BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 3795939 · Received April 25, 2014

    Report

    Report Number
    2916596-2014-00652
    Event Type
    Death
    Date Received
    April 25, 2014
    Date of Event
    March 26, 2014
    Report Date
    March 26, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALAUTION AND IS CURRENTLY BEING ANALZYED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    NO DEVICE RELATED ISSUES WERE IDENTIFIED DURING THE EVALUATION OF THE VAD. ACCORDING TO INFORMATION PROVIDED TO THE MANUFACTURER, THE PATIENT EXPIRED DUE TO A RETROPERITONEAL BLEED WHICH RESULTED FROM HIGH LEVELS OF ANTICOAGULATION. THE PUMP WAS RETURNED ASSEMBLED WITH THE PERCUTANEOUS LEAD SEVERED APPROXIMATELY 5¿ FROM THE PUMP HOUSING AND THE SEVERED PORTION OF THE LEAD WAS NOT RETURNED. THE SEALED INFLOW CONDUIT WAS RETURNED DETACHED FROM THE INLET PORT. THE SEALED OUTFLOW GRAFT, BEND RELIEF AND BEND RELIEF COLLAR WERE NOT RETURNED. EXAMINATION OF THE INFLOW CONDUIT SHOWED NO EVIDENCE OF ADHERED DEPOSITION OR THROMBUS FORMATION. EXAMINATION OF THE RETURNED PUMP DID NOT REVEAL ANY ANOMALIES OR DEPOSITIONS ON THE BEARINGS OR ANY OF THE BLOOD-CONTACTING SURFACES. THE PUMP BEARINGS, ROTOR AND BLOOD CONTACTING SURFACES WERE EXAMINED UNDER A MICROSCOPE AND NO ANOMALIES WERE OBSERVED THAT WOULD HAVE CONTRIBUTED TO A FUNCTIONAL ISSUE. THE PUMP WAS CLEANED, REASSEMBLED, AND FUNCTIONALLY TESTED UNDER NORMAL OPERATING CONDITIONS ACCORDING TO OUR MANUFACTURING PROCEDURE USING A MOCK CIRCULATORY LOOP. THE DATA RETRIEVED FROM OUR TESTING REVEALED NORMAL PUMP POWER CONSUMPTION COMPARABLE TO THE PUMP POWER CONSUMPTION RECORDED DURING THE MANUFACTURING PROCESS AND THE PUMP OPERATED AS INTENDED. (B)(4). A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PATIENT EXPERIENCED SEVERAL ALARMS. UPON INTERROGATION OF THE HISTORY SCREEN, THE ALARMS READ PI EVENT, LOW SPEED ADVISORY AND PUMP OFF. THE CLINICAL SPECIALIST DISCUSSED SEVERAL SCENARIOS INCLUDING DRIVELINE FRACTURE, CONTROLLER ISSUES/CHANGE, BIOMATTER IN THE PUMP, AND THE DIFFERENCE BETWEEN POWER RELATED ISSUES AND DRIVELINE/PUMP RELATED ISSUES. THE VAD COORDINATOR STATED THAT SHE WOULD CALL WITH ANY ADDITIONAL INFORMATION OVERNIGHT. ALSO DISCUSSED PERFORMING X-RAYS OF THE DRIVELINE TO FULLY RULE OUT DRIVELINE WIRE ISSUES. LOCAL CLINICAL WILL FOLLOW-UP WITH ACCOUNT TO DETERMINE FUTURE COURSE OF ACTION. ON (B)(6) 2014 NO MORE ISSUES WITH PATIENT OR PUMP THUS FAR. LDH 500'S. EVENT OCCURRED WHEN PATIENT WAS ON BEDSIDE COMMODE, BENT OVER. PATIENT KNOWN TO HAVE SEVERE KYPHOSIS. PATIENT NOW HAS INR 2.7, ON HEPARIN GTT WITH PTT>200, INTEGRILIN, PERSANTINE 75MG TWICE A DAY (BID), AND ASA 325. THE VAD COORDINATOR WILL ATTEMPT TO SEND LOG FILES IF SHE CAN UNENCRYPT THE DATA. THE VAD COORDINATOR ENCOURAGED TO CALL WITH ANY CHANGE IN PATIENT STATUS. ON (B)(6) 2014 FOLLOW-UP WHILE AT CENTER TODAY WITH THE VAD COORDINATOR. THE VAD COORDINATOR REPORTS ANOTHER PUMP STOP ON (B)(6) 2014 AT APPROX 1400. THE PATIENT WAS SITTING IN A CHAIR, BUTTONING VEST WHEN THE PUMP STOPPAGE OCCURRED. PUMP RESTARTED ON ITS OWN. ASYMPTOMATIC WITH EVENT. LDH HAS BEEN TRENDING UP ((B)(6)) AND NOW "PLATEAUED". BACKUP CONTROLLER CHANGED OUT AS PART OF TROUBLESHOOTING - PC 15037-E REMOVED FROM USE. THE VAD COORDINATOR REQUESTING ANALYSIS BUT WOULD LIKE CONTROLLER BACK FOR DEMO. LOG FILES FROM (B)(6) SENT. THE VAD COORDINATOR IS UNABLE TO REPRODUCE ALARM BY MANIPULATING THE DRIVELINE, PALPATING CHEST, OR CHANGING PATIENT POSITION. X-RAY OF DRIVELINE REVEALED NO APPARENT FRACTURES IN DRIVELINE. THE PATIENT IS ON HEPARIN AND INTEGRILIN IV GTT (AS WELL AS ASA AND PRESANTINE PO). MAY CONSIDER USING PRASUGREL (EFFIENT) FURIA. FIVE HUNDRED CC IVF ADMINISTERED YESTERDAY WITH MAINTENANCE IVF AT 80 CC/HR. ECHO DONE TODAY AT BEDSIDE. SPEED 9000, FLOW 7.4, PI 5.2, PP 5.9, LVEDD 6.4CM AV OPENING EVERY 4TH BEAT, RV "GOOD". INFLOW VELOCITY 80-100. WHEN SPEED INCREASED TO 9600, FLOW 7.0, PI 5.2, 99 7.3, LVEDD DECREASED TO 5.5CM, AV OPERATING INTERMITTENTLY. SPEED BACK TO 9000. CONTINUE CLOSE FOLLOW-UP, PATIENT REFUSING ANY FURTHER SURGICAL INTERVENTION AT THIS POINT, MEDICAL MGMT. THE EVENT LOG SAVED ON (B)(6) 2014 AT 16:33 CONFIRMS THE PUMP STOP EVENT. THESE EVENTS OCCURRED WHILE THE PATIENT WAS CONNECTED TO THE PATIENT CABLE. THE EVENT LOG CONTAINED ABOUT 4 DAYS OF DATA WITH THE DATA LOGGER ENABLED TO RECORD AT 30 MIN INTERVALS. THERE WAS A BRIEF PERIOD WHEN THE EVENT LOG WAS SET TO RECORD AT 2 HOUR INTERVALS ON (B)(6) 2014. THE LAST EVENT IN THE EVENT LOG IS A DATA EVENT DATED (B)(6) 2014 AT 16:27. THE SECOND EVENT LOG SENT CONTAINS A PATIENT ID OF (B)(6) AND WAS SAVED ON (B)(6) 2014 AT 13:37. THE FIRST EVENT WHEN THE EVENT LOG INDICATES THE DRIVELINE WAS CONNECTED HAS A TIME STAMP OF (B)(6) 2014 AT 15:43. UNFORTUNATELY FROM REVIEWING THE EVENT LOGS, WE ARE NOT ABLE TO EXPLAIN WHY THE PUMP STOP EVENTS OCCURRED IN THE EVENT LOG HISTORY. WHEN SPEAKING WITH THE CLINICAL SPECIALIST AFTER THE EVENT LOG ANALYSIS WAS SENT, ONE CONTROLLER MAY NOT HAVE BEEN CONFIGURED FOR DAYLIGHT SAVINGS TIME, HENCE THE OVER LAPPING TIME IN THE TWO EVENT LOG FILES. IF YOU HAVE NOT ALREADY DONE SO, IT IS RECOMMENDED TO EXCHANGE THE POCKET CONTROLLER. NO FURTHER PUMP STOPPAGES AS OF (B)(6) 2014 AT 1130. LDH DECREASING. THE PATIENT EXPERIENCED LARGE RETROPERITONEAL BLEED, OFF ALL ANTICOAGULATION AT THE MOMENT. CONTINUE TO MONITOR, MEDICAL MGMT, POSSIBLE DNR STATUS PENDING PER VAD COORDINATOR. PER THE VAD COORDINATOR, THE FAMILY WITHDREW CARE ON PATIENT (B)(6) 2014 AND PATIENT EXPIRED THE SAME DAY. SINCE RETROPERITONEAL BLEED OCCURRED, PATIENT IS IN EXCRUCIATING PAIN. HEAVILY SEDATED TO CONTROL PAIN. PATIENT DID NOT WISH TO HAVE ANY FURTHER SURGICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250444 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 106015 136666

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death| R