THROMBOSIS ON (B)(6) 2014 WITH ELEVATED VAD PARAMETERS AND EVIDENCE OF HEMOLYSIS. THE PATIENT WAS TREATED WITH THROMBOLYSIS AND HEPARIN. THIS TREATMENT IS REPORTED TO HAVE BEEN SUCCESSFUL AT THAT TIME. THE PATIENT IS REPORTED TO HAVE SUBSEQUENTLY UNDERGONE A CARDIAC TRANSPLANTATION. THE AUTHORS CONCLUDED THAT SYSTEMIC THROMBOLYSIS WITH HEPARIN WAS AN EXCELLENT THERAPEUTIC OPTION. EARLY INTERVENTION IN CLINICALLY STABLE PATIENTS WITHOUT SIGNS OF HEART FAILURE BUT WITH INDIRECT SIGNS OF DEVICE THROMBOSIS HAS LED TO BETTER OUTCOMES. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL RELEVANT INFORMATION REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673452 HEARTWARE® VENTRICULAR ASSIST SYSTEM - PUMP CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Death| H| L| R