BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA

    MDR report key: 7903201 · Received September 24, 2018

    Report

    Report Number
    2916596-2018-03984
    Event Type
    Death
    Date Received
    September 24, 2018
    Date of Event
    September 1, 2018
    Report Date
    February 5, 2019
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011224
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE EVALUATION OF THE RETURNED PORTION OF THE HEARTMATE II OUTFLOW GRAFT, LOT NUMBER 100843, CONFIRMED THE REPORT OF THROMBUS; HOWEVER, A DIRECT CORRELATION BETWEEN HEARTMATE II LVAS, SERIAL NUMBER (B)(4), AND THE REPORTED PATIENT OUTCOME COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. THE PUMP WAS NOT EXPLANTED AND NOT RETURNED FOR EVALUATION. TWO JARS WERE RETURNED FOR EVALUATION. THE FIRST JAR CONTAINED THE OUTFLOW GRAFT WITH APPROXIMATELY 3.5¿ OF GRAFT MATERIAL, THE OUTFLOW GRAFT BEND RELIEF HARDWARE, AND THE O-RING SEPARATELY. THE GRAFT MATERIAL WAS FREE OF DISTORTION SUCH AS TWISTING OR KINKING. EXAMINATION OF THE INTERIOR OF THE OUTFLOW GRAFT MATERIAL DID NOT REVEAL EVIDENCE OF DEVELOPED DEPOSITIONS OR THROMBUS FORMATIONS. THE INTERIOR, TEXTURED SURFACE OF THE GRAFT ATTACHMENT REVEALED NO DEPOSITIONS OR THROMBUS FORMATIONS. THE SECOND JAR CONTAINED THREE PIECES OF A THROMBUS FORMATION. THE SIMILARITY IN SIZE AND STRUCTURE OF THESE PIECES SUGGESTS THAT THEY ORIGINATED AS ONE RING-LIKE THROMBUS FORMATION. THE ACCOUNT COMMUNICATED THAT THE THROMBUS WAS FOUND IN THE OUTFLOW GRAFT; HOWEVER, A SPECIFIC ORIGIN AND LOCATION WHERE THE THROMBUS FORMED COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE THROMBUS FORMATION CONTAINED DARK RED AREAS CONSISTENT WITH DENATURATION, WHICH COULD INDICATE THAT IT WAS PRESENT IN THE BLOOD FLOW PATH WHILE THE PUMP WAS SUPPORTING THE PATIENT. ALTHOUGH A DIRECT CAUSE FOR THE DEVELOPMENT OF THE THROMBUS COULD NOT BE CONCLUSIVELY DETERMINED, IT COULD HAVE CONTRIBUTED TO THE REPORTED ELEVATION IN LDH. THE HEARTMATE II LVAS IFU LISTS DEVICE THROMBOSIS AND HEMOLYSIS AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED THE DEVICE MET APPLICABLE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE REFERENCED PUMP EXCHANGE WAS REPORTED UNDER MEDWATCH MFR REPORT# 2916596-2018-03704. APPROXIMATE AGE OF DEVICE: ONE MONTH. THE PATIENT REMAINS ONGOING WITH THE DEVICE. HOWEVER, THE REPLACED OUTFLOW GRAFT WAS RETURNED FOR ANALYSIS. EVALUATION IS NOT COMPLETE. NO ADDITIONAL INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS REPORTED BY THE VAD COORDINATOR ON (B)(4) 2018 THAT THE PATIENT EXPIRED ON (B)(6) 2018. THE CAUSE OF EXPIRATION WAS NOTED AS "WITHDRAWAL OF SUPPORT DUE TO PUMP THROMBOSIS".

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2018. THE PATIENT RECEIVED A PUMP EXCHANGE ON (B)(6) 2018. THE LACTATE DEHYDROGENASE HAD BEEN DRIFTING UP SINCE (B)(6) 2018 WHICH WAS 491 U/L, REACHING 1409 U/L ON (B)(6) 2018. PLASMA-FREE HEMOGLOBIN WAS ALSO SLIGHTLY ELEVATED. PATIENT WAS ON HEPARIN DRIP, ASA 81 MG DAILY AND COUMADIN 6MG DAILY. INR GOAL 2.5 TO 3. INR ON (B)(6) 2018 WAS 3.3. DUE TO SUSPICION OF THROMBUS IN THE OUTFLOW GRAFT, THE PATIENT WAS RETURNED TO THE OPERATING ROOM WHERE THE OUTFLOW GRAFT WAS REPLACED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743714 HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA LEFT VENTRICULAR ASSIST SYSTEM DSQ THORATEC CORPORATION 106015 6337548 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death| H| R