BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 5932608 · Received September 7, 2016

    Report

    Report Number
    3007042319-2016-03160
    Event Type
    Injury
    Date Received
    September 7, 2016
    Date of Event
    August 21, 2016
    Report Date
    August 21, 2016
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    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 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. THROMBUS AS 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. 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). DEATH IS A POTENTIAL EVENT THAT MAY BE ASSOCIATED WITH USE OF THE PRODUCT. CLINICAL RESULTS AND COMMERCIAL EXPERIENCE DEMONSTRATE THAT THE PLACEMENT OF A VAD IN CHRONIC NYHA CLASS IV PATIENTS IMPROVES SURVIVAL AND QUALITY OF LIFE WHEN COMPARED TO A SIMILAR PATIENT POPULATION RECEIVING CONVENTIONAL THERAPY. FURTHERMORE, THESE BENEFITS APPLY TO PATIENTS BEING BRIDGED TO HEART TRANSPLANT, PATIENTS RECEIVING PERMANENT SUPPORT (DESTINATION THERAPY), AND THOSE BEING SUPPORTED WITH THE EXPECTATION FOR MYOCARDIAL RECOVERY. (B)(4). ADDITIONAL SYSTEM COMPONENT BEING REPORTED FOR THIS EVENT: PUMP: (B)(4) - EXPIRATION DATE: 12-31-20217, MANUFACTURER DATE-12-31-2015. (B)(4). HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 1

    UPDATED: MODEL/LOT #, DATE RECEIVED BY MFR, TYPE OF REPORTS, IF FOLLOW-UP, WHAT TYPE?, EVALUATION CODES, ADDITIONAL MFR NARRATIVE. ADDITIONAL SYSTEM COMPONENT BEING REPORTED FOR THIS EVENT: PUMP: (B)(4) CORRECTION: MFR DATE IS : 01/13/2016. (B)(4). THROMBUS FORMATION IS A POTENTIALLY LIFE THREATENING EVENT THAT HAS BEEN ASSOCIATED WITH USE OF THIS DEVICE. A USER MUST FULLY CONSIDER THE RISKS OF THIS DEVICE WITH THAT OF OTHER TREATMENT MODALITIES BEFORE DECIDING TO PROCEED WITH DEVICE IMPLANTATION. LVAD PUMP (B)(4) AND RVAD PUMP (B)(4) WERE NOT RETURNED FOR EVALUATION. REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT THE ASSOCIATED DEVICES MET ALL REQUIREMENTS FOR RELEASE. REVIEW OF CONTROLLER LOG FILES FOR (B)(4) REVEALED A DECREASE IN POWER CONSUMPTION THAT STARTED ON (B)(6) 2016. REVIEW OF CONTROLLER LOG FILES FOR (B)(4) REVEALED A RISE IN POWER CONSUMPTION STARTING ON (B)(6) 2016; THUS CONFIRMING THE REPORTED EVENT. THERE IS NO EVIDENCE TO SUGGEST THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. HOWEVER, THE MOST LIKELY ROOT CAUSE OF THE HIGH POWER CAN BE ATTRIBUTED TO EXTERNAL FACTORS LIKE THROMBUS FORMATION/INGESTION. THE MOST LIKELY ROOT CAUSE OF THE INADEQUATE FLOW RATE CAN BE ATTRIBUTED TO FACTORS SUCH AS BUT NOT LIMITED TO OCCLUSION/SUCTION EVENT THAT MIGHT HAVE OCCURRED DUE TO THE INGESTION/FORMATION OF THROMBUS AT THE INFLOW CANNULA. WITH A REVIEW OF THE AVAILABLE INFORMATION THERE IS NO INDICATION OF ANY DEVICE MALFUNCTIONS OR PERFORMANCE ISSUES THAT WOULD IMPACT THE EVENT. THERE IS ALSO NO CLINICAL EVIDENCE TO SUGGEST THAT A MALFUNCTION OF THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE CONCLUSIVELY DETERMINED; THOUGH, CLINICAL FACTORS THAT MAY HAVE CONTRIBUTED INCLUDE THE PATIENT'S PREVIOUS MEDICAL HISTORY, ANTICOAGULANT THERAPY AND RELATED COMORBIDITIES. THERE ARE PATIENT, PROCEDURAL AND PHARMACOLOGICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PATIENT BEGAN EXPERIENCING AN INCREASE IN POWER CONSUMPTION, UP TO 8W (BASELINE 3.5W), WITH A LACTATE DEHYDROGENASE (LDH) OF 800 ON (B)(6) 2016. THERE WAS NO EVIDENCE OF HEMATURIA AT THE TIME. PER THE VAD COORDINATOR, THE PATIENT HAD NEVER BEEN THERAPEUTIC WITH HIS INR SINCE IMPLANT ((B)(6) 2016), AND HE HAD NOT HAD ASPIRIN (ASA) FOR "MULTIPLE DAYS" LEADING UP TO (B)(6) 2016 DUE TO MULTIPLE BLEEDING COMPLICATIONS. ON (B)(6) 2016, THE PATIENT WAS STARTED ON A TISSUE PLASMINOGEN ACTIVATOR (TPA) DRIP, POWER HAD PEAKED AT 22W, AND WAS NOW DECREASING BACK TO 10W, WITH LDH "TOO HEMOLIZED TO READ". ON (B)(6) 2016, THE PATIENT BEGAN HAVING SUCTION EVENT ON THE LEFT SIDE (LVAD PUMP SERIAL # (B)(4)). COORDINATOR CONFIRMED ECHO SHOWED "A LOT OF CLOT IN THE RIGHT HEART". THE PATIENT HAD ALSO HAD A BLEED IN HIS LEFT CHEST, AND VENTRICULAR TACHYCARDIA (VT). THE CLINICAL TEAM WAS ABLE TO RETURN PATIENT TO NORMAL SINUS RHYTHM (NSR). THE PATIENT'S LVAD RPMS DECREASED FROM 2900 TO 2500, AND COORDINATOR REPORTED INCREASED FLOW AND RETURN OF NORMAL WAVEFORM. HE WAS PLACED ON CONTINUOUS VENOVENOUS HEMODIALYSIS (CVVHD) DUE TO ANURIA. RVAD WATTS DECREASED TO 5W ON (B)(6) 2016. THE PATIENT EXPIRED ON (B)(6) 2016. THE OFFICIAL CAUSE OF DEATH IS BIVENTRICULAR HEART FAILURE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584807 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Death