BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 6196127 · Received December 21, 2016

    Report

    Report Number
    3007042319-2016-04488
    Event Type
    Death
    Date Received
    December 21, 2016
    Date of Event
    December 1, 2016
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) WAS NOT RETURNED FOR EVALUATION. REVIEW OF THE MANUFACTURING RECORDS CONFIRMED THAT THE ASSOCIATED PUMP MET ALL REQUIREMENTS FOR RELEASE. LOG FILE ANALYSIS CONFIRMED THE REPORTED EVENT AS LOW FLOW AND HIGH WATT ALARMS ALONG WITH A RISE IN POWER CONSUMPTION TO PUMP PARAMETERS ABOVE THE NORMAL OPERATING RANGE WAS OBSERVED. THE MOST LIKELY ROOT CAUSE OF THE HIGH POWER EVENT CAN BE ATTRIBUTED TO EXTERNAL FACTORS SUCH AS THROMBUS FORMATION. A REVIEW OF THE AVAILABLE INFORMATION DOES NOT INDICATE ANY DEVICE MALFUNCTIONS OR PERFORMANCE ISSUES THAT WOULD IMPACT THE REPORTED EVENT. BASED ON THE AVAILABLE INFORMATION A DEFINITIVE CONCLUSION CANNOT BE MADE REGARDING FACTORS POTENTIALLY CONTRIBUTING TO THE REPORTED PUMP HIGH WATTS AND SUSPECTED THROMBUS; HOWEVER, IN ADDITION TO REQUIRED ADEQUATE ANTICOAGULATION, LVAD PUMP CANDIDATES OFTEN POSSESS SEVERAL RISK FACTORS FOR INTRAVASCULAR COAGULATION WHICH MAY INCLUDE ARTERIAL AND/OR VENOUS VASCULAR DISEASE, CHRONIC LOW FLOW STATE AND DECREASED IMMOBILITY. PHARMACOLOGICAL AND CLINICAL FACTORS RELATED TO ANTICOAGULATION THERAPY MAY ALSO HAVE CONTRIBUTED TO THE REPORTED EVENT.  THOUGH THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, THERE ARE PATIENT AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. 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. PER THE INSTRUCTIONS FOR USE (IFU): HIGH WATTS ALARMS, ARE AN INDICATION THAT THE PUMP WATTS HAS EXCEEDED THE HIGH POWER ALARM THRESHOLD, MAY BE INDICATIVE OF THROMBUS OR OTHER TISSUE FRAGMENTS IN THE PUMP, WHICH ARE KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH ALL PATIENTS IMPLANTED WITH VADS AS OUTLINED IN THE LABELING. THE IFU ADDRESSES SETTING PARAMETERS FOR THE HIGH POWER ALARM THRESHOLD, HOW TO RECOGNIZE HIGH WATT ALARMS AND GUIDELINES FOR OPTIMAL PATIENT MANAGEMENT (INCLUDING THERAPEUTIC ANTICOAGULATION GUIDELINES). THROMBUS IS A POTENTIAL EVENT THAT MAY BE ASSOCIATED WITH USE OF THE PRODUCT. THE INSTRUCTIONS FOR USE (IFU) AND PATIENT MANUAL PROVIDE GUIDELINES ON PROPER USAGE OF THE HVAD SYSTEM AND PROGRAMMING HVAD PUMP PARAMETERS. MOREOVER, THE IFU PROVIDES INSTRUCTION TO FURTHER EDUCATE THE PATIENT ABOUT PRODUCT SAFETY, ALARM MANAGEMENT, AND ANTICOAGULATION RECOMMENDATIONS. THE INSTRUCTIONS FOR USE (IFU) ADDRESSES GUIDELINES FOR OPTIMAL PATIENT MANAGEMENT INCLUDING HAVING ADEQUATE AND STABLE PRELOAD AVAILABLE. DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON JANUARY 3RD, 2017 INDICATED THAT THE PATIENT'S FAMILY DID NOT AUTHORIZE AN AUTOPSY. THE PATIENT HAD MULTI-ORGAN FAILURE ON (B)(6) 2016, DESPITE ALL SUPPORT MEASURES, SUCH AS EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) AND INOTROPIC SUPPORT (NORADRENALINE 2,5 MCG/KG/MIN, DOBUTAMINE 33 MCG/KG/MIN). PICTURES WERE PROVIDED OF THE UNMOUNTED PUMP. THE PUMP WILL NOT BE RETURNED BY THE SITE. (B)(4) WAS NOT RETURNED FOR EVALUATION. REVIEW OF THE MANUFACTURING RECORDS CONFIRMED THAT THE ASSOCIATED PUMP MET ALL REQUIREMENTS FOR RELEASE. LOG FILE ANALYSIS CONFIRMED THE REPORTED EVENT AS LOW FLOW AND HIGH WATT ALARMS ALONG WITH A RISE IN POWER CONSUMPTION TO PUMP PARAMETERS ABOVE THE NORMAL OPERATING RANGE WAS OBSERVED. PICTURES SUBMITTED BY THE SITE CONFIRMED THROMBUS WITHIN THE PUMP. THE MOST LIKELY ROOT CAUSE OF THE HIGH POWER EVENT CAN BE ATTRIBUTED TO EXTERNAL FACTORS SUCH AS THROMBUS FORMATION. A REVIEW OF THE AVAILABLE INFORMATION DOES NOT INDICATE ANY DEVICE MALFUNCTIONS OR PERFORMANCE ISSUES THAT WOULD IMPACT THE REPORTED EVENT. BASED ON THE AVAILABLE INFORMATION A DEFINITIVE CONCLUSION CANNOT BE MADE REGARDING FACTORS POTENTIALLY CONTRIBUTING TO THE REPORTED PUMP HIGH WATTS AND SUSPECTED THROMBUS; HOWEVER, IN ADDITION TO REQUIRED ADEQUATE ANTICOAGULATION, LVAD PUMP CANDIDATES OFTEN POSSESS SEVERAL RISK FACTORS FOR INTRAVASCULAR COAGULATION WHICH MAY INCLUDE ARTERIAL AND/OR VENOUS VASCULAR DISEASE, CHRONIC LOW FLOW STATE AND DECREASED IMMOBILITY. PHARMACOLOGICAL AND CLINICAL FACTORS RELATED TO ANTICOAGULATION THERAPY MAY ALSO HAVE CONTRIBUTED TO THE REPORTED EVENT.  THOUGH THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, 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

    A REPORT WAS RECEIVED THAT THE PATIENT PRESENTED TO THE HOSPITAL WITH HIGH POWER ALARMS. PRELIMINARY LOG FILE ANALYSIS CONDUCTED ON DECEMBER 1ST, 2016 CONFIRMED A RISE IN POWER CONSUMPTION.  THE SITE SUSPECTED PUMP THROMBUS AND THE PATIENT WAS TREATED WITH THROMBOLYSIS.  PUMP PARAMETERS RETURNED TO NORMAL VALUES FOLLOWING FIBRINOLYSIS THERAPY. INFORMATION PROVIDED ON DECEMBER 4TH, 2016 INDICATED THAT THE PATIENT WAS ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). LOG FILE ANALYSIS PERFORMED ON DECEMBER 4TH, 2016 SHOWED THAT THERE HAS BEEN AN INCREASING TREND IN POWER OUTSIDE OF NORMAL OPERATION STARTING (B)(6) 2016. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT RECEIVED A SECOND BOLUS OF THROMBOLYSIS DUE TO RECURRENT INCREASES IN PUMP POWER. THE SECOND DOSE WAS UNSUCCESSFUL AND THE PATIENT WAS THEN PLACED ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT.  THE PATIENT SUBSEQUENTLY DEVELOPED RENAL AND LIVER FAILURE AND ECMO SUPPORT WAS DISCONTINUED.  THE LAST REPORT RECEIVED BY THE DISTRIBUTER INDICATED THAT THE PATIENT EXPIRED ON SATURDAY (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843288 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM, BATTERY DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Death