BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE OUTFLOW GRAFT

    MDR report key: 3875004 · Received June 2, 2014

    Report

    Report Number
    2916596-2014-00880
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    April 24, 2014
    Report Date
    May 2, 2014
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: BASED ON THE INFORMATION PROVIDED TO THE MANUFACTURER, ONLY THE PUMP WAS EXCHANGED ON (B)(6) 2014 USING A SUBCOSTAL APPROACH (REFERENCE MEDWATCH # 2916596-2014-00881). THE OUTFLOW GRAFT BEND RELIEF REMAINED IN THE PATIENT SECURED BY A BEND RELIEF COLLAR THAT WAS APPLIED DURING THE REOPERATION ON (B)(6) 2014. THE REPORTED OUTFLOW GRAFT BEND RELIEF DISCONNECT WAS CONFIRMED BASED ON THE SUBMITTED CT IMAGES; HOWEVER, A ROOT CAUSE FOR THE DISENGAGEMENT OF THE SEALED OUTFLOW GRAFT BEND RELIEF AND THE SPECIFIC TIME AT WHICH IT OCCURRED COULD NOT BE DETERMINED. IT WAS COMMUNICATED THAT THE PATIENT HAS EXPERIENCED NO FURTHER ISSUES RELATED TO AN OUTFLOW GRAFT BEND RELIEF DISCONNECTION. 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.

    Additional Manufacturer Narrative · 1

    CONSEQUENTLY, THE PT ENDED UP RECEIVING AN EMERGENT PUMP EXCHANGE (B)(6) 2014 (REFERENCED ON MEDWATCH #0002916596-2014-00881). NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE USER FACILITY MEDWATCH REPORT WAS RECEIVED FROM THE (B)(4) REGISTRY. THE USER FACILITY NUMBER WAS NOT PROVIDED. (B)(4).

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PT INITIALLY PRESENTED TO THE CLINIC ON (B)(6) 2014 IN A WHEELCHAIR WITH A 6 LB WEIGHT GAIN, FATIGUE, GENERALIZED PAIN, AND AN LDH OF 600 (USUALLY 200). AN ECHO RAMP STUDY WAS UNREMARKABLE. THE PT WAS STARTED ON DIURETICS AND REPORTED TO BE "FEELING BETTER." A PRE-SCHEDULED 6 MONTH F/U CT FOR PULMONARY NODULES WAS LATER PERFORMED WHICH FOUND A DISCONNECTED PUMP SEALED OUTFLOW GRAFT BEND RELIEF. THE PT WAS ADMITTED TO THE HOSPITAL FOR REATTACHMENT OF THE BEND RELIEF. HEPARIN WAS STARTED BRIEFLY FOR AN INR OF 1.5 THEN STOPPED IN ANTICIPATION OF SURGERY. THREE ISOLATED INCIDENTS OF BRIEF PUMP POWER ELEVATIONS WERE NOTED ON THE HISTORY; THERE WERE NO OTHER ABNORMAL PARAMETERS. DURING SURGERY ON (B)(6) 2014, A LARGE AMOUNT OF ADHESIONS WERE ENCOUNTERED. THE LVAD WAS STOPPED FOR 36 MINS DURING THE BEND RELIEF ATTACHMENT. TWO SMALL HOLES THAT WERE FOUND IN THE OUTFLOW GRAFT WERE REPAIRED BY THE SURGEON. VAD PARAMETERS WERE WITHIN LIMITS AT THE END OF THE CASE. CT SCAN SHOWED GOOD POSITION OF THE OUTFLOW GRAFT WITH THE COLLAR INTACT. THE PT LDH WAS RISING. ECHO RAMP STUDY SHOWS LEFT VENTRICLE IS UNLOADING. THE PT WAS BEING TREATED MEDICALLY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE (B)(4) REGISTRY STATING: TRANSFERRED FROM LGH TO UNIV OF PENN WITH PUMP THROMBOSIS SUSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322499 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE OUTFLOW GRAFT DSQ: LEFT VENTRICULAR ASSIST DEVICE OUTFLOW GRAFT DSQ THORATEC CORPORATION 103393 12333

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention