BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 4203065 · Received October 23, 2014

    Report

    Report Number
    2916596-2014-01881
    Event Type
    Injury
    Date Received
    October 23, 2014
    Date of Event
    September 23, 2014
    Report Date
    September 24, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVALUATION OF THE RETURNED DEVICE CONFIRMED THE REPORT OF HEMOLYSIS AND SUSPECTED THROMBUS. EXAMINATION OF THE SEALED INFLOW CONDUIT AND OUTFLOW ELBOW SHOWED NO EVIDENCE OF DEPOSITION OR THROMBUS FORMATION. EXAMINATION OF THE BODY OF THE PUMP SHOWED A LARGE, FLAT THROMBUS SEATED ON THE BODY OF THE ROTOR. THE THROMBUS WAS SITUATED BETWEEN TWO OF THE ROTOR BLADES AND WAS OCCLUDING ONE OF THE ROTOR PATHWAYS. THE THROMBUS SHOWED NO EVIDENCE OF LAMINATION AND NO AREAS OF DENATURING. ALTHOUGH ITS STRUCTURE INDICATES THAT IT DID NOT ORIGINATE ON THE ROTOR, ITS SPECIFIC ORIGIN COULD NOT BE CONCLUSIVELY DETERMINED. IN ADDITION, ITS PRESENCE IN THE PUMP DURING OPERATING WOULD HAVE CONTRIBUTED TO THE REPORTED HEMOLYSIS. EXAMINATION OF THE PUMP BEARINGS, ROTOR, AND BLOOD CONTACTING SURFACES DID NOT REVEAL ANY ANOMALIES THAT WOULD HAVE CONTRIBUTED TO A FUNCTIONAL ISSUE. ELECTRICAL CONTINUITY TESTING OF THE DRIVELINE DID NOT REVEAL ANY DISCONTINUITIES OR SHORTS. FUNCTIONAL TESTING OF THE PUMP UNDER NORMAL OPERATING CONDITIONS REVEALED NORMAL PUMP POWER CONSUMPTION AND PRESSURE VALUES COMPARABLE TO THE DATA RECORDED DURING THE MANUFACTURING PROCESS. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED THAT THE DEVICE MET APPLICABLE SPECIFICATIONS. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EXPLANTED DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED THAT THE PATIENT RECEIVED A PUMP EXCHANGE DUE TO HEMOLYSIS AND SUSPECTED DEVICE THROMBOSIS. THE SURGEON STATED THAT HE DID NOT VISUALIZE THROMBUS WITHIN THE PUMP AND THAT IT MAY HAVE BEEN INGESTED CALCIUM RELATED TO HIS ANEURYSM.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM THE (B)(4) REGISTRY STATING: PATIENT HAD HM II IMPLANTED ON (B)(6) 2014. POST-OP WORSENING HEMOLYSIS. LDH (B)(6) =185, LDH (B)(6) =2147. INCREASED PUMP POWER, REDUCED OUTPUT, WORSENING RENAL INSUFFICIENCY, EMBOLIC CVA ON (B)(6) -CT CONFIRMED. SALVAGE LVAD REPLACEMENT ON (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675558 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 106015 145720

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention