BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 5075791 · Received September 14, 2015

    Report

    Report Number
    3007042319-2015-02178
    Event Type
    Death
    Date Received
    September 14, 2015
    Date of Event
    August 24, 2015
    Report Date
    August 24, 2015
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED: DATE OF DEATH WAS SAID TO BE (B)(6) 2015 AND THE OFFICIAL CAUSE OF DEATH WAS MULTI ORGAN FAILURE. IT WAS STATED FROM THE SITE THAT THE PUMP WAS RELATED TO THE DEATH. ALSO THAT THE "WHOLE PUMP AND DRIVELINE WERE INFECTED". THE INFECTION WAS DETERMINED TO HAVE BEEN CONTRIBUTED BY PATIENT WEIGHT GAIN. THE PUMP WAS EXCHANGED AND IT RESOLVED THE INFECTION. IT WAS ALSO STATED THAT PUMP THROMBUS WAS VISUALIZED DURING THE EXCHANGE. PUMP IS NOT BEING RETURNED BY THE SITE. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISE WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 1

    HVAD PUMP (B)(4) WAS NOT RETURNED TO HEARTWARE FOR EVALUATION. REVIEW OF THE MANUFACTURING DOCUMENTATION, DHR REVIEW, CONFIRMED THAT THE ASSOCIATED DEVICE MET ALL REQUIREMENTS FOR RELEASE. THE REPORTED EVENT WAS CONFIRMED VIA REVIEW OF THE CONTROLLER LOG FILES, WHICH REVEALED THE INCREASE IN POWER CONSUMPTION. ANALYSIS OF THE EXPLANTED PUMP BY THE SITE REVEALED THE PRESENCE OF A FOREIGN MATERIAL RESEMBLING A THROMBUS WITHIN THE PUMP. THE DEVICE WAS RELATED TO THE REPORTED EVENT; HOWEVER THERE IS NO EVIDENCE TO SUGGEST THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE MOST LIKELY ROOT CAUSE OF THE HIGH POWER EVENT IS THROMBUS FORMATION OR INGESTION WITHIN THE DEVICE. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 1

    THE HEARTWARE VAD 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, INCLUDING TRANSPORTATION. 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). BASED ON THE AVAILABLE INFORMATION A DEFINITIVE CONCLUSION CANNOT BE MADE REGARDING FACTORS POTENTIALLY CONTRIBUTING TO THE REPORTED SUSPECTED PUMP 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 MOBILITY. LOG FILE ANALYSIS REVIEW DATE: 08/03/2015; LOG FROM (B)(6) 2015: NORMAL POWER CONSUMPTION. ADDITIONAL NOTES: WAVEFORMS INDICATE A SLIGHT RISE IN POWER CONSUMPTION ON (B)(6) 2015. LOG FILE ANALYSIS REVIEW DATE: 08/24/2015; LOGS FROM (B)(6) 2015: NORMAL POWER CONSUMPTION. ADDITIONAL NOTES: A RISE IN POWER CONSUMPTION HAS BEEN LOGGED STARTING (B)(6) 2015. CURRENT PARAMETERS HAVE RETURNED TO POWER CONSUMPTION WITHIN NORMAL OPERATION. 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: {IT WAS STATED THAT WHEN PATIENT WAS ADMITTED THEY "FELT DIZZY." ON ADMISSION "INR 2.61, PTT 49, AND QUICK WAS 27%." IT WAS STATED ECHO WAS DONE (DATE UNKNOWN) AND DID NOT CONFIRM THROMBUS. ALSO A PET-CT WAS DONE WHICH CONFIRMED INFECTION. PATIENT WAS PLACED ON "ARGATROBAN AND ANTIBIOTICS." IT WAS STATED THAT DURING THE PUMP EXCHANGE THROMBUS WAS VISUALIZED AND THAT THERE WERE NO ISSUES DURING THE EXCHANGE. POST IMPLANT PATIENT "INR 1.6 AND PTT WAS 49." IT WAS FURTHER STATED THAT PATIENT EXPIRED (DATE UNKNOWN).} NO ADDITIONAL INFORMATION PROVIDED. INVESTIGATION IS ONGOING. 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

    IT WAS REPORTED FROM (B)(6) THAT PATIENT SHOWED "POWER CONSUMPTION RAISE IN LOG FILES OF (B)(6) 2015." "PATIENT WAS PUT ON AGATROBAN I.V. AND RECEIVED A PUMP EXCHANGE ON (B)(6) 2015." NO ADDITIONAL INFORMATION PROVIDED. INVESTIGATION IS ONGOING. LVAD IMPLANT DATE: (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606912 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Death