BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 4950879 · Received July 29, 2015

    Report

    Report Number
    3007042319-2015-01712
    Event Type
    Death
    Date Received
    July 29, 2015
    Date of Event
    July 20, 2015
    Report Date
    July 21, 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

    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. REVIEW OF LOG FILES ON (B)(6) 2015 BY THE MANUFACTURER INDICATED 14 LOW FLOW ALARMS SINCE (B)(6) 2015 AND A RISE IN POWER CONSUMPTION LOGGED IN STARTING (B)(6) 2015 WITH A PEAK OUTSIDE OF NORMAL POWER CONSUMPTION. IMPLANTATION OF A VENTRICULAR ASSIST DEVICE (VAD) IS AN INVASIVE PROCEDURE REQUIRING GENERAL ANESTHESIA, A MEDIAN STERNOTOMY, A VENTILATOR AND CARDIOPULMONARY BYPASS. THESE SURGICAL PROCEDURES AND THE USE OF THE DEVICE ARE ASSOCIATED WITH NUMEROUS RISKS INCLUDING BLEEDING, HEMOLYSIS, DEVICE THROMBOSIS, MULTI-ORGAN FAILURE AND DEATH AS OUTLINED IN THE INSTRUCTIONS FOR USE (IFU). OBSTRUCTION OF THE INFLOW CANNULA BY THE INTRAVENTRICULAR SEPTUM IS A KNOWN POTENTIAL OCCURRENCE WITH THE IFU OUTLINING POTENTIAL CAUSES AND PUMP PLACEMENT GUIDELINES; AS REPORTED THE PATIENT'S PRE-EXISTING RIGHT HEART FAILURE APPEARS TO HAVE CONTRIBUTED TO THIS EVENT. HIGH WATTS ALARMS, 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. HEMOLYSIS MAY BE DUE NON-DEVICE RELATED CAUSES OR SHEARING WITHIN THE PUMP, AND MAY LEAD TO THE DISRUPTION OF THE INTEGRITY OF THE ERYTHROCYTE MEMBRANE. THE INSTRUCTIONS FOR USE 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). WITH REVIEW OF THE AVAILABLE INFORMATION THERE IS NO INDICATION OF ANY DEVICE MANUFACTURING OR PERFORMANCE ISSUES RELATED TO THE EVENTS WITH THIS PATIENT'S PREOPERATIVE CONDITION AND CLINICAL FACTORS APPEARING TO HAVE CONTRIBUTED. MISSING INFORMATION FROM THIS REPORT IS IDENTIFIED AS A BLANK, UNKNOWN AND AS NO INFORMATION (NI); THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION. THE COMPANY IS SEEKING THIS INFORMATION THROUGH THE EVENT INVESTIGATION. THIS IS ONE OF TWO REPORTS (3007042319-2015-01711 AND 3007042319-2015-01712) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT.

    Additional Manufacturer Narrative · 1

    NO DEVICE MALFUNCTION WAS REPORTED AGAINST (B)(4); THEREFORE, THE PURPOSE OF THIS ANALYSIS IS SOLELY TO EVALUATE THE PERFORMANCE OF THE RETURNED DEVICE AGAINST CURRENT MANUFACTURING/DESIGN SPECIFICATIONS AND/OR TO IDENTIFY ANY ANOMALIES INTRODUCED DURING USE THAT MAY HAVE PREVENTED THE PUMP FROM PERFORMING AS INTENDED. THE DEVICE PASSED VISUAL EXAMINATION, FUNCTIONAL TESTING AND DIMENSIONAL VERIFICATION. THERE WERE NO GROSS SURFACE ABRASIONS ON THE PUMP AND IMPELLER SURFACES. INDEPENDENT PATHOLOGY REPORT DID NOT REVEAL EVIDENCE OF THROMBUS WITHIN THE PUMP. THERE IS NO EVIDENCE TO SUGGEST THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. NO AUTOPSY WAS PERFORMED BUT THE PUMPS WERE RETURNED FOR EVALUATION. CLINICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT AND PATIENT OUTCOME INCLUDE THE PATIENT'S PAST MEDICAL HISTORY OF BIVENTRICULAR FAILURE, AND ISSUES WITH PROPER INFLOW CANNULA POSITIONING AS A RESULT OF THE SEPTAL WALL BEING FLEXED OVER TO THE LVAD INFLOW CANNULA. THIS RESULTED IN VENTRICULAR FILLING ISSUES REQUIRING PLACEMENT OF THE RVAD. THE PATIENT'S POST-OPERATIVE COURSE WAS FURTHER COMPLICATED BY DISSEMINATED INTRAVASCULAR COAGULATION (DIC) REQUIRING RE-THORACOTOMY, THROMBUS, AND EVENTUALLY, MULTI-ORGAN FAILURE. WITH REVIEW OF THE AVAILABLE INFORMATION THERE IS NO INDICATION OF ANY DEVICE MANUFACTURING OR PERFORMANCE ISSUES RELATED TO THE REPORTED EVENT. THIS PATIENT'S PREOPERATIVE CONDITION AND COMPLICATIONS POST IMPLANT PROCEDURE MAY HAVE CONTRIBUTED. THE MOST LIKELY ROOT CAUSE OF THE HIGH POWER EVENT REPORTED FOR (B)(4) CAN BE ATTRIBUTED TO THROMBUS FORMATION WITHIN THE PUMP. THE MOST LIKELY ROOT CAUSE OF THE PATIENT OUTCOME MAY BE ATTRIBUTED TO THE PATIENT'S HISTORY OF BIVENTRICULAR FAILURE, THE IMPLANT PROCEDURE, THROMBUS FORMATION WITHIN IN THE PUMP AND COMPLICATIONS EXPERIENCED DURING THE PATIENT'S POST-OPERATIVE PERIOD. 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. THIS IS ONE OF TWO REPORTS (3007042319-2015-01711 AND 3007042319-2015-01712) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT.

    Description of Event or Problem · 1

    THE PERFUSIONIST AT THE IMPLANT SITE IN (B)(6) REPORTED THAT THE LVAD WAS IMPLANTED ON (B)(6) 2015 IN THIS PATIENT WHO HAD BIVENTRICULAR FAILURE. DUE TO THE STATUS OF VENTRICULAR FILLING, UPON STARTING THE LVAD PUMP, THE SEPTAL WALL FLEXED OVER TO THE LVAD INFLOW CANNULA. TEMPORARY RIGHT VENTRICULAR ASSIST DEVICE (RVAD) WAS REQUIRED DUE TO CONTINUED RIGHT HEART FAILURE. BECAUSE OF MASSIVE BLEEDING DUE TO DISSEMINATED INTRAVASCULAR COAGULATION (DIC) RE-THORACOTOMY WAS REQUIRED. ON (B)(6) 2015 THERE WAS HEMOLYSIS AND THE PUMP POWER CONSUMPTION INCREASED. THE PATIENT WAS PUT ON A VENOARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION (VA ECMO) WITH THE LVAD IN PLACE AND THE LVAD PUMP WAS EXCHANGED ON (B)(6) 2015 WITH TEMPORARY RVAD STILL BEING REQUIRED. MULTI ORGAN FAILURE THEN DEVELOPED AND THE DECISION WAS MADE TO TURN OFF THE LVAD AND RVAD ON (B)(6) 2013 AND THE PATIENT EXPIRED. THIS IS REPORT 2 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492970 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Death