BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LVAS

    MDR report key: 4870271 · Received June 26, 2015

    Report

    Report Number
    2916596-2015-01159
    Event Type
    Malfunction
    Date Received
    June 26, 2015
    Date of Event
    December 8, 2014
    Report Date
    January 22, 2015
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    APPROXIMATE AGE OF DEVICE ¿ 5 DAYS. THE PUMP WAS RETURNED FOR EVALUATION. UPON DISASSEMBLY OF THE RETURNED PUMP, DEPOSITIONS OF TISSUE AND BLOOD WERE FOUND EXTENDING FROM THE LUMENS OF THE INLET TUBE, KNITTED GRAFT AND INLET ELBOW, THROUGHOUT THE PUMP, AND INTO THE LUMENS OF THE OUTLET ELBOW AND OUTFLOW GRAFT. THE AREAS OF THE DEPOSITIONS THAT WERE IN CONTACT WITH THE INLET AND OUTLET BEARINGS APPEARED SIGNIFICANTLY DENATURED. ALL OF THE DEPOSITIONS FOUND APPEARED TO HAVE BEEN EXPOSED TO A FIXATIVE AGENT PRIOR TO BEING RETURNED. DUE TO THIS, THE COMPOSITION OF THE THROMBUS COULD NOT BE CONCLUSIVELY DETERMINED. THE DEPOSITIONS APPEARED TO HAVE DEVELOPED DUE TO POOR SURFACE WASHING AS THE RESULT OF A LOW FLOW EVENT OR AN INTERRUPTION IN FLOW THROUGH THE PUMP; HOWEVER, A SPECIFIC CAUSE FOR THE INTERRUPTION IN FLOW COULD NOT BE CONCLUSIVELY DETERMINED. 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. PLACEHOLDER.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2014. IT WAS REPORTED THAT THE PATIENT EXPIRED ON (B)(6) 2015 FROM SEPTIC SHOCK (UNKNOWN ORIGIN) AND RIGHT HEART FAILURE. THERE WERE NO REPORTS OF ANY LVAD ISSUES AND THE PUMP PARAMETERS WERE REPORTED TO BE WITHIN NORMAL LIMITS FOR THE PATIENT¿S CONDITION. THERE WERE NO SIGNS OF THROMBUS, AND ECHOCARDIOGRAPHY SHOWED THE LEFT VENTRICLE WAS UNLOADING APPROPRIATELY. THE PATIENT HAD A HISTORY OF PULMONARY HYPERTENSION, RESTRICTIVE PULMONARY DISEASE AND A PULMONARY VEIN ANGIOPLASTY FOR STENOSIS. DURING THE IMPLANT PROCEDURE A TRICUSPID RING WAS PLACED FOR MODERATE TRICUSPID REGURGITATION AND A PATENT FORAMEN OVALE WAS REPAIRED. AFTER PUMP PLACEMENT INFERIOR VENA CAVA BLEEDING WAS NOTED AND REPAIRED. THE PATIENT REQUIRED NITRIC OXIDE THERAPY. THE PATIENT¿S POST-OPERATIVE COURSE WAS COMPLICATED WITH RESPIRATORY EVENTS REQUIRING MULTIPLE RE-INTUBATIONS AND THE PATIENT DEVELOPED ADULT RESPIRATORY DISTRESS SYNDROME (ARDS). HE ALSO REQUIRED MULTIPLE VASOACTIVE INFUSIONS AND HAD DIFFICULTY MAINTAINING FLUID BALANCE REQUIRING CONTINUOUS VENO-VENOUS HEMOFILTRATION. THE PATIENT WAS IN THE ICU FOR OVER 2 MONTHS. A DECISION WAS MADE TO WITHDRAW LVAD SUPPORT THIS MORNING AND THE PATIENT EXPIRED A FEW MINUTES LATER. THE PUMP WAS RETURNED FOR EVALUATION, AND DURING THE ANALYSIS LOW FLOW RELATED THROMBUS WAS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416371 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 106015

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR