BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 4023438 · Received August 14, 2014

    Report

    Report Number
    2916596-2014-01429
    Event Type
    Injury
    Date Received
    August 14, 2014
    Date of Event
    July 15, 2014
    Report Date
    July 17, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND IS CURRENTLY BEING ANALYZED. 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

    ADDITIONAL INFORMATION: THE REPORT OF HEMOLYSIS AND THROMBUS WAS CONFIRMED BASED ON THE EVALUATION OF THE PUMP. EXAMINATION OF THE PUMP¿S BLOOD-CONTACTING SURFACES FOUND DENATURED RINGS OF TISSUE-LIKE THROMBUS ADHERED TO THE INLET BEARING CUP AND INLET BEARING BALL. THE RINGS APPEARED TO HAVE BEEN A SINGLE FORMATION THAT PULLED APART DURING THE PUMP DISASSEMBLY. THE TISSUE SHOWED LAMINATED LAYERING, INDICATING THAT THE RING FORMED OVER AN UNDETERMINED PERIOD OF TIME. THE EXAMINATION ALSO FOUND A DENATURED, TISSUE-LIKE THROMBUS IN ONE OF THE ROTOR VANES. A PORTION OF THE TISSUE APPEARED CURVED AND SHOWED LAMINATED LAYERS, SIMILAR TO THE INLET BEARING THROMBUS, INDICATING THAT THE ROTOR THROMBUS MAY HAVE INITIALLY BEEN PART OF THE INLET BEARING RING. IN ADDITION, EXAMINATION OF THE OUTLET STATOR FOUND RED, TISSUE-LIKE THROMBUS BETWEEN THE OUTLET BEARING AND THE STATOR BLADES, WHICH SHOWED SIMILAR COLOR AND TEXTURE TO THE INLET BEARING AND ROTOR THROMBI. ALTHOUGH THE EVALUATION COULD NOT DETERMINE THE SPECIFIC CAUSE FOR THE DEVELOPMENT OF THE THROMBI, ALL OF THE OBSERVED THROMBI WOULD HAVE CONTRIBUTED TO THE REPORTED HEMOLYSIS. VISUAL INSPECTION OF THE PUMP BEARINGS AND BEARING CUPS FOUND NO ANOMALIES. EXAMINATION OF THE RETURNED PORTION OF THE DRIVELINE FOUND IT TO BE UNREMARKABLE. ELECTRICAL CONTINUITY TESTING OF THE DRIVELINE DID NOT REVEAL ANY DISCONTINUITIES OR SHORTS. THE PUMP WAS REASSEMBLED AN OPERATED ON A MOCK CIRCULATORY LOOP AND FUNCTIONED 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 PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE PT WAS READMITTED FOR AN LDH OF 4000U/L AND DECLINING RENAL FUNCTION. THE PUMP WAS EXCHANGED ON (B)(6) 2014 FOR HEMOLYSIS. A CLOT WAS REPORTEDLY VISUALIZED BY THE SURGEON. THE PT REPORTEDLY TOLERATED THE PROCEDURE WELL.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION PROVIDED ON SEPTEMBER 10, 2014 INDICATED THAT THE PATIENT'S LACTATE DEHYDROGENASE WAS WITHIN NORMAL LIMITS. ADDITIONAL INFORMATION PROVIDED ON DECEMBER 11, 2014 INDICATED THAT PATIENT CONTINUED TO BE STABLE, NO SIGNS OF HEMOLYSIS SINCE PUMP EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488065 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 106015 138623

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention