BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 5102968 · Received September 24, 2015

    Report

    Report Number
    2916596-2015-01752
    Event Type
    Injury
    Date Received
    September 24, 2015
    Date of Event
    August 12, 2015
    Report Date
    August 27, 2015
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT OF SUSPECTED THROMBUS CAN BE CONFIRMED BASED ON THE EVALUATION OF (B)(4). UPON DISASSEMBLY OF THE RETURNED PUMP, EXAMINATION OF THE BLOOD TUBE/ROTOR INLET SECTION REVEALED A PARTIAL THROMBUS RING ADHERED TO THE INLET BEARING BALL. THE THROMBUS RING APPEARED TO BE IN THE EARLY STAGES OF LAMINATED LAYERING, WHICH INDICATES IT DEVELOPED OVER AN UNDETERMINED AMOUNT OF TIME WHILE THE PUMP WAS OPERATING. EXAMINATION OF THE OUTLET STATOR REVEALED A NON-LAMINATED DEPOSITION SITUATED IN BETWEEN OUTLET BEARING BALL AND THE STATOR BLADES. THE LACK OF LAMINATED LAYERING INDICATES THAT THE DEPOSITION DID NOT DEVELOP IN THE OUTLET STATOR. ALTHOUGH ITS ORIGINS AND A DURATION OF TIME FOR WHICH IT WAS PRESENT IN THE OUTLET STATOR CANNOT BE CONCLUSIVELY DETERMINED, THE DEPOSITION DID NOT APPEAR DENATURED AND THE LACK OF CONTACT MARKS ON THE OUTLET BEARING CUP SUGGESTS THAT THE DEPOSITION WAS NOT LIKELY PRESENT IN THE OUTLET STATOR WHILE THE PUMP WAS OPERATING. THE THROMBUS FORMATIONS FOUND IN THE PUMP WOULD HAVE CONTRIBUTED TO THE CLINICAL SIGNS OF HEMOLYSIS. EXAMINATION OF THE PUMP BEARINGS, ROTOR, AND BLOOD-CONTACTING SURFACES UNDER A MICROSCOPE, REVEALED NO ABNORMALITIES THAT WOULD HAVE CONTRIBUTED TO THE FORMATION OF THE THROMBUS. THE PUMP UNDERWENT CLEANING, REASSEMBLY AND FUNCTIONAL TESTING UNDER LOADED CONDITIONS USING A MOCK CIRCULATORY LOOP. THE RETRIEVED DATA REVEALED NORMAL PUMP POWER CONSUMPTION COMPARABLE TO THE PUMP POWER CONSUMPTION RECORDED DURING THE MANUFACTURING PROCESS. THE PUMP OPERATED AS INTENDED. 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

    DEVICE WAS MANUFACTURED PRIOR TO THE UDI LABELING IMPLEMENTATION. APPROXIMATE AGE OF DEVICE: 1 YEAR. THE DEVICE WAS RETURNED FOR INVESTIGATION. THE EVALUATION IS NOT YET COMPLETE. 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. THE PATIENT CALLED THE VAD CLINIC TO REPORT EXPERIENCING HEMATURIA THE WEEK PRIOR AND HAD CONSULTED A LOCAL UROLOGIST. A SCAN WAS PERFORMED TO EVALUATE FOR KIDNEY STONES AND THE RESULTS WERE WITHIN NORMAL LIMITS WITH NO EVIDENCE OF STONES. AT THE TIME OF THE CALL, THE PATIENT REPORTED EXPERIENCING MORE PROFOUND HEMATURIA; BRIGHT RED BLOOD WITHOUT DIFFICULTY VOIDING AND NO EVIDENCE OF CLOTS. THE PATIENT WAS ADVISED TO GO TO THE CLINIC FOR LABS AND AN RN VISIT. THE PATIENT'S INR WAS 2.0, LACTATE DEHYDROGENASE WAS 2720 U/L AND PLASMA FREE HEMOGLOBIN WAS 200 G/DL. THE PATIENT WAS ADMITTED AND STARTED ON A HEPARIN DRIP. IT WAS REPORTED THAT THE PATIENT UNDERWENT A PUMP EXCHANGE ON (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633796 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 106015

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R