BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS, EUROPE

    MDR report key: 3940331 · Received June 19, 2014

    Report

    Report Number
    2916596-2014-00967
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 22, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED ASSEMBLED WITH THE PERCUTANEOUS LEAD (LEAD) CUT APPROXIMATELY 3 INCHES FROM THE PUMP HOUSING AND THE REMAINDER OF THE LEAD WAS NOT RETURNED. NO DAMAGE TO THE SILICONE SLEEVE WAS OBSERVED. THE SILICONE SLEEVE WAS REMOVED AND ELECTRICAL CONTINUITY TESTING OF THE LEAD DID NOT REVEAL ANY DISCONTINUITIES OR SHORTS PRIOR TO REMOVING THE PLASTIC SHIELD (BIONATE). ONCE THE BIONATE WAS REMOVED, BREAKDOWN OF THE METAL SHIELD WAS SEEN CLOSE TO THE PUMP. THE METAL SHIELDING WAS REMOVED AND THE WIRES WERE VISUALLY INSPECTED UNDER A MICROSCOPE. ABRASION MARKS AND A BREACH AT APPROXIMATELY 2 INCHES FROM THE PUMP WERE IDENTIFIED ON THE YELLOW WIRE. THE DAMAGE APPEARED TO BE CONSISTENT WITH FATIGUE DAMAGE DUE TO REPETITIVE MOVEMENT OF THE WIRE AT THIS LOCATION. AS A RESULT OF THE DAMAGE, THE UNDERLYING YELLOW WIRE CONDUCTORS WERE EXPOSED. THE REPORTED RED HEART ALARMS WOULD HAVE OCCURRED AS A RESULT OF THE EXPOSED CONDUCTORS OF THE WIRE CONTACTING THE BRAIDED SHIELDING WHEN THE DEVICE WAS SUPPORTED BY A POWER MODULE. THE PUMP WAS CLEANED, REASSEMBLED, AND FUNCTIONALLY TESTED UNDER NORMAL OPERATING CONDITIONS USING A MOCK CIRCULATORY LOOP. THE DATA RETRIEVED FROM THAT TESTING REVEALED NORMAL PUMP POWER CONSUMPTION AND PRESSURE VALUES, COMPARABLE TO WHAT WAS RECORDED DURING THE MANUFACTURING PROCESS AND THE DEVICE FUNCTIONED AS INTENDED. THE PATIENT¿S SYSTEM CONTROLLER (SERIAL #(B)(4)) AND PATIENT CABLE (LOT # 35264980413) WERE RETURNED AND FUNCTIONALLY TESTED AND WERE FOUND TO FUNCTION AS INTENDED. THE PATIENT¿S EVENT HISTORY WAS RETRIEVED FROM THE RETURNED SYSTEM CONTROLLER AND THE REPORTED ALARMS WERE CONFIRMED. A REVIEW OF DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS THAT WOULD AFFECT DEVICE FUNCTION OR PERFORMANCE. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER IS ATTEMPTING TO ACQUIRE THE EXPLANTED PUMP FOR ANALYSIS. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED. APPROXIMATELY FIVE DAYS LATER THE MANUFACTURER'S TECHNICAL SERVICE PERSONNEL PERFORMED PERCUTANEOUS LEAD TESTING AND NO DAMAGE WAS SEEN. EVIDENCE OF BIO DEBRIS WAS SEEN BETWEEN THE BICORNATE AND SILICONE COVER OF THE PERCUTANEOUS LEAD. A PUMP EXCHANGE WAS RECOMMENDED FOR THE PT. ADDITIONAL INFO RECEIVED INDICATED THAT THE PT WAS TRANSPLANTED ON (B)(6) 2014.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). APPROXIMATELY 2.5 YEARS POST-IMPLANT, IT WAS REPORTED THAT THE PT EXPERIENCED A RED HEART ALARM AND WENT TO THE HOSPITAL. THE PHYSICIAN CONNECTED THE POWER MODULE TO THE SYSTEM CONTROLLER AND A RED HEART AND LOW SPEED ALARM OCCURRED. THE PHYSICIAN REPORTED THAT THE PUMP SPEED HAD DROPPED BELOW 3000 RPMS. THE PT WAS ADMITTED INTO THE HOSPITAL FOR OBSERVATION. APPROXIMATELY TWO DAYS LATER, TECHNICAL SERVICE PERSONNEL WENT TO THE HOSPITAL TO PERFORM TESTING. NO ALARMS WERE ABLE TO BE REPRODUCED AND NO DAMAGE WAS SEEN ON THE PERCUTANEOUS LEAD AND X-RAYS WERE PERFORMED. THE PT CABLE AND THE SYSTEM CONTROLLER WERE EXCHANGED AND THE HOSPITAL CONTINUED TO MONITOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360939 HEARTMATE II LVAS, EUROPE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104912 105500

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention