BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS, EUROPE

    MDR report key: 6082920 · Received November 7, 2016

    Report

    Report Number
    2916596-2016-02172
    Event Type
    Death
    Date Received
    November 7, 2016
    Date of Event
    October 9, 2016
    Report Date
    March 28, 2018
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE UNIQUE IDENTIFIER (UDI) ¿ DEVICE WAS MANUFACTURED PRIOR TO THE UDI LABELING IMPLEMENTATION. APPROXIMATE AGE OF DEVICE ¿ 4 YEARS, 2 MONTHS. THE EVENT OCCURRED AT (B)(6). THE DEVICE WAS NOT EXPLANTED FROM THE PATIENT AND THEREFORE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE PUMP AND ITS DRIVELINE WERE NOT AVAILABLE FOR EVALUATION; THEREFORE, THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, A REVIEW OF THE SUBMITTED SYSTEM CONTROLLER LOG FILES SHOWED MULTIPLE LOW SPEED EVENTS AND PUMP STOPPAGES ASSOCIATED WITH LOW SPEED ADVISORY, LOW SPEED HAZARD AND LOW FLOW HAZARD ALARMS AS WELL AS SIGNIFICANT ELEVATIONS IN PUMP POWER UP TO 39 WATTS. BASED ON THE MANUFACTURER'S PREVIOUS COMPLAINT EXPERIENCE, THESE ATYPICAL EVENTS CAPTURED IN THE LOG FILES APPEAR CONSISTENT WITH POTENTIAL PERCUTANEOUS LEAD WIRE DAMAGE. THE INFORMATION CONTAINED IN THE LOG FILES INDICATE THAT THE INTERRUPTIONS IN PUMP FUNCTION OCCURRED WHILE THE SYSTEM WAS OPERATING ON BATTERY POWER, SUGGESTING DAMAGE TO AT LEAST TWO WIRES FROM DIFFERENT PHASES OF THE THREE-PHASE MOTOR. 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.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: A DIRECT CORRELATION BETWEEN THE DEVICE AND THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. REVIEW OF THE SUBMITTED SYSTEM CONTROLLER LOG FILES CONFIRMED THE REPORTED PUMP STOPPAGES; HOWEVER, A SPECIFIC CAUSE FOR THE ABNORMAL PUMP OPERATION COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. A REVIEW OF THE SUBMITTED SYSTEM CONTROLLER LOG FILES REVEALED MULTIPLE LOW SPEED EVENTS AND PUMP STOPPAGES ASSOCIATED WITH LOW SPEED ADVISORY, LOW SPEED HAZARD AND SCATTERED LOW FLOW HAZARD ALARMS AS WELL AS SIGNIFICANT ELEVATIONS IN PUMP POWER. BASED ON THE MANUFACTURER'S PREVIOUS COMPLAINT EXPERIENCE, THESE ATYPICAL EVENTS CAPTURED IN THE LOG FILES APPEARED CONSISTENT WITH POTENTIAL DRIVELINE (PERCUTANEOUS LEAD) WIRE DAMAGE. THE INTERRUPTIONS IN PUMP FUNCTION CAPTURED IN THE LOG FILES OCCURRED WHILE THE SYSTEM WAS OPERATING ON BATTERIES, SUGGESTING DAMAGE TO AT LEAST TWO WIRES FROM DIFFERENT PHASES OF THE THREE-PHASE MOTOR. HOWEVER, THE SUSPECTED DRIVELINE WIRE DAMAGE WAS NOT CONFIRMED DURING THE EVALUATION OF THE REPLACED PORTION OF THE DRIVELINE. APPROXIMATELY 20 INCHES OF THE EXTERNAL PORTION/DISTAL END OF THE DRIVELINE WAS RETURNED FOR EVALUATION. ELECTRICAL CONTINUITY TESTING OF THE DISTAL END OF THE DRIVELINE REVEALED NO DISCONTINUITIES OR SHORTS, EVEN WITH MANIPULATION OF THE LEAD. THE MAJORITY OF THE OUTER SILICONE SLEEVE HAD BEEN REMOVED FROM THE LEAD PRIOR TO RECEIPT, WHICH SHOWED EVIDENCE OF COSMETIC TEARS BENEATH THE EXTENSIVE RESCUE TAPE REPAIRS. NO DAMAGE TO THE CLEAR BIONATE LAYER WAS NOTED. MODERATE BREAKDOWN OF THE METAL BRAIDED SHIELD WAS OBSERVED ALONG THE LENGTH OF THE RETURNED PERC LEAD SEGMENT, WHICH APPEARED CONSISTENT WITH OVER 4 YEARS OF USE. HOWEVER, THE UNDERLYING WIRES APPEARED OVERALL UNREMARKABLE WITH NO EVIDENCE OF TWISTING, KINKING, OR SEVERE INSULATION ABRASION. MICROSCOPIC INSPECTION OF THE UNDERLYING WIRES REVEALED NO AREAS OF COMPROMISED WIRE INSULATION OR DAMAGE TO THE INNER CONDUCTORS ALONG THE LENGTH OF THE DRIVELINE SEGMENT. THE RETURNED PORTION OF THE DRIVELINE WAS SUSPENDED IN A SALINE BATH FOR HIGH-POTENTIAL TESTING TO CHECK FOR CURRENT LEAKAGE THROUGH THE WIRE INSULATION, AND NO AREAS OF COMPROMISED WIRE INSULATION WERE IDENTIFIED. 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) (B)(6) 2012. IT WAS REPORTED THAT AFTER OVER FOUR YEARS OF SUPPORT ON (B)(6) 2016, THE PATIENT'S SYSTEM CONTROLLER SOUNDED WITH AN ALARM THAT WAS DESCRIBED AS A POWER CABLE DISCONNECTED ALARM, FOLLOWED BY A CONTINUOUS BEEPING TONE. THE PATIENT EXCHANGED THE SYSTEM CONTROLLER AT HOME. THE PUMP PARAMETERS WERE REPORTEDLY WITHIN NORMAL RANGE. THE NEXT MORNING, ON (B)(6) 2016, THE SYSTEM CONTROLLER SOUNDED WITH A SIMILAR ALARM AND THE PATIENT WAS ADVISED TO GO TO THE HOSPITAL. UPON ARRIVAL OF AN AMBULANCE, A PUMP STOPPAGE OCCURRED. THE EMERGENCY PHYSICIAN PLACED THE PATIENT ON VENO-ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION (VA-ECMO) SUPPORT IN THE PATIENT'S HOME. THE PATIENT WAS STABILIZED AND THEN URGENTLY TRANSPORTED TO THE IMPLANTING HOSPITAL. IN THE EMERGENCY ROOM, IT WAS CONFIRMED THAT THE PUMP WAS STOPPED. THE OUTER PART OF THE DRIVELINE REPORTEDLY HAD STRONG SIGNS OF WEAR, AND A REPLACEMENT OF THE DISTAL END PERCUTANEOUS LEAD (DRIVELINE) WAS PERFORMED. THE PUMP WAS NOT ABLE TO BE RESTARTED. IT WAS REPORTED THAT THE PATIENT EXPIRED WHILE ON EXTRACORPOREAL CIRCULATORY LIFE SUPPORT (ECLS) ON (B)(6) 2016, AND THAT PERMISSION TO EXPLANT THE PUMP WAS NOT RECEIVED. THE PORTION OF THE DRIVELINE THAT WAS REMOVED WAS EXAMINED BY HOSPITAL PERSONNEL AT THE USER FACILITY. THE EXAMINATION REPORTEDLY SHOWED NO ELECTRICAL FAULT. ELECTRICAL CONTINUITY TESTING REVEALED THAT ALL WIRES WERE INTACT AND A SHORT TO SHIELD CONDITION COULD NOT BE DETECTED. AN EXAMINATION OF BOTH OF THE PATIENT'S USED SYSTEM CONTROLLERS SHOWED THAT THEY DID NOT FUNCTION AND COULD NOT START A PUMP. A CONTROL TEST CONDUCTED WITH A FUNCTIONING SYSTEM CONTROLLER SHOWED THAT A SIMILAR FAULT ALARM OCCURRED WHEN IT WAS CONNECTED TO A DRIVELINE WITH MULTIPLE SHORTED MOTOR WIRES. THE USER FACILITY CLINICIANS SUSPECTED A SHORT CIRCUIT BETWEEN THE MOTOR PHASES OF THE DRIVELINE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733496 HEARTMATE II LVAS, EUROPE LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Death| H| R