BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)

    MDR report key: 9696338 · Received February 11, 2020

    Report

    Report Number
    2916596-2020-00392
    Event Type
    Injury
    Date Received
    February 11, 2020
    Date of Event
    January 15, 2020
    Report Date
    April 16, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011224
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D10, D4, H3, H4: ADDITIONAL INFORMATION SECTION D7: CORRECTION MANUFACTURER'S INVESTIGATION CONCLUSION: INCIDENTAL FINDINGS: HIPOT TESTING OF THE DRIVELINE REVEALED A BREACH IN THE ORANGE WIRE APPROXIMATELY 4.5¿ FROM THE PUMP HOUSING, WHICH COULD HAVE RESULTED IN PUMP STOPS OR LOW SPEED EVENTS WHILE CONNECTED TO A TETHERED POWER SOURCE SUCH AS THE POWER MODULE. IN ADDITION, SEVERAL OUTER SILICONE JACKET TEARS WERE OBSERVED APPROXIMATELY 4¿ THROUGH 20¿ FROM THE CONTROLLER CONNECTOR; HOWEVER, THE UNDERLYING BIONATE DID NOT REVEAL ANY EVIDENCE OF DAMAGE. THE EVALUATION OF HEARTMATE II LVAS, IDENTIFIED AN EXTERNAL DRIVELINE ISSUE THAT COULD HAVE CONTRIBUTED TO THE REPORTED DRIVELINE FAULTS, WHICH WERE CONFIRMED THROUGH THE EVALUATION OF THE SUBMITTED SYSTEM CONTROLLER LOG FILES. ADDITIONALLY, THIS EVALUATION IDENTIFIED AN INTERNAL DRIVELINE ISSUE THAT COULD HAVE RESULTED IN PUMP STOPS OR LOW SPEED EVENTS WHILE CONNECTED TO A TETHERED POWER SOURCE. THE SUBMITTED LOG FILE PRIOR TO THE CONTROLLER EXCHANGE CAPTURED SEVERAL DRIVELINE FAULTS AND ASSOCIATED YELLOW WRENCH ADVISORY EVENTS FROM 12JAN2020 AT 06:00:16 PM THROUGH THE REMAINDER OF THE DATA, WHICH RANGED THROUGH 15JAN2020 AT 10:57:27 AM. THE SUBMITTED LOG FILES FROM AFTER THE CONTROLLER EXCHANGE CAPTURED THE DRIVELINE BEING CONNECTED TO THE CONTROLLER ON 15JAN2020 AT 12:26:24 PM. FURTHER DRIVELINE FAULTS AND ASSOCIATED YELLOW WRENCH ADVISORY EVENTS WERE THEN OBSERVED STARTING ON 15JAN2020 AT 12:36:04 PM. DESPITE THESE FINDINGS, THE PUMP APPEARED TO HAVE FUNCTIONED AS INTENDED ABOVE THE LOW SPEED LIMIT THROUGHOUT THE DURATION OF THE DATA. THE ACCOUNT COMMUNICATED THAT THE PATIENT UNDERWENT A PUMP EXCHANGE ON (B)(6)2020 . (B)(6) WAS RETURNED ASSEMBLED WITH THE DRIVELINE SEVERED APPROXIMATELY 8.5¿ FROM THE PUMP HOUSING. THE REMAINDER OF THE DRIVELINE WAS RETURNED MEASURING APPROXIMATELY 37.5¿. METAL BRAIDED SHIELD BREAKDOWN WAS OBSERVED ALONG THE EXTERNAL PORTION OF THE DRIVELINE WITH SEVERE BREAKDOWN ADJACENT TO THE CONTROLLER CONNECTOR AND APPROXIMATELY 2.5¿ THROUGH 4.5¿, 15¿, 19.5¿, AND 23.5¿ FROM THE METAL CONNECTOR. INTERNAL METAL BRAIDED SHIELD BREAKDOWN WAS ALSO OBSERVED APPROXIMATELY 4.5¿ AND 12¿ THROUGH 12.5¿ FROM THE PUMP HOUSING. HIPOT TESTING OF THE DRIVELINE REVEALED A BREACH IN THE ORANGE WIRE APPROXIMATELY 4.5¿ FROM THE PUMP HOUSING, EXPOSING THE INNER CONDUCTORS. THIS DAMAGE APPEARS CONSISTENT WITH FATIGUE FAILURE DUE TO REPETITIVE FLEXING AND ABRASION AGAINST THE METAL BRAIDED SHIELD. ADDITIONALLY, APPLICATION OF A TENSILE FORCE TO THE BLACK WIRE REVEALED THINNING OF THE INSULATION APPROXIMATELY 24¿ FROM THE CONTROLLER CONNECTOR, SUGGESTING THAT THE INNER CONDUCTORS WERE FRACTURED AT THIS LOCATION. THIS DAMAGE APPEARS CONSISTENT WITH FATIGUE FAILURE DUE TO REPETITIVE FLEXING. IF THE DAMAGED INNER CONDUCTORS OF THE BLACK WIRE CAUSED AN OPEN CIRCUIT CONDITION, IT WOULD HAVE BEEN DETECTED BY THE POCKET CONTROLLER WHEN COMPARING WIRE CURRENTS, WHICH COULD HAVE RESULTED IN THE DRIVELINE FAULTS AND ASSOCIATED YELLOW WRENCH ADVISORY EVENTS OBSERVED IN THE SUBMITTED LOG FILES. IN ADDITION, IF THE EXPOSED INNER CONDUCTORS OF THE ORANGE WIRE MADE CONTACT WITH THE METAL BRAIDED SHIELD WHILE THE SYSTEM CONTROLLER WAS CONNECTED TO A TETHERED POWER SOURCE SUCH AS THE POWER MODULE, THE RESULTING ELECTRICAL SHORT TO GROUND COULD HAVE RESULTED IN PUMP STOPS OR LOW SPEED EVENTS. THE HEARTMATE II LVAS PATIENT HANDBOOK CONTAINS A SECTION ON ¿CARING FOR THE DRIVELINE¿; HOWEVER, ALL HEARTMATE II LVAD DRIVELINES HAVE THE POTENTIAL FOR WIRE/SHIELD BREAKDOWN TO OCCUR DEPENDENT UPON LENGTH OF USE AND PATIENT HANDLING. SECTION 5 ENTITLED ¿ALARMS AND TROUBLESHOOTING¿ OUTLINES ALL SYSTEM CONTROLLER ALARMS, AS WELL AS HOW TO RESPOND TO EACH ALARM CONDITION. HEARTMATE II LVAS IFU OUTLINES INDICATIONS OF DRIVELINE DAMAGE AS WELL AS HOW TO RESPOND TO SUCH EVENTS. SECTION 7 ENTITLED ¿ALARMS AND TROUBLESHOOTING¿ OUTLINES ALL SYSTEM CONTROLLER ALARMS, AS WELL AS HOW TO RESPOND TO EACH ALARM CONDITION. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE REFERENCED DISPLAY ISSUE WITH THE FIRST SYSTEM CONTROLLER WAS REPORTED IN MFR. REPORT #2916596-2020-00393. THE REFERENCED DISPLAY ISSUE WITH THE SECOND SYSTEM CONTROLLER WAS REPORTED IN MFR. REPORT #2916596-2020-00667. THE REFERENCED PREVIOUS DRIVELINE REPAIR WAS REPORTED IN MFR. REPORT #2916596-2017-01329. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A DRIVELINE FAULT ALARM AND BANNER ON THE SYSTEM MONITOR. THE POCKET CONTROLLER DID NOT DISPLAY A YELLOW WRENCH OR RED HEART LIGHT. THIS OCCURRED WHEN THEY WERE CONNECTED TO THE GROUNDED POWER MODULE CABLE IN LVAD CLINIC. PATIENT WAS SUBSEQUENTLY CHANGED TO AN UNGROUNDED CABLE AND THE FAULT BANNER PERSISTED. THE PATIENT DENIED ANY ALARMS AS AN OUTPATIENT. PATIENT HAD A DRIVELINE REPAIR FOR PRESUMED SHORT TO SHIELD (B)(6) 2017 AND HAD NO ISSUES AFTER THAT. THE SYSTEM CONTROLLER WAS EXCHANGED AND THE POWER CABLE WAS DISCONNECTED 20 TIMES AS PART OF TROUBLESHOOTING. THE BANNER OF DRIVELINE FAULT DID DISAPPEAR ON THE NEW CONTROLLER. TWO LOG FILES WERE SUBMITTED. DURING THE ANALYSIS OF THE LOG FILE IT WAS OBSERVED THERE WERE NO UNUSUAL EVENTS IN THE LOG FILE FOR THE NEW CONTROLLER BUT IN THE OTHER LOG FILE THE DRIVELINE FAULT DID RETURN. THE DRIVELINE FAULT ALARM WAS BELIEVED TO BE TRUE. THE X-RAYS WERE UNREMARKABLE. PATIENT UNDERWENT PUMP EXCHANGE ON (B)(6) 2020 FOR DRIVELINE FAULT ALARMS. THE PATIENT WAS UNABLE TO UNDERGO ANOTHER DRIVELINE REPAIR DUE TO PRIOR DRIVELINE REPAIR BEING REPLACED TOO CLOSE TO THE EXIT SITE. PATIENT WAS RECOVERING IN INTENSIVE CARE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156047 HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS) VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106015 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R