BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, EU

    MDR report key: 8567603 · Received April 30, 2019

    Report

    Report Number
    2916596-2019-02093
    Event Type
    Injury
    Date Received
    April 30, 2019
    Date of Event
    April 11, 2019
    Report Date
    August 1, 2019
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D10: ADDITIONAL INFORMATION SECTION H3, H4: CORRECTION MANUFACTURER'S INVESTIGATION CONCLUSION: NO DEVICE-RELATED ISSUES WERE DISCOVERED DURING THE EVALUATION OF THE RETURNED PUMP. THE EVALUATION DID NOT CONFIRM THE REPORT OF A POTENTIAL PUMP OBSTRUCTION AND COULD NOT DETERMINE A SPECIFIC CAUSE FOR THE REPORTED INTERMITTENT ELEVATIONS IN PUMP POWER/ESTIMATED FLOW CONFIRMED VIA THE LOG FILE DOWNLOADED FROM THE RETURNED SYSTEM CONTROLLER. MOREOVER, A DIRECT CORRELATION BETWEEN THE RETURNED DEVICE AND THE REPORTED AORTIC INSUFFICIENCY COULD NOT BE CONCLUSIVELY DETERMINED. VISUAL INSPECTION OF THE SMOOTH AND TEXTURED BLOOD-CONTACTING SURFACES OF THE SEALED INFLOW CONDUIT AND THE SEALED OUTFLOW CONDUIT REVEALED NO EVIDENCE OF TISSUE-LIKE DEPOSITIONS OR THROMBUS FORMATIONS THAT WOULD HAVE CONTRIBUTED TO A FUNCTIONAL ISSUE. IN ADDITION, VISUAL EXAMINATION OF THE PUMP¿S BLOOD-CONTACTING SURFACES UPON DISASSEMBLY OF VAD-19073 REVEALED NO EVIDENCE OF DEPOSITIONS OR THROMBUS FORMATIONS. THE INFLOW GRAFT AND THE RETURNED PORTION OF THE OUTFLOW GRAFT SHOWED NO EVIDENCE OF TWISTING OR KINKING THAT MAY HAVE CONTRIBUTED TO A FLOW OBSTRUCTION DURING VAD SUPPORT. MICROSCOPIC INSPECTION OF THE PUMP BEARINGS, ROTOR, AND BLOOD-CONTACTING SURFACES DID NOT REVEAL ANY ANOMALIES. ELECTRICAL CONTINUITY TESTING OF THE RETURNED PORTION OF THE DRIVELINE DID NOT REVEAL ANY DISCONTINUITIES OR SHORTS. FUNCTIONAL TESTING OF (B)(4) UNDER NORMAL OPERATING CONDITIONS REVEALED NORMAL PUMP POWER CONSUMPTION AND PRESSURE VALUES THAT WERE WITHIN MANUFACTURING SPECIFICATION AND THE PUMP OPERATED AS INTENDED. THE HEARTMATE II LVAS IFU PROVIDES AN EXPLANATION OF EACH OF THE PUMP PARAMETERS (INCLUDING PUMP POWER AND FLOW) IN SECTIONS 1 "INTRODUCTION" AND 4 "SYSTEM MONITOR". NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    APPROXIMATE AGE OF DEVICE ~ 2 YEARS AND 2 MONTHS. 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 LEFT VENTRICULAR ASSIST DEVICE ON (B)(6) 2017. IT WAS REPORTED THAT THE PATIENT WAS ON ROUTINE VISIT AND HAD HIGH POWER AND HIGH LOW FLOW. PATIENT'S PUMP SPEED WAS 9400 RPM, FLOW AROUND 10 L/MN AND POWER 10W, WHICH INCREASES TIME TO TIME. PATIENT EXPERIENCED AORTIC INSUFFICIENCY. ON ECHOCARDIOGRAM, THE LEFT VENTRICLE IS DILATED (SINCE THE IMPLANTATION), THE CLINICAL STAFF WILL ORGANIZE A RAMP TEST FOR THIS PATIENT AND THEY ARE WAITING THE BIOLOGICAL DATA. THE VAD TEAM DECIDED TO PUT PATIENT ON EMERGENCY TRANSPLANT LIST DUE TO POTENTIAL PUMP OBSTRUCTION, AND THE PATIENT WAS TRANSPLANTED. PUMP WILL BE SHIPPED TO THE MANUFACTURER FOR EVALUATION. NO FURTHER INFORMATION IS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360884 HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, EU LEFT VENTRICULAR ASSIST SYSTEM DSQ THORATEC CORPORATION 106016 5765833

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R