BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 21610130 · Received March 14, 2025

    Report

    Report Number
    2916596-2025-01585
    Event Type
    Malfunction
    Date Received
    March 14, 2025
    Date of Event
    February 27, 2025
    Report Date
    May 7, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF OUTFLOW GRAFT OBSTRUCTION (OGO) COULD NOT BE CONFIRMED AS NO IMAGES WERE SUBMITTED FOR REVIEW AND THE DEVICE REMAINS IN USE. A SPECIFIC CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER REGARDING THE EVENT; HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED. THE PATIENT REMAINS ONGOING ON HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM, SERIAL NUMBER (B)(6), WITH NO FURTHER ISSUES REPORTED AT THIS TIME. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE CURRENT REVISIONS OF THE IFU AND PATIENT HANDBOOK CAN BE FOUND ON THE EIFU PAGE OF THE ABBOTT WEBSITE. THE HEARTMATE 3 LVAS IFU IS CURRENTLY AVAILABLE. 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 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. SECTION 5, 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." SECTION 5, 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". NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A PATIENT WITH KNOWN OUTFLOW GRAFT OBSTRUCTION (OGO) BASED ON COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA). THERE WAS AN ECHOCARDIOGRAM (ECHO) WITH WORSENING VELOCITY, THEREFORE THERE WAS CONCERN ABOUT WORSENING OGO. THE EVENT LOG CONTAINED CLUSTERS OF PULSATILITY INDEX (PI) EVENTS AS WELL AS ROUTINE POWER SOURCE CHANGES. TECH SERVICES WAS UNABLE TO CONFIRM THE PRESENCE OF AN OGO BASED ON THE LOG FILES PROVIDED. THE PATIENT CAN BE MONITORED FOR REDUCED FLOW WITH NO IMPROVEMENT BACK TO BASELINE OR PERSISTENT LOW FLOW ALARMS. NO UNUSUAL ROTOR FAULTS, PUMP TEMPERATURE, OR ANY OTHER ABNORMAL PUMP FAULTS WERE SEEN IN THE LOG. BASED ON THE DATA VISIBLE IN THE LOG FILE THE MECHANICAL CIRCULATORY SUPPORT (MCS) EQUIPMENT WAS OPERATING AS INTENDED ELECTRONICALLY AND MECHANICALLY. PATIENT SUPPORT WAS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641896 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 7190082 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female