BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 4807357 · Received May 30, 2015

    Report

    Report Number
    3007042319-2015-00445
    Event Type
    Death
    Date Received
    May 30, 2015
    Date of Event
    October 1, 2014
    Report Date
    February 27, 2015
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD A MRSA DRIVELINE/DEVICE INFECTION AND DIED DURING TRANSPLANT DUE TO MRSA SEPSIS. DEATH DATE IS UNKNOWN. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 1

    AFTER REVIEW OF ADDITIONAL INFORMATION RECEIVED HAVE BEEN UPDATED ACCORDINGLY. THIS UPDATES DOES NOT IMPACT THE RESULT OF THE INVESTIGATION. 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 DEVICE IS NOT AVAILABLE FOR ANALYSIS AND THE SERIAL NUMBER IS NOT AVAILABLE, THEREFORE A DEVICE HISTORY RECORD REVIEW CANNOT BE PERFORMED. IT IS POSSIBLE THAT PATIENT COMORBIDITIES AND FACTORS RELATED TO DRIVELINE CARE MAY HAVE PUT HIM AT INCREASED RISK FOR INFECTION; HOWEVER, NO CONCLUSION CAN BE MADE. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. THIS IS NOT A DEVICE UNDER REMEDIAL ACTION/NOTIFICATION.

    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. INFECTION AND SPECIFICALLY DRIVELINE INFECTION IS A KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE IMPLANTATION OF ALL LVADS AS OUTLINED IN THE INSTRUCTIONS FOR USE (IFU). THE IFU ADDRESSES GUIDELINES FOR OPTIMAL PATIENT MANAGEMENT INCLUDING PRE AND POST-OPERATIVE INFECTION CONTROL MEASURES AND DRIVELINE CARE. ANY ADDITIONAL INFORMATION RECEIVED WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT WHEN THE MANUFACTURER'S INVESTIGATION HAS BEEN COMPLETED. THE COMPANY IS SEEKING THIS INFORMATION THROUGH THE EVENT INVESTIGATION. HEARTWARE IS SUBMITTING THIS REPORT LATE BECAUSE IT WAS DISCOVERED DURING ROUTINE COMPLAINT FILE INVESTIGATION ACTIVITIES, THAT 117 E-MDRS WERE SUBMITTED IN ERROR TO THE PRE-PRODUCTION E-MDR GATEWAY, (HTTPS://ESGTEST.FDA.GOV/UI/) INSTEAD OF THE E-MDR PRODUCTION GATEWAY (HTTPS://ESG.FDA.GOV/UI/), BETWEEN 18 MARCH AND 19 MAY 2015. THIS ERROR OCCURRED AS A RESULT OF SETTING UP A NEW E-ACCOUNT AND THE SUBSEQUENT TRAINING OF THE HEARTWARE COMPLAINT ANALYST. THE SITUATION HAS BEEN CORRECTED. THIS IS REPORT 111 OF 117 . DEVICE LOCATION IS UNKNOWN.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: BERNHARDT ET AL, (2014), ISOLATED PERMANENT RIGHT VENTRICULAR ASSIST DEVICE IMPLANTATION WITH THE HEARTWARE CONTINUOUS-FLOW VENTRICULAR ASSIST DEVICE: FIRST RESULTS FROM THE EUROPEAN REGISTRY FOR PATIENTS WITH MECHANICAL CIRCULATORY SUPPORT, EUROPEAN JOURNAL OF CARDIO-THORACIC SURGERY (2014) 1-4, DOI:10.1093/EJCTS/EZU406. ISOLATED RIGHT VENTRICULAR (RV) DYSFUNCTION WITH PRESERVED LEFT VENTRICULAR FUNCTION IS DIFFICULT TO TREAT AND ASSOCIATED WITH HIGH MORTALITY. TEMPORARY DEVICES FOR THE RIGHT VENTRICULAR SUPPORT [RIGHT VENTRICULAR ASSIST DEVICE (RVAD)] ARE AVAILABLE AND HAVE BEEN USED FOR SHORT-TERM RIGHT HEART ASSISTANCE. IN SOME PATIENT'S, RV FUNCTION DOES NOT RECOVER AND LONG-TERM DEVICES ARE NEEDED. RECENTLY, ISOLATED RVAD IMPLANTATION WITH A PERMANENT HEARTWARE VENTRICULAR ASSIST DEVICE (HVAD) HAS BEEN REPORTED IN PATIENTS WITH ACUTE RV INFARCTION AND CHRONIC GRAFT FAILURE. HOWEVER, ISOLATED IMPLANTATION ON THE RIGHT SIDE REMAINS RARE AND IS STILL AN OFF-LABEL USE FOR THIS PUMP. TO GATHER EUROPEAN DATA, WE QUERIED THE EUROPEAN REGISTRY FOR PATIENTS WITH MECHANICAL CIRCULATORY SUPPORT (EUROMACS) DATABASE, IN WHICH PROCEDURE AND OUTCOME DATA FOR PATIENTS RECEIVING MECHANICAL CIRCULATORY SUPPORT ARE REGISTERED. METHODS: UNTIL MAY 2014, DATA OF 8 PATIENTS (MEAN AGE 55.0 ± 17.3 YEARS, 100% MALES) WITH AN ISOLATED HVAD FOR RV SUPPORT WERE SUBMITTED TO THE EUROMACS REGISTRY. ALL PATIENTS WERE IN INTERMACS CLASSES 1-3. DEVICE STRATEGY WAS RESCUE THERAPY IN 6 PATIENTS (75.0%) AND DESTINATION THERAPY IN 2 PATIENTS (25.0%). INDICATIONS FOR RVAD PLACEMENT WERE ACUTE MYOCARDIAL INFARCTION IN 4 (50.0%), FAILURE TO WEAN FROM CARDIOPULMONARY BYPASS IN 2 (25.0%), AND POST-CARDIOTOMY RV FAILURE IN ANOTHER 2 PATIENTS (25.0%). INTRA- AND POSTOPERATIVE RESULTS OF THE EUROMACS REGISTRY WERE ANALYZED. RESULTS: INFLOW CANNULAS WERE IMPLANTED INTO THE RIGHT ATRIUM (RA) IN 6 PATIENTS (75.0%) AND INTO THE RV IN 2 PATIENTS (25.0%). CPB WAS USED IN 6 PATIENTS (75.0%). FOUR PATIENTS (50.0%) SURVIVED THE FIRST 30 DAYS. DURING FOLLOW-UP, 1 PATIENT DIED AFTER 44 DAYS DUE TO MULTI-ORGAN FAILURE. IN THE SURVIVING THREE PATIENTS, 2 PATIENTS WERE TRANSPLANTED AFTER 29 AND 419 DAYS, RESPECTIVELY, AND, IN 1 PATIENT, THE DEVICE WAS EXPLANTED FOR PUMP THROMBOSIS AND RECOVERED RV FUNCTION. CONCLUSION: IN THIS VERY SPECIFIC AND SICK PATIENT COHORT WITHIN THE EUROMACS REGISTRY, ISOLATED PERMANENT RVAD IMPLANTATION IS A NOVEL AND PROMISING STRATEGY FOR PATIENTS WITH ISOLATED RIGHT HEART FAILURE. HOWEVER, MORE EXPERIENCE IS NEEDED TO IDENTIFY PATIENTS WHO BENEFIT FROM THIS TECHNOLOGY. THIS REPORT IS FOR PATIENT #4, WHO WAS ON THE DEVICE FOR 419 DAYS DUE TO RCA DISSECTION, CABG FAILURE TO WEAN FROM CBP AND DEVELOPED A DRIVELINE INFECTION. THIS PATIENT WAS EVENTUALLY TRANSPLANTED. ARTICLE IS ATTACHED TO THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351336 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death| R