BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 19668046 · Received July 3, 2024

    Report

    Report Number
    2916596-2024-04090
    Event Type
    Malfunction
    Date Received
    July 3, 2024
    Date of Event
    April 2, 2024
    Report Date
    July 12, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    FURTHER REVIEWED DETERMINED THAT THIS EVENT WAS A DUPLICATE AND REPORTED UNDER MANUFACTURER REPORT NUMBER 2916596-2024-03187.

    Additional Manufacturer Narrative · 0

    SECTION A: SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. SECTION B3: DATE OF EVENT HAS BEEN ENTERED AS THE SAME AS PUBLISHED DATE (02APR2024) SINCE DATE OF DATA COLLECTION WAS NOT PROVIDED. SECTION D4: DEVICE SERIAL NUMBER WAS NOT PROVIDED, AND EXPIRATION DATE AND MANUFACTURE DATE (H4) CANNOT BE DETERMINED. THE PRIMARY UDI NUMBER IN D4 IS REFLECTIVE OF ALL AVAILABLE. ARTICLE INFORMATION: TAKLA, A., EID, F., ELBANNA, M., EID, M. M., JOSHI, A., BITAR, A., LYDON, R., & FEITELL, S. (2024). PERCUTANEOUS INTERVENTION OF LVAD OUTFLOW GRAFT OBSTRUCTION AND THROMBOSIS. METHODIST DEBAKEY CARDIOVASCULAR JOURNAL, 20(1), 9¿13. HTTPS://DOI.ORG/10.14797/MDCVJ.1360 ROCHESTER GENERAL HOSPITAL, ROCHESTER, NY, USA, SANDS-CONSTELLATION HEART INSTITUTE, ROCHESTER, NY, USA. MANUFACTURER'S INVESTIGATION CONCLUSION: REVIEW OF THE SUBMITTED IMAGING SHOWED EVIDENCE CONSISTENT WITH EXTRINSIC OUTFLOW GRAFT OBSTRUCTION (EOGO). REVIEW OF THE SUBMITTED IMAGING REVEALED EVIDENCE OF A BUILDUP OF BIODEBRIS BETWEEN THE BEND RELIEF AND THE OUTFLOW GRAFT, CONSISTENT WITH EXTRINSIC OUTFLOW GRAFT OBSTRUCTION (EOGO). THE SERIAL NUMBER OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM WAS NOT PROVIDED. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), REV. C IS CURRENTLY AVAILABLE. SECTION 1 OF THE IFU LISTS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. 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 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 "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.". NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    FURTHER REVIEWED DETERMINED THAT THIS EVENT WAS A DUPLICATE AND REPORTED UNDER MANUFACTURER REPORT NUMBER 2916596-2024-03187.

    Description of Event or Problem · 0

    IT WAS REPORTED IN THE ARTICLE ¿PERCUTANEOUS INTERVENTION OF LVAD OUTFLOW GRAFT OBSTRUCTION AND THROMBOSIS¿ THAT AN ELDERLY PATIENT, POST HEARTMATE 3 (HM3) LEFT VENTRICULAR ASSIST DEVICE (LVAD) IMPLANTATION, PRESENTED WITH RECURRENT LOW FLOW ALARMS. THE PATIENT WAS EUVOLEMIC ON EXAMINATION AND MEAN ATRIAL PRESSURES (MAPS) WERE AROUND 80 MMHG. THERE WAS NO EVIDENCE OF ARRHYTHMIAS ON CONTINUOUS CARDIAC MONITORING, NOR RIGHT VENTRICULAR DYSFUNCTION ON TRANSTHORACIC ECHOCARDIOGRAM (TTE). CARDIAC COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) REVEALED FOCAL NARROWING OF THE LVAD OUTFLOW GRAFT CAUSED BY KINKING AND AN ECCENTRIC THROMBUS. THE PATIENT SUCCESSFULLY UNDERWENT STENTING OF THE LVAD OUTFLOW GRAFT OBSTRUCTION AND A PUMP EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    959328 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male