BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 24191416 · Received January 27, 2026

    Report

    Report Number
    2916596-2026-00325
    Event Type
    Injury
    Date Received
    January 27, 2026
    Date of Event
    January 11, 2026
    Report Date
    March 16, 2026
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: CODES CORRECTED. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    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: THE ACCOUNT REPORTED THAT THE PATIENT UNDERWENT A ROUTINE HEART TRANSPLANTATION. THERE WERE NO REPORTS OF PROBLEMS REGARDING THE DEVICE OPERATION. (B)(6) WAS RETURNED ASSEMBLED WITH THE PUMP CABLE SEVERED APPROXIMATELY 5¿ FROM THE PUMP HEADER. THE DISTAL PORTIONS OF THE PUMP CABLE AND THE MODULAR CABLE WERE ALSO RETURNED. APPROXIMATELY 3¿ OF THE SEALED OUTFLOW GRAFT WAS RETURNED ATTACHED TO THE PUMP COVER OUTLET PORT WITH THE BEND RELIEF ENGAGED TO THE GRAFT ATTACHMENT. THE APICAL CUFF WAS RETURNED SECURED WITH THE CUFF LOCK FULLY ENGAGED. UPON DISASSEMBLY OF THE RETURNED PUMP, VISUAL EXAMINATION OF THE PUMP¿S BLOOD-CONTACTING SURFACES REVEALED NO EVIDENCE OF DEVELOPED OR ADHERED DEPOSITIONS OR THROMBUS FORMATIONS WITHIN THE DEVICE THAT WOULD HAVE CONTRIBUTED TO A FLOW OR FUNCTIONAL ISSUE. 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 CAPTURED THE PUMP FUNCTIONING AS INTENDED FOR THE DURATION OF THE LOG FILES. MLP-022096 WAS CLEANED, REBUILT, AND FUNCTIONALLY TESTED ON A MOCK CIRCULATORY LOOP. THE DEVICE OPERATED AS INTENDED AND IN ACCORDANCE WITH MANUFACTURING SPECIFICATIONS. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) AND THE HEARTMATE 3 LVAS PATIENT HANDBOOK , ARE CURRENTLY AVAILABLE. ALTHOUGH NO DEVICE RELATED ISSUES WERE REPORTED BY THE ACCOUNT, THE IFU LISTS POTENTIAL ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. 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. THE SECTION ¿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. THIS SECTION ALSO INSTRUCTS THE USER TO CHECK THE DRIVELINE DAILY FOR SIGNS OF DAMAGE, SUCH AS CUTS, HOLES, OR TEARS AND TO COUNSEL PATIENTS TO INFORM THEIR HOSPITAL CONTACT IMMEDIATELY IF THEY FIND SIGNS OF DRIVELINE DAMAGE. THE PATIENT HANDBOOK CONTAINS INFORMATION REGARDING HOW TO CLEAN AND CARE FOR THE DRIVELINE. THIS HANDBOOK INSTRUCTS THE USER TO CHECK THE DRIVELINE DAILY FOR SIGNS OF DAMAGE AND TO CALL YOUR HOSPITAL CONTACT RIGHT AWAY IF THE DRIVELINE IS DAMAGED. THE SECTION ¿ALARMS AND TROUBLESHOOTING¿ CAUTIONS THE USER NOT TO TWIST, KINK, OR SHARPLY BEND THE DRIVELINE. THE HANDBOOK ALSO INSTRUCTS THE USER TO ¿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.¿ THE SECTION ¿ALARMS AND TROUBLESHOOTING¿ CAUTIONS THE USER NOT TO TWIST, KINK, OR SHARPLY BEND THE DRIVELINE. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS ADDITIONALLY REPORTED THAT THE TRANSPLANT WAS ROUTINE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS TRANSPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251305 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 7616525 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Required Intervention