BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 21893105 · Received April 23, 2025

    Report

    Report Number
    2916596-2025-02254
    Event Type
    Death
    Date Received
    April 23, 2025
    Date of Event
    March 12, 2025
    Report Date
    June 12, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Removal / Correction Number
    FA-Q124-HF-1
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE
    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

    SECTION E3 CORRECTION. SECTION H6 CORRECTION: HEALTH EFFECT - IMPACT CODE UNEXPECTED MEDICAL INTERVENTION ADDED. SECTION H6 CORRECTION: MEDICAL DEVICE PROBLEM CODE 2993 - ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM ADDED. MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER: (B)(6) AND THE REPORTED HEMORRHAGIC STROKE AND PATIENT OUTCOME COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. FURTHERMORE, EVALUATION OF HEARTMATE 3 LVAS, SERIAL NUMBER: (B)(6), CONFIRMED EOGO. A SPECIFIC CAUSE FOR THIS FINDING COULD NOT BE CONCLUSIVELY DETERMINED. (B)(6) WAS RETURNED ASSEMBLED WITH THE PUMP CABLE FULLY INTACT. THE MODULAR CABLE WAS ALSO RETURNED ATTACHED TO THE PUMP CABLE. APPROXIMATELY 4.0¿ OF THE SEALED OUTFLOW GRAFT WAS RETURNED ATTACHED TO THE PUMP COVER OUTLET PORT WITH THE OUTFLOW GRAFT BEND RELIEF PROPERLY ENGAGED TO THE GRAFT HARDWARE. TWO ADDITIONAL SEGMENTS OF THE OUTFLOW GRAFT WERE RETURNED DETACHED FROM THE PUMP, MEASURING 1.5¿ AND 5.5¿, RESPECTIVELY. THE APICAL CUFF WAS RETURNED WITH THE CUFF LOCK FULLY ENGAGED. EXAMINATION OF THE TEXTURED, BLOOD-CONTACTING SURFACES REVEALED NO EVIDENCE OF DEVELOPED OR ADHERED THROMBUS FORMATIONS THAT WOULD HAVE CONTRIBUTED TO A FUNCTIONAL ISSUE DURING SUPPORT. UPON REMOVAL OF THE OUTFLOW GRAFT BEND RELIEF, A SMOOTH, BIOLOGICAL ACCUMULATION WAS OBSERVED ALONG THE PROXIMAL END OF THE 4.0¿ OUTFLOW GRAFT SEGMENT UNDERNEATH THE BEND RELIEF. THE TISSUE WAS DISPLACED DURING DISASSEMBLY, REVEALING THAT IT HAD BEEN WELL-FORMED INTO THE GEOMETRY OF A LENGTHWISE CREASE ALONG THE PROXIMAL END OF THE GRAFT. THE REMAINDER OF THE OUTFLOW GRAFT WAS UNREMARKABLE. THE TEXTURED SURFACE OF THE GRAFT ATTACHMENT REVEALED NO EVIDENCE OF DEVELOPED OR ADHERED DEPOSITIONS OR THROMBUS FORMATIONS. THE O-RING IN THE GRAFT ATTACHMENT WAS PRESENT AND SEATED PROPERLY. THE LUMEN OF THE SEALED OUTFLOW GRAFT SEGMENTS REVEALED NO EVIDENCE OF DEVELOPED OR ADHERED DEPOSITIONS OR THROMBUS FORMATIONS. THESE FINDINGS APPEAR CONSISTENT WITH EOGO DURING SUPPORT. A SPECIFIC CAUSE FOR THE OBSERVED DEFORMATION IN THE OUTFLOW GRAFT COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. VISUAL INSPECTION OF THE PUMP ROTOR AND ROTOR WELL DID NOT REVEAL ANY OBVIOUS SURFACE SCRATCHES OR DEFECTS. THE LEFT VENTRICULAR ASSIST DEVICE (LVAD) EVENT AND PERIODIC LOG FILES RETRIEVED FROM THE RETURNED DEVICE APPEARED TO CAPTURE THE DEVICE FUNCTIONING AS INTENDED. (B)(6) WAS CLEANED, REBUILT, AND FUNCTIONALLY TESTED ON A MOCK CIRCULATORY LOOP. THE DEVICE OPERATED AS INTENDED AND IN ACCORDANCE WITH MANUFACTURING SPECIFICATIONS. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS POTENTIAL ADVERSE EVENTS, INCLUDING STROKE, BLEEDING, AND DEATH, THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS. SECTION 5 OF THE IFU, ¿SURGICAL PROCEDURES¿, OUTLINES CONSIDERATIONS FOR PUMP PLACEMENT AND PROVIDES INSTRUCTIONS REGARDING THE PREPARATION, INSTALLATION, AND ORIENTATION OF THE SEALED OUTFLOW GRAFT. SECTION 5, UNDER "ATTACHING THE SEALED OUTFLOW GRAFT TO THE PUMP," INSTRUCTS THE USER TO VERIFY THAT THE GRAFT IS NOT TWISTED OR KINKED BY CHECKING THE POSITION OF THE BLACK LINE ON THE GRAFT ABOVE AND BELOW THE BEND RELIEF AND ENSURING THAT THE LINE IS STRAIGHT. THIS SECTION UNDER "PREIMPLANT PROCEDURES" AND "IMPLANT PROCEDURES" CAUTIONS THE USER: "THE SEALED OUTFLOW GRAFT MUST NOT BE KINKED OR POSITIONED WHERE IT COULD ABRADE AGAINST A PUMP COMPONENT OR BODY STRUCTURE" AND "STRETCH THE SEALED OUTFLOW GRAFT COMPLETELY PRIOR TO MEASURING AND CUTTING THE GRAFT TO THE APPROPRIATE LENGTH. SECTION 5 OF THE IFU ALSO CAUTIONS THE USER THAT SHARP BENDS, TWISTS, OR KINKS IN THE DRIVELINE MAY MAKE IT MORE SUSCEPTIBLE TO WEAR AND FATIGUE OVER TIME. SECTION 6 OF THE IFU, "PATIENT CARE AND MANAGEMENT", CAUTIONS THE USER TO AVOID PULLING ON OR MOVING THE DRIVELINE. THIS SECTION FURTHER CAUTIONS: "DO NOT TWIST, KINK, OR SHARPLY BEND THE DRIVELINE, SYSTEM CONTROLLER POWER CABLES, THE POWER MODULE PATIENT CABLE, OR THE MOBILE POWER UNIT PATIENT CABLE, WHICH MAY CAUSE DAMAGE TO THE WIRES INSIDE, EVEN IF EXTERNAL DAMAGE IS NOT VISIBLE. DAMAGE TO THE DRIVELINE OR CABLES COULD CAUSE THE LEFT VENTRICULAR ASSIST DEVICE TO STOP. IF THE DRIVELINE OR CABLES BECOME TWISTED, KINKED, OR BENT, CAREFULLY UNRAVEL AND STRAIGHTEN." THIS SECTION (UNDER "CARING FOR THE DRIVELINE") INSTRUCTS THE USER TO CHECK THE DRIVELINE DAILY FOR SIGNS OF DAMAGE, SUCH AS CUTS, HOLES, OR TEARS. FURTHERMORE, SECTION 6 OF THE IFU (UNDER "ANTICOAGULATION") OUTLINES THE RECOMMENDED ANTICOAGULATION REGIMEN, INCLUDING INR RANGE FOR PATIENTS USING THE HEARTMATE 3 LVAS, AS WELL AS THE SUGGESTED ANTICOAGULATION MODIFICATIONS IN THE EVENT THAT THERE IS A RISK OF BLEEDING. SECTION 7 OF THE IFU, "ALARMS AND TROUBLESHOOTING" PROVIDES ADDITIONAL INSTRUCTIONS REGARDING DRIVELINE CARE IN A SUB-SECTION ENTITLED "WHAT NOT TO DO: DRIVELINE AND CABLES". FINALLY, SECTION 8 OF THE IFU, "EQUIPMENT STORAGE AND CARE" (UNDER "CLEANING THE DRIVELINE") EXPLAINS THAT AS NEEDED, THE USER CAN CLEAN EXTERIOR SURFACES OF THE DRIVELINE CABLES WITH A DAMP, LINT-FREE CLOTH. IF MORE AGGRESSIVE CLEANING IS NEEDED, WARM WATER AND MILD DISH SOAP SHOULD BE USED. THE HEARTMATE 3 LVAS PATIENT HANDBOOK IS ALSO CURRENTLY AVAILABLE. SECTION 4 OF THE PATIENT HANDBOOK, "LIVING WITH THE HEARTMATE III" (UNDER "CARING FOR THE DRIVELINE") CONTAINS INFORMATION REGARDING HOW TO CLEAN AND CARE FOR THE DRIVELINE. THIS SECTION INSTRUCTS THE USER: "CHECK THE DRIVELINE DAILY FOR SIGNS OF DAMAGE (CUTS, HOLES, TEARS). CALL YOUR HOSPITAL CONTACT RIGHT AWAY IF THE DRIVELINE IS DAMAGED (OR MIGHT BE DAMAGED)." AND "KEEP YOUR DRIVELINE CLEAN. WIPE OFF ANY DIRT OR GRIME. IF THE DRIVELINE GETS DIRTY, USE A TOWEL WITH MILD DISH SOAP AND WARM WATER TO GENTLY CLEAN IT. NEVER SUBMERGE THE DRIVELINE OR OTHER SYSTEM COMPONENTS IN WATER OR LIQUID." IN ADDITION, SECTION 5 OF THE PATIENT HANDBOOK, "ALARMS AND TROUBLESHOOTING" CONTAINS A SUB-SECTION ENTITLED "WHAT NOT TO DO: DRIVELINE AND CABLES", WHICH EXPLICITLY CAUTIONS THE USER NOT TO TWIST, KINK, OR SHARPLY BEND THE DRIVELINE. 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 SUFFERED A STROKE ON (B)(6) 2025, SHOWING WEAKNESS AND NUMBNESS ON THEIR LEFT SIDE, AND WAS ADMITTED TO THE EMERGENCY ROOM (ER). THE PATIENT'S COUMADIN (WARFARIN) WAS REVERSED, AND THE PATIENT WAS CONSERVATIVELY MANAGED AND MONITORED. A COMPUTED TOMOGRAPHY (CT) OF THE PATIENT'S HEAD WAS TAKEN, AND THEY WERE FOUND TO HAVE SUFFERED A SUBARACHNOID HEMORRHAGE (SAH), THE CAUSE OF WHICH WAS UNKNOWN. THE CUSTOMER REPORTED NO CHANGES TO THE PATIENT CONDITION OR ANTICOAGULATION STATUS THAT MAY HAVE CONTRIBUTED, AND THERE HAD BEEN NO RECENT CHANGES TO THE PATIENT'S PUMP PARAMETERS. THE PATIENT WAS TRANSFERRED TO INPATIENT HOSPICE. THE PATIENT ELECTED TO HAVE THEIR VENTRICULAR ASSIST DEVICE (VAD) TURNED OFF, AND THEY PASSED AWAY (B)(6) 2025. THE PATIENT WAS ALSO NOTED TO HAVE HAD EXTRINSIC OUTFLOW GRAFT OBSTRUCTION (EOGO) (MFR 2916596-2024-52521). THE PUMP WAS FUNCTIONING AS EXPECTED AND WAS EXPLANTED AND RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1291155 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 7472972 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Death