BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 5820151 · Received July 25, 2016

    Report

    Report Number
    2916596-2016-01407
    Event Type
    Injury
    Date Received
    July 25, 2016
    Date of Event
    June 26, 2016
    Report Date
    June 27, 2016
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: IT WAS NOTED THAT THE REFERENCED MEDWATCH MFR REPORT NUMBER WAS INADVERTENTLY OMITTED FROM THE INITIAL MEDWATCH REPORT. THE REPORT FOR THE GI BLEEDING WAS COVERED UNDER MEDWATCH MFR # 2916596-2016-01412.

    Additional Manufacturer Narrative · 1

    THE PATIENT¿S AGE AND WEIGHT WERE NOT PROVIDED. THE REFERENCED HISTORY OF GI BLEEDING WAS REPORTED UNDER MEDWATCH MFR REPORT #XXXXXXXXX. THE SERIAL NUMBER OF THE DEVICE WAS NOT PROVIDED, THEREFORE THE MANUFACTURE DATE, APPROXIMATE AGE OF DEVICE, AND DEVICE UNIQUE IDENTIFIER (UDI) ARE UNKNOWN. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS. IT HAS NOT YET BEEN RECEIVED. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION. DEVICE UNIQUE IDENTIFIER (UDI) # (B)(4). APPROXIMATE AGE OF DEVICE ¿ 4 MONTHS. DEVICE EVALUATION: THE REPORTED PUMP POWER ELEVATIONS, PUMP STOPPAGES, AND LOW SPEED EVENTS WAS CONFIRMED THROUGH THE ANALYSIS OF THE SUBMITTED SYSTEM CONTROLLER LOG FILE; HOWEVER, A SPECIFIC CAUSE FOR THE EVENTS COULD NOT BE DETERMINED. THE PUMP WAS RETURNED ASSEMBLED WITH THE DRIVELINE CUT APPROXIMATELY 4 INCHES FROM THE PUMP HOUSING AND APPROXIMATELY 6 INCHES OF THE SEVERED DRIVELINE WAS RETURNED. UPON DISASSEMBLY OF THE RETURNED PUMP, EXAMINATION OF THE PUMP BLOOD CONTACTING SURFACES REVEALED NO ADHERED THROMBUS FORMATIONS OR DEPOSITIONS. EXAMINATION OF THE PUMP BEARINGS, ROTOR, AND BLOOD CONTACTING SURFACES UNDER A MICROSCOPE, REVEALED NO ABNORMALITIES. CONTINUITY AND HIGH POTENTIAL TESTING WAS PERFORMED ON BOTH PORTIONS OF THE RETURNED DRIVELINE AND DID NOT IDENTIFY ANY BREACHES TO THE INSULATION OF ANY OF THE WIRES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENTS. THE PUMP UNDERWENT CLEANING, REASSEMBLY, AND FUNCTIONAL TESTING UNDER LOADED CONDITIONS USING A MOCK CIRCULATORY LOOP. THE RETRIEVED DATA REVEALED NORMAL PUMP POWER CONSUMPTION COMPARABLE TO THE PUMP POWER CONSUMPTION RECORDED DURING THE MANUFACTURING PROCESS AND THE PUMP OPERATED AS INTENDED. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED THAT ON (B)(6) 2016, THE PATIENT NOTICED A SUSTAINED RISE IN ESTIMATED FLOWS AND PUMP POWERS. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND THE LVAD PARAMETERS ROSE HIGHER. THE PATIENT HAD REPORTEDLY BEEN OFF ANTICOAGULATION FOR A SEVERAL WEEKS DUE TO A SEVERE GI BLEEDING HISTORY. ON ADMISSION, THE PATIENT'S LACTATE DEHYDROGENASE (LDH) LEVEL WAS 214 U/L. A SYSTEM CONTROLLER LOG FILE REVIEWED BY THE MANUFACTURER'S TECHNICAL SERVICES REPRESENTATIVE SHOWED AN ELEVATION IN PUMP POWER AND ESTIMATED FLOW WITH SOME POWER SPIKES OVER 10 WATTS THAT WERE ASSOCIATED WITH PULSATILITY INDEX (PI) EVENTS. STARTING ON (B)(6) 2016, THERE WAS AN INCREASE IN PI EVENTS THAT SEEMED TO CORRELATE WITH THE ELEVATIONS IN PUMP POWER AND ESTIMATED FLOW. ON (B)(6) 2016, THE VAD COORDINATOR REPORTED THAT A PUMP STOP ALARM OCCURRED. THE SYSTEM CONTROLLER LOG FILE REVIEWED BY TECHNICAL SERVICES SHOWED THAT THE PUMP WAS LABORING TO MAINTAIN THE SET SPEED ON (B)(6) 2016 CAUSING MULTIPLE LOW SPEED ALARMS AS WELL AS TWO PUMP STOPPAGES WHILE THE PATIENT WAS CONNECTED TO THE POWER MODULE. THE DURATION OF THE EVENT WAS APPROXIMATELY 6 SECONDS. PER THE DOCTOR, THE PATIENT WAS CAREFUL ABOUT THE DRIVELINE AND HAD NOT HAD ANY TRAUMA OR OTHER STRESS AFFECTING IT TO THE BEST OF THEIR KNOWLEDGE. THE PUMP WAS EXCHANGED ON (B)(6) 2016 DUE TO THE DOCTOR'S CONCERN ABOUT POSSIBLE THROMBUS ALONG WITH THE TRANSIENT PUMP STOPPAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473171 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R