BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)

    MDR report key: 18861610 · Received March 7, 2024

    Report

    Report Number
    2916596-2024-01466
    Event Type
    Injury
    Date Received
    March 7, 2024
    Date of Event
    March 4, 2024
    Report Date
    April 24, 2024
    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
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6) AND THE REPORTED EVENT OF GASTROINTESTINAL BLEEDING COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. REVIEW OF THE SUBMITTED LOG FILES CONFIRMED SILENCED DRIVELINE FAULT ALARMS. BASED ON PREVIOUS EXPERIENCED WITH THE HEARTMATE II LVAS AND SIMILAR REPORTED EVENTS, THESE EVENTS COULD BE INDICATIVE OF AN ISSUE WITH THE DRIVELINE. THE SUBMITTED LOG FILES COLLECTIVELY CONTAINED EVENTS FROM 27FEB2024 THROUGH 14MAR2024. SEVERAL SILENCED DRIVELINE FAULT ALARMS WERE CAPTURED. NO OTHER NOTABLE ALARMS OR EVENTS WERE CAPTURED. THE PUMP APPEARED TO FUNCTION AS INTENDED AT THE FIXED SPEED. THE PATIENT REMAINS ONGOING ON HEARTMATE II LVAS, SERIAL NUMBER (B)(6) WITH NO FURTHER COMPLAINTS REPORTED AT THIS TIME. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) AND THE DRIVELINE, SERIAL NUMBER (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) REV. C, AND THE HEARTMATE II LVAS PATIENT HANDBOOK REV. C ARE CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS POTENTIAL ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE II LVAS, INCLUDING BLEEDING. SECTION 6 OF THE IFU, ¿PATIENT CARE AND MANAGEMENT¿ PROVIDES INFORMATION REGARDING ANTICOAGULATION, INCLUDING THE RECOMMENDED INR (INTERNATIONAL NORMALIZED RATIO) VALUES. THIS SECTION ALSO DISCUSSES DAMAGE DUE TO WEAR AND FATIGUE OF THE DRIVELINE. THIS SECTION ALSO CONTAINS INFORMATION ON ¿CARING FOR THE DRIVELINE¿ (UNDER ¿ONGOING SYSTEM ASSESSMENT AND CARE¿) AND PROVIDES POSSIBLE INDICATIONS OF DRIVELINE DAMAGE AS WELL AS HOW TO RESPOND TO SUCH EVENTS. THIS SECTION ALSO INSTRUCTS TO CHECK THE DRIVELINE DAILY FOR SIGNS OF DAMAGE, SUCH AS CUTS, HOLES, OR TEARS. SECTION 8 ¿EQUIPMENT STORAGE AND CARE¿ ALSO CONTAINS INFORMATION ON ¿CARE OF THE DRIVELINE,¿ AND PROVIDES POSSIBLE INDICATIONS OF DRIVELINE DAMAGE. SECTION 7 OF THE IFU, "ALARMS AND TROUBLESHOOTING" OUTLINES SYSTEM CONTROLLER ALARMS AS WELL AS HOW TO RESPOND TO EACH ALARM CONDITION. THE 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 4 OF THE HANDBOOK, ¿LIVING WITH THE HEARTMATE II¿ CONTAINS INFORMATION ON CARING FOR THE DRIVELINE. SECTION 5 OF THE HANDBOOK, "ALARMS AND TROUBLESHOOTING" OUTLINES 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED FOR A GASTROINTESTINAL (GI) BLEED CONFIRMED BY LAB TESTING. THE PATIENT HAD A HISTORY OF COAGULOPATHY AND HAD A STENT IN THE OUTFLOW GRAFT LAST YEAR (CS-193357). THE PATIENT HAD 199 DRIVELINE FAULT ALARMS. THE EVENT LOG FILES CAPTURED MULTIPLE DRIVELINE FAULT ALARMS. IT WAS NOTED THAT THE YEAR ON THE SYSTEM CONTROLLER WAS WRONG. A SYSTEM CONTROLLER EXCHANGE WAS PERFORMED. THE NEW SYSTEM CONTROLLER WAS TESTED WITH 25 INTENTIONAL POWER CABLE DISCONNECTS AND NO DRIVELINE FAULT ALARMS OCCURRED OVER THE SPAN OF THE EVENT LOG FILES. THE PATIENT HAD 28 DRIVELINE FAULTS OVERNIGHT ON THE NEW SYSTEM CONTROLLER. A DRIVELINE X-RAY WAS SCHEDULED. IT WAS RECOMMENDED TO KEEP THE PATIENT ON BATTERIES OR AN UNSHIELDED PATIENT CABLE IN CASE THERE WAS POSSIBLE CONDUCTOR OR WIRE DAMAGE IN THE DRIVELINE.

    Description of Event or Problem · 0

    IT WAS ADDITIONALLY REPORTED THAT ADDITIONAL EVENT LOG FILES CAPTURED MORE DRIVELINE FAULT ALARMS. THE PHASE A ISSUE PERSISTED. DUE TO THE PATIENT'S MEDICAL HISTORY, IT WAS DETERMINED THAT THEY WERE NOT A PUMP EXCHANGE CANDIDATE. THE DRIVELINE WAS NOT FIXED OR SPLICED. THE PLAN OF CARE WAS TO CHECK THE DRIVELINE ISSUES MONTHLY. RELATED MFR #: (B)(4). CAPTURES STENT IN THE OUTFLOW GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2195599 HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS) VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106015 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Hospitalization| R| L