BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, JP

    MDR report key: 10359379 · Received August 3, 2020

    Report

    Report Number
    2916596-2020-03580
    Event Type
    Death
    Date Received
    August 3, 2020
    Date of Event
    July 11, 2020
    Report Date
    January 5, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D4, D10, H3, H4: ADDITIONAL INFORMATION MANUFACTURER'S INVESTIGATION CONCLUSION: INCIDENTAL FINDINGS: TEARS TO THE OUTER SILICONE JACKET WERE OBSERVED ON THE DISTAL PORTION OF THE DRIVELINE. A SPECIFIC CAUSE FOR THIS SUPERFICIAL DAMAGE COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. UPON DISASSEMBLY OF THE PUMP, A SMALL CRACK WAS OBSERVED ON THE PROTECTIVE WRAP SURROUNDING THE DRIVELINE LEADS TO THE MOTOR CAPSULE; HOWEVER, THE ELECTRICAL LEADS APPEARED FREE OF DAMAGE. ADDITIONALLY, CORROSION WAS NOTED SURROUNDING ONE OF THE ELECTRICAL PINS ON THE MOTOR CAPSULE. THIS ISSUE WAS PREVIOUSLY INVESTIGATED AND IT WAS DETERMINED THAT THE CORROSION WAS AN INCIDENTAL FINDING THAT IS NOT MANUFACTURING- OR DESIGN-RELATED. A SPECIFIC CAUSE FOR THE CORROSION COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, THERE IS NO SIGNIFICANT EVIDENCE THAT IT IS CHEMICALLY INDUCED. THIS OBSERVATION OF IS DETERMINED TO BE AN INCIDENTAL FINDING, AND NO FURTHER ACTION IS REQUIRED. ADDITIONALLY, REVIEW OF THE SUBMITTED LOG FILES FOUND INTERMITTENT LOW FLOW HAZARD ALARMS WHILE THE PUMP SPEED WAS ABOVE THE LOW SPEED LIMIT. A SPECIFIC CAUSE FOR THESE EVENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE EVALUATION OF THE RETURNED PUMP CONFIRMED WIRE DAMAGE ON THE INTERNAL PORTION OF DRIVELINE THAT WOULD HAVE CONTRIBUTED TO THE LOW SPEED EVENTS, PUMP DISCONNECTED ALARMS, AND PUMP STOPS THAT WERE OBSERVED IN THE SUBMITTED LOG FILES, AS WELL AS THE SUBMITTED PHOTO OF THE SYSTEM MONITOR SCREEN. ADDITIONALLY, THIS WIRE DAMAGE WOULD HAVE CAUSED THE COMPROMISED COMPONENT IN THE PRIMARY DRIVE CIRCUIT ON THE MAIN PRINTED CIRCUIT BOARD (PCB) OF THE RETURNED SYSTEM CONTROLLER, SERIAL NUMBER(B)(6) (REPORTED AND INVESTIGATED UNDER MFR # 2916596-2020-03679). A DIRECT CORRELATION BETWEEN THE REPORTED VENTRICULAR FIBRILLATION, PATIENT OUTCOME, AND HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (HMII LVAS), SERIAL NUMBER (B)(6) , COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. THE RETURNED CONTROLLER WAS CONNECTED TO A TEST POWER MODULE/SYSTEM MONITOR AND A TEST PUMP. THE CONTROLLER WAS UNABLE TO OPERATE THE TEST PUMP IN PRIMARY MODE, AND THE SYSTEM MONITOR INDICATED THAT THE PUMP WAS NOT CONNECTED. THE CONTROLLER WAS MANUALLY PUT INTO BACKUP MODE AND THE SYSTEM INITIATED OPERATION AT THE SET SPEED WITH A REPLACE SYSTEM CONTROLLER ALARM ACTIVE. THE CONTROLLER SUCCESSFULLY OPERATED THE TEST PUMP AT THE SET SPEED FOR AN EXTENDED PERIOD OF TIME WHILE IN BACKUP MODE. FURTHER EVALUATION OF THE CONTROLLER REVEALED A COMPROMISED COMPONENT IN THE PRIMARY DRIVE CIRCUIT ON THE PCB. THE COMPROMISED COMPONENT WAS REPLACED AND THE CONTROLLER SUCCESSFULLY OPERATED A TEST PUMP AT THE SET SPEED FOR AN EXTENDED PERIOD OF TIME WITHOUT ANY ISSUES OR ATYPICAL ALARMS PRODUCED. VAD-14194 WAS RETURNED ASSEMBLED WITH THE DRIVELINE (DL) INTACT. EXAMINATION OF THE BLOOD-CONTACTING SURFACES OF THE PUMP REVEALED NO EVIDENCE OF DEVELOPED DEPOSITIONS OR THROMBUS FORMATIONS. THE DRIVELINE PASSED ELECTRICAL CONTINUITY TESTING. VISUAL EXAMINATION OF THE WIRES OF THE DRIVELINE FOUND BREACHES TO THE INSULATION OF RED, BROWN, AND YELLOW WIRES, APPROXIMATELY 3¿ FROM THE PUMP HOUSING. THE YELLOW WIRE REDUNDANTLY SUPPORTS MOTOR PHASE 1, THE BROWN WIRE REDUNDANTLY SUPPORTS MOTOR PHASE 2, AND THE RED WIRE REDUNDANTLY SUPPORTS MOTOR PHASE 3. THE OBSERVED WIRE DAMAGE APPEARED TO BE THE RESULT OF REPETITIVE FLEXING. THE REMAINDER OF THE WIRES OF THE DRIVELINE WERE EXAMINED UNDER A MICROSCOPE AND NO ADDITIONAL AREAS OF WIRE INSULATION BREAKDOWN WERE OBSERVED. THE PUMP STOPPAGES, DRIVELINE DISCONNECT ALARMS, AND HAZARD ALARMS THAT WERE CONFIRMED THROUGH THE ANALYSIS OF THE SUBMITTED LOG FILES COULD HAVE RESULTED FROM A SHORT TO GROUND IF THE EXPOSED CONDUCTORS FROM ANY WIRE MADE CONTACT WITH THE BRAIDED SHIELD ON EITHER THE POWER MODULE OR MOBILE POWER UNIT. A PHASE-TO-PHASE SHORT ALSO COULD HAVE OCCURRED IF THE EXPOSED CONDUCTORS FROM TWO (OR ALL) PHASES¿ WIRES MADE DIRECT CONTACT WITH EACH OTHER OR SIMULTANEOUS CONTACT WITH THE BRAIDED SHIELD WHILE THE PATIENT WAS SUPPORTED BY BATTERIES. ADDITIONALLY, THIS WIRE DAMAGE WOULD HAVE CAUSED THE COMPROMISED COMPONENT IN THE PCB OF THE RETURNED SYSTEM CONTROLLER, SERIAL NUMBER EPC-40630 (REPORTED AND INVESTIGATED UNDER MFR # 2916596-2020-03679). THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR VAD-14194 WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE IMPLANT KIT WAS SHIPPED ON 05DEC2013. THE HEARTMATE II LEFT VENTRICULAR ASSIST (HMII LVAS) INSTRUCTIONS FOR USE (IFU), REV. B, IS CURRENTLY AVAILABLE. SECTION 5.0 OF THIS IFU LISTS CARDIAC ARRHYTHMIA AND DEATH AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HMII LVAS. SECTION 13.2.1 OF THIS IFU TITLED "PUMP FLOW", OUTLINES HOW PUMP FLOW IS ESTIMATED BASED ON PUMP POWER. SECTION 13.4 DESCRIBES ALL ALARM CONDITIONS, INCLUDING PUMP DISCONNECTED, LOW SPEED OPERATION, LOW FLOW HAZARD, AND PUMP OFF ALARMS. SECTION 17.1 OUTLINES PUMP PARAMETERS AND THAT PUMP PERFORMANCE IS SENSITIVE TO CHANGES IN SYSTEMIC VASCULAR RESISTANCE AND LEFT VENTRICULAR FILLING. THIS DOCUMENT ALSO CONTAINS INFORMATION REGARDING CARE FOR THE PERCUTANEOUS LEAD. THE HMII LVAS PATIENT HANDBOOK IS ALSO CURRENTLY AVAILABLE. THE PATIENT HANDBOOK CONTAINS A SECTION ON ¿CARING FOR THE PERCUTANEOUS LEAD¿; HOWEVER, ALL HEARTMATE II LVAD DRIVELINES HAVE THE POTENTIAL FOR WIRE/SHIELD BREAKDOWN TO OCCUR DEPENDENT UPON LENGTH OF USE AND PATIENT HANDLING. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED ON (B)(6) 2020 DUE TO DRIVELINE DAMAGE AND PASSED AWAY ON (B)(6) 2020 DUE TO HYPOXIC BRAIN INJURY CAUSED BY PUMP STOPPAGE. THE MAIN CAUSE OF DEATH WAS NOTED TO BE DUE TO DEVICE MALFUNCTION.

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    RELATED MANUFACTURER REPORT NUMBER: 2916596-2020-03679. IT WAS REPORTED THAT THE PATIENT HAD A SYNCOPAL EPISODE AND LOST CONSCIOUSNESS AT HOME WITH RED HEART ALARM. THE CAREGIVER CHANGED THE POWER SOURCE FROM BATTERY TO POWER MODULE, BUT THE ALARM DID NOT GO OFF. THE CONTROLLER WAS REPLACED BY CAREGIVER. ONCE THE CONTROLLER WAS CHANGED, THE PUMP OPERATION RESUMED AND THE ALARM WAS GONE. THE PATIENT WAS TAKEN TO THE HOSPITAL, BUT HIS CONSCIOUSNESS DID NOT RECOVER. UPON ARRIVAL AT THE HOSPITAL, THE PATIENT WAS IN VENTRICULAR FIBRILLATION. SEVERAL DEFIBRILLATIONS WERE TRIED. AFTER ABOUT AN HOUR, THE VENTRICULAR FIBRILLATION WAS STABILIZED BUT THE PATIENT WAS SUFFERED FROM THE BRAIN ANOXIA-COMA. MEDICAL ENGINEER FOUND A HISTORY OF PUMP OFF IN THE DEVICE HISTORY BEFORE THE CONTROLLER WAS REPLACED. THERE WAS CONCERN OF DRIVELINE FRACTURE. LOG FILE ANALYSIS SHOWED PUMP STOPS. THIS APPEARED TO HAVE BEEN THE RESULT OF A DRIVELINE DISCONNECT. THE CONTROLLER CONTINUED TO MONITOR PUMP DATA FOR ANOTHER 23 MINUTES BEFORE LOSING POWER. FOLLOWING THE CONTROLLER CHANGE, THE PUMP MADE SEVERAL ATTEMPTS TO RESTART AND RAMP UP SPEED. AFTER EVENTUAL STARTUP THE LOG NOTED A FEW LOW FLOW EVENTS THAT CLEARED. THERE WERE SEVERAL LOW POWER ADVISORIES WHILE CONNECTED TO BATTERY POWER ALSO NOTED. ALTHOUGH LOG FILE REVIEW SHOWED THE DRIVELINE DISCONNECTED, THE CAREGIVER SAID THE DRIVELINE WAS CONNECTED TO THE CONTROLLER. THE PATIENT PASSED AWAY ON (B)(6) 2020. THE CAUSE OF DEATH IS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824194 HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, JP VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 104911JPN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Hospitalization| R| D HEARTMATE II EPC CONTROLLER.| HEARTMATE II EPC CONTROLLER