BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 8858499 · Received August 4, 2019

    Report

    Report Number
    2916596-2019-03589
    Event Type
    Death
    Date Received
    August 4, 2019
    Date of Event
    July 12, 2019
    Report Date
    December 26, 2019
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INCIDENTAL FINDING DISCOVERED DURING THE EVALUATION OF THE HEARTMATE 3 LVAS. THE EVALUATION OF THE RETURNED CUFF LOCK REVEALED THAT THE TWO LOCKING ARMS WERE DEFORMED, WHICH IS CONSISTENT WITH THE PRIOR REPORT OF DIFFICULTY ENGAGING THE CUFF LOCK USING THE MINI APICAL CUFF AND MAKING A FORCEFUL ATTACHMENT DURING IMPLANT CAPTURED UNDER MFR #2916596-2019-03533. THE DEFORMED LOCKING ARMS DID NOT AFFECT THE LOCKING ABILITY OF THE CUFF LOCK WHEN ATTACHED TO A TEST MINI APICAL CUFF. MANUFACTURER'S INVESTIGATION CONCLUSION: THE EVALUATION OF THE RETURNED DEVICE DID NOT CONFIRM THE REPORT OF SUSPECTED PUMP THROMBOSIS. MOREOVER, A DIRECT CORRELATION BETWEEN THE DEVICE AND THE REPORTED STROKE AND PATIENT OUTCOME COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. UPON DISASSEMBLY OF THE RETURNED DEVICE, VISUAL EXAMINATION OF THE PUMP'S BLOOD-CONTACTING SURFACES REVEALED THE PRESENCE OF SOFT, RED ACCUMULATIONS OF LOOSELY COAGULATED BLOOD. THE COAGULATED BLOOD OBSERVED WITHIN THE DEVICE SHOWED LITTLE STRUCTURE, SHOWED NO EVIDENCE OF LAMINATED LAYERING OR DENATURATION, AND WAS NOT ADHERED TO THE BLOOD-CONTACTING SURFACES. THE ACCUMULATIONS OF COAGULATED BLOOD APPEARED CONSISTENT WITH POST-MORTEM BLOOD REMAINING STAGNANT IN THE DEVICE AFTER SUPPORT WITH WITHDRAWN AND WOULD NOT HAVE CONTRIBUTED TO A FUNCTIONAL ISSUE. VISUAL INSPECTION OF THE BLOOD-CONTACTING SURFACES OF THE RETURNED PUMP FOUND NO DEVELOPED OR ADHERED DEPOSITIONS OR THROMBUS FORMATIONS. VISUAL INSPECTION OF THE PUMP ROTOR AND ROTOR WELL REVEALED NO EVIDENCE OF DAMAGE. THE LVAD EVENT AND PERIODIC LOG FILES RETRIEVED FROM THE HEARTMATE 3 LVAS CUMULATIVELY CONTAINED DATA FROM THE IMPLANT DATE ON (B)(6) 2019 TO THE OUTCOME DATE ON (B)(6) 2019 AND APPEARED TO SHOW THE PUMP OPERATING AS INTENDED WITH STABLE PARAMETERS AND NO ATYPICAL EVENTS CAPTURED. FOLLOWING CLEANING, THE HEARTMATE 3 LVAS WAS REASSEMBLED AND OPERATED ON A MOCK CIRCULATORY LOOP. THE PUMP FUNCTIONED AS INTENDED AND IN ACCORDANCE WITH MANUFACTURING SPECIFICATIONS. THE HEARTMATE 3 LVAS IFU LISTS PUMP THROMBOSIS, VENOUS THROMBOEMBOLISM, HEMOLYSIS, STROKE, AND DEATH AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    APPROXIMATE AGE OF DEVICE - 16 DAYS. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2019. IT WAS REPORTED THAT THE PATIENT HAD A LARGE AMOUNT OF CALCIFIED THROMBUS IN THE LEFT VENTRICLE APEX AND ANTERIOR WALL PRIOR TO LVAD PLACEMENT. INFLOW WAS PLACED IN THE POSTERIOR WALL. SHORTLY AFTER VAD WAS PLACED, THE PATIENTS URINE BECAME DARK BUT CLEARED. THIS HAPPENED A FEW TIMES POST IMPLANT. ON (B)(6) 2019, A CT SCAN SHOWED LEFT MCA AND RIGHT PARIETAL STROKE. LDH 1945, URINE DARK. VAD PARAMETERS SPEED 5300, FLOW 4.6, PI 3.6, PWR 3.7. ON (B)(6) 2019 NEUROLOGY CONSULTED. THE PHYSICIAN THINKS THAT THE THROMBUS FROM THE LEFT VENTRICLE WAS SUCKED INTO THE PUMP, HEMOLYZED, AND THE EMBOLUS WAS PUSHED OUT. ON (B)(6) 2019 THE FAMILY ELECTED TO WITHDRAW CARE AND THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652392 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524US 7025788 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Death| H| R