BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM - PUMP

    MDR report key: 6695292 · Received July 7, 2017

    Report

    Report Number
    3007042319-2017-02113
    Event Type
    Death
    Date Received
    July 7, 2017
    Report Date
    December 5, 2017
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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. 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 WITH UNKNOWN SERIAL NUMBER WAS NOT RETURNED TO HEARTWARE FOR EVALUATION. REVIEW OF THE MANUFACTURING DOCUMENTATION WAS NOT PERFORMED SINCE THE SERIAL NUMBER IS UNKNOWN. REVIEW OF CONTROLLER LOG FILES COULD NOT BE PERFORMED SINCE THE SERIAL/LOT NUMBER AS WELL AS THE PATIENT ID IS UNKNOWN. THERE IS NO EVIDENCE TO SUGGEST THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INVESTIGATION CONDUCTED, THERE IS NO EVIDENCE TO SUGGEST THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISE WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. REFERENCED ARTICLE: EURO INTERVENTION DOI: 10.4244/EIJV12I4A89 ARTICLE NAME: HOW SHOULD I TREAT A MITRAL PROSTHESIS RUPTURE AFTER LEFT VENTRICULAR ASSIST DEVICE IMPLANTATION? BY: GIANLUCA SANTISE1*, MD; SAVERIO NARDELLA1, MD; STEFANIA LEONETTI2, MD; DARIO BUIONI1, MD; BINDO MISSIROLI3, MD; EMANUELE DI MARZIO4, MD; DANIELE MASELLI1, MDX

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM THE MEDICAL JOURNAL, EURO INTERVENTIONS, PUBLISHED ON THE 20 OF JULY 2016 THAT THE PATIENT, WHICH WAS DIAGNOSED WITH MITRAL PROSTHESIS LEAFLET RUPTURE PROBABLY CAUSED BY LEFT VENTRICULAR VENT REMOVAL, WAS ADMITTED TO THE HOSPITAL WITH A DIAGNOSIS OF THREE-VESSEL CORONARY ARTERY DISEASE, LEFT VENTRICULAR DYSFUNCTION AND SEVERE FUNCTIONAL MITRAL REGURGITATION. THE PATIENT, AFTER PREPARATION WITH 48 HOURS OF LEVOSIMENDAN 0.05 ¿G·KG·MIN, UNDERWENT A MITRAL VALVE REPLACEMENT WITH THE MOSAIC® 29 MM BIO PROSTHESIS AND CORONARY ARTERY BYPASS GRAFT ON THE LEFT ANTERIOR DESCENDING ARTERY AND THE OBTUSE MARGINAL BRANCH, WITH A TOTAL AORTIC CROSS-CLAMP TIME OF 46 MINUTES. UNFORTUNATELY, DESPITE MAXIMAL INOTROPIC INFUSION AND INTRA-AORTIC BALLOON PUMP, THE PATIENT EXPERIENCED SEVERE BIVENTRICULAR FAILURE. THEREFORE, AFTER A FAILED ATTEMPT AT WEANING THE CARDIOPULMONARY BYPASS (CPB), THE PATIENT WAS ASSISTED WITH EXTRACORPOREAL MEMBRANE OXYGENATOR (ECMO) SUPPORT. THE AORTA AND RIGHT ATRIUM WERE CANNULATED AS IS THE ROUTINE APPROACH FOR POST-CARDIOTOMY SUPPORT. THEN, GIVEN THE SEVERE LEFT VENTRICULAR DYSFUNCTION, LEFT VENTRICULAR VENTING WAS ASSURED THROUGH THE LEFT ATRIUM. THE INTRA-AORTIC BALLOON PUMP WAS LEFT IN SITU TO ALLOW THE AORTIC VALVE TO OPEN. THE ECMO WAS BENEFICIAL AND FREE FROM COMPLICATIONS, LACTATES RECOVERED, THE RENAL FUNCTION WAS PRESERVED AND NO END-ORGAN DYSFUNCTION WAS OBSERVED. THEREFORE, AFTER SIX DAYS, GIVEN THE ABSENCE OF LEFT VENTRICLE RECOVERY, WE DECIDED TO UPGRADE THE CIRCULATORY SUPPORT TO A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE PATIENT WAS SENT TO THE OPERATING ROOM, THE PREVIOUS STERNOTOMY WAS REOPENED AND THE AORTA AND THE RIGHT ATRIUM WERE CANNULATED WITH NEW CANNULAE. CARDIOPULMONARY BYPASS WAS INSTITUTED WHILE THE ECMO WAS SUSPENDED AND THE PREVIOUS CANNULAE WERE REMOVED. KEEPING THE HEART BEATING, THE SEWING RING OF THE INFLOW CANNULA WAS SUTURED ONTO THE APEX OF THE HEART AND THE LVAD WAS PLACED. SUBSEQUENTLY, THE OUTFLOW GRAFT WAS SUTURED ONTO THE LATERAL WALL OF THE ASCENDING AORTA DURING PARTIAL AORTIC CLAMPING. THE PROCEDURE WAS STRAIGHTFORWARD WITHOUT COMPLICATIONS, AND THE CPB WAS WEANED WITH SATISFACTORY HEMODYNAMICS. SURPRISINGLY, THE INTRAOPERATIVE TRANSESOPHAGEAL ECHOCARDIOGRAM SHOWED SEVERE INTRAPROSTHETIC MITRAL REGURGITATION, PROBABLY CAUSED BY LEAFLET RUPTURE AFTER THE LEFT VENTRICULAR VENT. DESPITE LVAD REVOLUTIONS-PER-MINUTE OPTIMIZATION, THE MITRAL REGURGITATION REMAINED SEVERE AND THE PULMONARY PRESSURE WAS HIGH. THE PROSTHETIC REGURGITATION WAS CONSIDERED DETRIMENTAL FOR THE RIGHT VENTRICULAR FUNCTION; HOWEVER, AFTER A MULTIDISCIPLINARY DISCUSSION WITH THE ANESTHESIOLOGIST AND THE CARDIOLOGIST, THE TRADITIONAL SURGICAL PROSTHESIS REPLACEMENT WAS CONSIDERED A HIGH-RISK PROCEDURE. UNFORTUNATELY, THE PATIENT DIED A FEW DAYS LATER AFTER A SEVERE SEPTIC SHOCK WITH RIGHT VENTRICULAR FAILURE. NO ADDITIONAL INFORMATION AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM THE SITE THAT THE PATIENT DIED ON THE (B)(6) 2015. IT WAS STATED THAT THE CAUSE OF DEATH WAS STATED TO HAVE BEEN SEPSIS FROM THE LUNGS. IT WAS STATED THAT THE DEATH WAS NOT A DEVICE ISSUE OR MALFUNCTION. IT WAS FURTHER STATED THAT THE SOURCE OF THE INFECTION WAS NOT DEVICE OR PROCEDURE RELATED. THE SITE INDICATED THAT THE PUMP REMAINED IMPLANTED AND WOULD NOT BE RETURNED. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475502 HEARTWARE® VENTRICULAR ASSIST SYSTEM - PUMP CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC 1104

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death