BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LFET VENTRICULAR ASSIST DEVICE

    MDR report key: 3841066 · Received May 14, 2014

    Report

    Report Number
    2916596-2014-00771
    Event Type
    Injury
    Date Received
    May 14, 2014
    Date of Event
    August 8, 2013
    Report Date
    April 14, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE REPORT OF SUSPECTED PUMP THROMBUS COULD NOT BE CONFIRMED THROUGH THIS EVALUATION, BECAUSE THE PUMP WAS NOT RETURNED. NO LOG FILES WERE AVAILABLE TO CONFIRM THE REPORTED LOW FLOW ALARM AND POWER ELEVATIONS. MOREOVER, A CORRELATION BETWEEN THE DEVICE AND THE REPORTED BACTEREMIA, DRIVELINE INFECTION, PUMP POCKET INFECTION, AND ATRIAL FIBRILLATION/FLUTTER COULD NOT BE DETERMINED THROUGH THIS EVALUATION. THE INSTRUCTIONS FOR USE LISTS DEVICE THROMBOSIS, LOCAL INFECTION, DRIVELINE INFECTION, PUMP POCKET INFECTION, AND CARDIAC ARRHYTHMIA AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. THE PUMP WAS DISCARDED FOLLOWING THE TRANSPLANT. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED THE DEVICE MET APPLICABLE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PATIENT WAS IMPLANTED AT ANOTHER HOSP AND WAS READMITTED FOR PUMP THROMBUS. PUMP THROMBUS WAS SUSPECTED AND THE PUMP EVENTUALLY "SHUT OFF." THE PUMP WAS DISCONNECTED FROM THE PT AND THE DRIVELINE WAS CUT AT THE EXIT SITE. THE PT WAS SUBSEQUENTLY TRANSPLANTED ON (B)(6) 2013.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION SUMMARY: IN MID-JULY THE PATIENT WAS ADMITTED TO AN OUTSIDE HOSPITAL AND WAS FOUND TO HAVE (B)(6) AND PUMP DRIVELINE AND POCKET INFECTIONS. ON (B)(6) 2015 THE PATIENT WAS TRANSFERRED TO THE IMPLANTING CENTER FOR SURGICAL MANAGEMENT OF THE INFECTIONS AND ASSESSMENT FOR TRANSPLANT. UPON ADMISSION, THE PATIENT WAS PAN-CULTURED AND IV CEFTRIAXONE WAS STARTED. A CHEST CT SHOWED POST-OP CHANGES AND MULTIPLE AIR-FLUID LEVELS. THE PATIENT UNDERWENT TWO WOUND "WASHOUT" ROCEDURES WITH VANCOMYCIN [STERNAL AND PUMP POCKET AREAS] AND A STERNAL DEBRIDEMENT WITH WOUND VAC PLACEMENT. HE WAS PLACED ON CEFTRIAXONE AND RIFAMPIN WAS ADDED LATER. ON (B)(6) 2013, THE PATIENT UNDERWENT COMPLETE OMENTAL FLAP RECONSTRUCTION OF THE OPEN CHEST WOUND (16 X 6 CM) WITH A SPLIT-THICKNESS SKIN GRAFT TAKEN FROM THE PATIENT'S RIGHT LEG. THE PATIENT CONTINUED TO HAVE AN ELEVATED WBC COUNT, BUT WAS AFEBRILE AND STABLE ON ANTIBIOTICS. WOUND CULTURE DATA, INCLUDING INTRAOPERATIVE LVAD EXPLORATION CULTURES, WERE NEGATIVE. HIS RECOVERY WAS COMPLICATED WITH THE ONSET OF ATRIAL FIBRILLATION/FLUTTER WITH A RAPID VENTRICULAR RESPONSE AND DEVELOPED HYPOTENSION WITH PRE-SYNCOPE. THE PATIENT WAS ALREADY ON AMIODARONE AND RECEIVED AN AMIODARONE IV BOLUS. THE PATIENT WAS ANTICOAGULATED AND UNDERWENT SUCCESSFUL CARDIOVERSION TO SINUS RHYTHM WHICH WAS MAINTAINED THROUGHOUT THE REMAINDER OF HIS HOSPITALIZATION. ON (B)(6) 2013, THE PATIENT WAS DISCHARGED TO HOME WITH CONTINUED LONG-TERM IV CEFTRIAXONE AND ORAL RIFAMPIN. POST-DISCHARGE THE PATIENT'S INRS WERE SUBTHERAPEUTIC ON COUMADIN AND BRIDGING WITH LOVENOX WAS INITIATED. ON (B)(6) 2013 THE PATIENT PRESENTED TO THE ER WITH A "LOW FLOW" ALARM AND NEW ONSET DIZZINESS FOR THE PREVIOUS 24 HOURS WHEN AMBULATING TO A CHAIR. THE PATIENT DENIED CHEST PAIN, REPORTED NO SHORTNESS OF BREATH AND DENIED FEVERS AT HOME. HE EXHIBITED CLINICAL SYMPTOMS OF CARDIOGENIC SHOCK WITH HYPOPERFUSION INCLUDING BEING DIAPHORETIC, CLAMMY, AND TACHPYNEIC. THE PATIENT'S INR ON ADMISSION WAS 1.4 AND HIS BLOOD PRESSURE BY DOPPLER WAS 65 MMHG. ACCORDING TO THE FAMILY AND PATIENT, THE ALARM HAD BEEN GOING OFF SINCE AROUND 4 OR 5 AM. THEY HAD BEEN UNABLE TO REACH THE VAD COORDINATORS AT THE LOCAL HOSPITAL SO THEY TRAVELED TO THE IMPLANTING CENTER AND PRESENTED AT 7:30 AM. A RED HEART ALARM WAS CONFIRMED BY THE VAD COORDINATOR, WHO ATTEMPTED TO REPLACE POWER AND CHANGE CONTROLLERS, WHICH WAS UNSUCCESSFUL. UPON DEVICE INTERROGATION THE ESTIMATED FLOWS WERE 0.0 AND THE PUMP POWER WAS ELEVATED. AFTER MULTIPLE INTERVENTIONS THE PUMP WAS EVENTUALLY RESTARTED. THE DRIVELINE WAS INTACT WITHOUT DAMAGE. THE PATIENT WAS ADMITTED TO THE CVICU. UPON ARRIVAL, THE PATIENT WAS IN NO DISTRESS. THE PUMP PARAMETERS WERE AS FOLLOWS: RPM 8200, FLOW +++, PULSATILITY INDEX LESS THAN 1.5 AND PUMP POWERS GREATER THAN 9 WATTS. AFTER A DOBUTAMINE INFUSION WAS STARTED, THE CLINICAL SYMPTOMS OF CARDIOGENIC SHOCK IMPROVED AND THE PATIENT DEMONSTRATED IMPROVED NATIVE CARDIAC OUTPUT/CARDIAC INDEX. A TRANSTHORACIC ECHOCARDIOGRAM REVEALED A DILATED AND MODERATELY HYPOKINETIC RIGHT VENTRICLE. LEFT VENTRICULAR FUNCTION WAS MODERATELY DEPRESSED WITH FLOW AT THE INFLOW AND OUTFLOW CANNULAE AT A LOW VELOCITY THAT DID NOT VARY SIGNIFICANTLY DURING THE CARDIAC CYCLE. THE AORTIC VALVE WAS OPENING WITH EACH SYSTOLE. ON (B)(6) 2013, THE PUMP WAS STOPPED AND THE DRIVELINE WAS CUT IN THE OR UNDER LOCAL ANESTHETIC. WITHOUT LVAD SUPPORT, THE PATIENT WAS DEPENDENT ON IV DOBUTAMINE. THE PATIENT WAS EVALUATED FOR TRANSPLANT CANDIDACY AND WAS DISCHARGED ON (B)(6) 2013, CONTINUING ON IV DOBUTAMINE, ANTIBIOTICS AND COUMADIN. THE PATIENT RECEIVED A HEART TRANSPLANT ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288016 HEARTMATE II LFET VENTRICULAR ASSIST DEVICE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 122037

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention