BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 22285669 · Received June 18, 2025

    Report

    Report Number
    2916596-2025-03817
    Event Type
    Injury
    Date Received
    June 18, 2025
    Date of Event
    March 18, 2025
    Report Date
    July 31, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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

    B2 - OUTCOMES ATTRIBUTED TO ADVERSE: CORRECTED. H6 HEALTH EFFECT - CLINICAL CODE: CORRECTED. MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6), AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. (B)(6) WAS RETURNED ASSEMBLED WITH THE PUMP CABLE SEVERED APPROXIMATELY 10.5¿ FROM THE PUMP HEADER. THE DISTAL PORTION OF THE PUMP CABLE, MODULAR CABLE, OUTFLOW GRAFT, OUTFLOW GRAFT BEND RELIEF, AND OUTFLOW GRAFT ATTACHMENT HARDWARE WERE NOT RETURNED. THE CUFF LOCK WAS DISENGAGED, AND THE APICAL CUFF WAS NOT RETURNED WITH THE DEVICE. UPON DISASSEMBLY OF THE RETURNED PUMP, EXAMINATION OF THE BLOOD-CONTACTING SURFACES REVEALED NO EVIDENCE OF DEVELOPED OR ADHERED DEPOSITIONS OR THROMBUS FORMATIONS 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 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 LVAS IFU, REV. D AND THE HEARTMATE 3 PATIENT HANDBOOK, REV. D ARE CURRENTLY AVAILABLE. THE CURRENT REVISIONS OF THE IFU AND PATIENT HANDBOOK CAN ALSO BE FOUND ON THE ELECTRONIC IFU (EIFU) PAGE OF THE ABBOTT WEBSITE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS POTENTIAL ADVERSE EVENTS, INCLUDING INFECTION (LOCAL, DRIVELINE, PUMP POCKET), THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. THE IFU AND PATIENT HANDBOOK CONTAIN INFORMATION ON HOW TO CLEAN AND CARE FOR THE DRIVELINE. SECTION 6 OF THE IFU AND SECTION 4 OF THE PATIENT HANDBOOK INSTRUCT THE USER TO CHECK THE DRIVELINE DAILY FOR SIGNS OF DAMAGE, SUCH AS CUTS, HOLES, OR TEARS. THE PATIENT HANDBOOK ALSO STATES, ¿CALL YOUR HOSPITAL CONTACT RIGHT AWAY IF THE DRIVELINE IS DAMAGED (OR MIGHT BE DAMAGED)." SECTION 7 OF THE IFU AND SECTION 5 OF THE PATIENT HANDBOOK PROVIDE ADDITIONAL INSTRUCTIONS REGARDING DRIVELINE CARE IN SUB-SECTIONS ENTITLED, "WHAT NOT TO DO: DRIVELINE AND CABLES". FURTHERMORE, SECTION 8 OF THE IFU AND SECTION 4 OF THE PATIENT HANDBOOK INSTRUCT THE USER TO CLEAN EXTERIOR SURFACES OF THE DRIVELINE CABLES WITH A DAMP, LINT-FREE CLOTH AND IF MORE AGGRESSIVE CLEANING IS NEEDED, TO USE WARM WATER AND MILD DISH SOAP. SEVERAL SECTIONS OF THE IFU AND PATIENT HANDBOOK PROVIDE CARE INSTRUCTIONS REGARDING HOW TO PREVENT INFECTION AS WELL AS SUGGESTED RESPONSES IN THE EVENT OF INFECTION. 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 HAD MULTIPLE GASTROINTESTINAL (GI) BLEEDS AND HAD BEEN OFF ANTICOAGULANTS SINCE (B)(6) 2022 (CS-212948). THE PATIENT WAS TRANSPLANTED ON (B)(6) 2025 DUE TO INFECTION SEEN ON THE POSITRON EMISSION TOMOGRAPHY (PET) SCAN. THE PUMP WAS REQUESTED TO BE SENT BACK FOR INSPECTION AND AN EXPLANT KIT WAS REQUESTED. THE PATIENT WAS DIAGNOSED WITH BACTEREMIA ON (B)(6) 2025. THE PATIENT HAD AN INFECTION SOURCE OF BACTEREMIA AND PUMP POCKET. THE PATIENT HAD PAIN ALONG THE THORACOTOMY INCISION. THE CULTURE WAS STAPH EPIDERMIDIS. TRANSPLANT RESOLVED THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1767710 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 8027270 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention| L