BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 22806519 · Received August 14, 2025

    Report

    Report Number
    2916596-2025-05256
    Event Type
    Injury
    Date Received
    August 14, 2025
    Date of Event
    July 30, 2025
    Report Date
    August 22, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    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 COMPLETED.

    Additional Manufacturer Narrative · 0

    B2 - OUTCOMES ATTRIBUTED TO ADVERSE: CORRECTED. MANUFACTURER'S INVESTIGATION CONCLUSION: EVALUATION OF HEARTMATE 3, LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6), DID NOT REVEAL ANY DEVICE-RELATED ISSUES. IT WAS REPORTED THAT THE PATIENT UNDERWENT A ROUTINE HEART TRANSPLANT. NO DEVICE-RELATED ISSUES WERE REPORTED. (B)(6) WAS RETURNED ASSEMBLED WITH THE PUMP CABLE SEVERED APPROXIMATELY 8.5" FROM THE PUMP HEADER. THE DISTAL PORTION OF THE PUMP CABLE AND THE MODULAR CABLE WERE NOT RETURNED. APPROXIMATELY 5.0¿ 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. THE APICAL CUFF WAS NOT RETURNED. THE CUFF LOCK WAS UNREMARKABLE. UPON DISASSEMBLY OF THE PUMP BODY, EXAMINATION OF THE BLOOD-CONTACTING SURFACES REVEALED NO EVIDENCE OF DEVELOPED DEPOSITIONS OR THROMBUS FORMATIONS THAT WOULD HAVE CONTRIBUTED TO A 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 OPERATING AS INTENDED. MLP-042733 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), REV. D, IS CURRENTLY AVAILABLE. THE CURRENT REVISION OF THE IFU CAN BE FOUND ON THE EIFU PAGE OF THE ABBOTT WEBSITE. ALTHOUGH NO DEVICE RELATED ISSUES WERE REPORTED BY THE ACCOUNT, THE IFU LISTS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS. 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 UNDERWENT A HEART TRANSPLANT. WHETHER THE OUTCOME WAS DEVICE OR THERAPY RELATED WAS NOT PROVIDED BY THE CUSTOMER. IT WAS A ROUTINE TRANSPLANT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE TRANSPLANT WAS NOT SECONDARY TO DEVICE OR THERAPY RELATED ISSUE. THE PATIENT HAD BEEN LISTED PER PROTOCOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1557517 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US L00000197 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Male Congenital Anomaly| R