BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 4121254 · Received September 23, 2014

    Report

    Report Number
    2916596-2014-01699
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    August 23, 2014
    Report Date
    August 25, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER IS ATTEMPTING TO ACQUIRE THE DEVICE FOR FURTHER EVAL. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THROMBUS WAS CONFIRMED THROUGH THE EVALUATION OF THE RETURNED HEARTMATE II LVAD. THE EXAMINATION OF PUMP UPON DISASSEMBLY REVEALED A DEPOSITION SURROUNDING THE BEARING BALL WITHIN THE PROXIMAL SIDE OF THE OUTLET STATOR. THE DEPOSITION¿S LACK OF LAMINATED LAYERING INDICATES THAT IT DID NOT INITIALLY FORM IN THE OUTLET STATOR. THE DEPOSITION¿S AREAS OF DENATURATION ADJACENT TO THE BEARING BALL, AS WELL AS THE CONTACT MARKS OBSERVED AT THE DISTAL END OF THE ROTOR, SUGGEST THAT IT WAS PRESENT WHILE THE PUMP WAS SUPPORTING THE PATIENT. THE OBSERVED DEPOSITION COULD HAVE CONTRIBUTED TO THE PATIENT¿S HEMOLYSIS. UPON REMOVAL OF THE OBSERVED DEPOSITION, THE DEVICE WAS CLEANED. THE DISASSEMBLED PUMP¿S BEARINGS, ROTOR, AND BLOOD-CONTACTING SURFACES WERE THEN EXAMINED UNDER A MICROSCOPE AND NO ANOMALIES WERE OBSERVED. ELECTRICAL CONTINUITY TESTING OF THE DRIVELINE DID NOT REVEAL ANY DISCONTINUITIES OR SHORTS. THE PUMP WAS REASSEMBLED AND FUNCTIONALLY TESTED UNDER NORMAL OPERATING CONDITIONS USING A MOCK CIRCULATORY LOOP AND WAS FOUND TO FUNCTION AS INTENDED. A REVIEW OF DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PATIENT RECEIVED A HEART TRANSPLANT ON (B)(6) 2014. THE PT HAD EXPERIENCED HEMOLYSIS. ADD'L INFO WAS REQUESTED BUT SPECIFIC DETAILS WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591205 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 106015 133347

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention