BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 22983315 · Received September 5, 2025

    Report

    Report Number
    2916596-2025-05816
    Event Type
    Injury
    Date Received
    September 5, 2025
    Date of Event
    July 5, 2025
    Report Date
    October 15, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Removal / Correction Number
    FA-Q124-HF-1
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: CODES CORRECTED. MANUFACTURER'S INVESTIGATION CONCLUSION: EVALUATION OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) SERIAL NUMBER (B)(6), CONFIRMED AN EXTRINSIC OUTFLOW GRAFT OBSTRUCTION. (B)(6) WAS RETURNED ASSEMBLED WITH THE PUMP CABLE SEVERED APPROXIMATELY 7.5¿ FROM THE PUMP HEADER. THE DISTAL PORTION OF THE PUMP CABLE AND THE MODULAR CABLE WERE NOT RETURNED. THE OUTFLOW GRAFT WAS RETURNED ATTACHED TO THE PUMP COVER OUTLET PORT WITH THE OUTFLOW GRAFT BEND RELIEF ENGAGED TO THE GRAFT HARDWARE. THE APICAL CUFF WAS RETURNED SECURED WITH THE CUFF LOCK FULLY ENGAGED. APPROXIMATELY 7¿ OF THE OUTFLOW GRAFT WAS RETURNED WITH THE SEALED OUTFLOW GRAFT BEND RELIEF HARDWARE PROPERLY ENGAGED TO THE GRAFT HARDWARE. EXAMINATION OF THE SEALED OUTFLOW GRAFT CONFIRMED A LONGITUDINAL CREASE ALONG THE PROXIMAL PORTION OF THE GRAFT THAT WAS COVERED BY THE BEND RELIEF. REMOVAL OF THE BEND RELIEF FOUND THAT THE NORMAL TISSUE ACCUMULATION ON THE EXTERIOR OF THE GRAFT HAD FILLED IN THE CREASE, INDICATING THAT THE CREASE HAD BEEN PRESENT FOR AN UNDETERMINED PERIOD OF TIME DURING SUPPORT. THE SPECIFIC CAUSE OF THE CREASE COULD NOT BE DETERMINED BUT THE OBSERVATION IS CONSISTENT WITH EOGO. A CORRECTIVE ACTION HAS BEEN OPENED TO FURTHER INVESTIGATE EXTRINSIC OUTFLOW GRAFT OBSTRUCTIONS. 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 (LVAD) EVENT AND PERIODIC LOG FILES RETRIEVED FROM THE RETURNED DEVICE APPEARED TO CAPTURE THE DEVICE FUNCTIONING AS INTENDED. MLP-023475 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 LVAS IFU, REV. D AND THE HEARTMATE 3 PATIENT HANDBOOK, REV. AN 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. CHAPTER 5 OF THE IFU, ¿SURGICAL PROCEDURES¿, CONTAINS INFORMATION ON "PREPARING THE SEALED OUTFLOW GRAFT" AND EXPLAINS THAT PRIOR TO IMPLANTATION, THE BEND RELIEF SHOULD BE DISENGAGED FROM THE GRAFT FOR THE DE-AIRING PROCEDURE. CHAPTER 5 ALSO CONTAINS A SUB-CHAPTER ON "ATTACHING THE SEALED OUTFLOW GRAFT TO THE AORTA", WHICH INSTRUCTS THE USER TO STRETCH THE GRAFT COMPLETELY AND THEN MEASURE AND CUT THE SEALED OUTFLOW GRAFT TO THE APPROPRIATE LENGTH. CHAPTER 5 OF THE IFU, UNDER "ATTACHING THE SEALED OUTFLOW GRAFT TO THE PUMP", INSTRUCTS THE USER TO VERIFY THAT THE OUTFLOW 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. CHAPTER 5 OF THE IFU, UNDER "DE-AIRING THE PUMP", CAUTIONS THE USER: "DO NOT ROTATE/TWIST THE SEALED GRAFT. CHECK THE ALIGNMENT OF THE BLACK LINE ON THE GRAFT TO VERIFY THAT THE SEALED GRAFT IS NOT TWISTED OR KINKED." THIS CHAPTER ALSO EXPLAINS HOW TO ATTACH THE BEND RELIEF. CHAPTER 5 OF THE IFU, 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." 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.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A TRANSPLANT DUE TO EXTRINSIC OUTFLOW GRAFT OBSTRUCTION (EOGO). LOG FILES WERE NOT PROVIDED. THE PUMP WOULD BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2225187 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 7671831 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Male Required Intervention| O