BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)

    MDR report key: 10683634 · Received October 15, 2020

    Report

    Report Number
    2916596-2020-05002
    Event Type
    Injury
    Date Received
    October 15, 2020
    Date of Event
    September 20, 2020
    Report Date
    May 14, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011224
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: EVALUATION OF THE SUBMITTED LOG FILES CONFIRMED THE REPORTED POWER AND FLOW ELEVATIONS. THE REPORT OF SUSPECTED THROMBUS COULD NOT BE CONFIRMED THROUGH THIS EVALUATION. A DIRECT CORRELATION BETWEEN HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6), AND THE REPORTED GASTROINTESTINAL (GI) BLEEDING, POWER AND FLOW ELEVATIONS, AND SUSPECTED THROMBUS COULD NOT BE CONCLUSIVELY ESTABLISHED. THE SUBMITTED LOG FILES CONTAINED DATA FROM (B)(6). SEVERAL TRANSIENT ELEVATIONS IN PUMP POWER AND FLOW WERE CAPTURED THROUGHOUT THE DATA. THE PUMP SPEED REMAINED ABOVE THE LOW SPEED LIMIT, AND THE SYSTEM APPEARED TO BE OPERATING AS INTENDED. THE PATIENT REMAINS ONGOING ON HEARTMATE II LVAS, SERIAL NUMBER (B)(6), AND NO FURTHER RELATED COMPLAINTS HAVE BEEN REPORTED AT THIS TIME. THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), REV. C, LISTS BLEEDING AND DEVICE THROMBOSIS AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. SECTION 6 ENTITLED ¿PATIENT CARE AND MANAGEMENT¿ OUTLINES INDICATIONS OF PUMP THROMBOSIS, AS WELL AS HOW TO RESPOND TO SUCH EVENTS. SECTION 6 ALSO PROVIDES INFORMATION REGARDING ANTICOAGULATION THERAPY AND THE RECOMMENDED INR RANGE. SECTION 1 OF THE IFU ADDRESSES ALL PUMP PARAMETERS INCLUDING PUMP SPEED, POWER, FLOW, AND PULSATILITY INDEX (PI). IN REFERENCE TO POWER, THIS SECTION EXPLAINS THAT PUMP POWER IS A DIRECT MEASUREMENT OF MOTOR VOLTAGE AND CURRENT; THEREFORE, CHANGES IN PUMP SPEED, FLOW, OR PHYSIOLOGICAL DEMAND CAN AFFECT PUMP POWER. SECTION 4 EXPLAINS THAT IF THE SYSTEM DETECTS A PI EVENT, THE PUMP SPEED WILL AUTOMATICALLY REDUCE TO THE LOW SPEED LIMIT AND SLOWLY RAMP BACK UP TO THE FIXED SPEED SETPOINT. PI EVENTS ARE ASSUMED BY THE SYSTEM DURING CASES WHERE THERE IS A SUDDEN AND SUBSTANTIAL CHANGE IN PI. SOME REASONS FOR PI CHANGES INCLUDE SUDDEN CHANGES IN THE PATIENT¿S VOLUME STATUS, ARRHYTHMIAS, SUDDEN CHANGES IN POWER, AND SUDDEN CHANGES IN PUMP SPEED. THE HEARTMATE II LVAS PATIENT HANDBOOK, REV. C, SECTION 5 ENTITLED ¿ALARMS AND TROUBLESHOOTING¿ OUTLINES ALL SYSTEM CONTROLLER ALARMS AND PROVIDES INFORMATION REGARDING HOW TO RESPOND TO AND TROUBLESHOOT THE ALARMS. IN ADDITION, THE SLEEPING SECTION OF THE PATIENT HANDBOOK EXPLAINS THAT HEARTMATE II PATIENTS MUST BE ATTACHED TO THE POWER MODULE DURING SLEEP OR ANY TIME WHEN SLEEP IS LIKELY. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT GASTROINTESTINAL BLEEDING WAS NOT CONFIRMED. THE DEVICE OPERATED AS EXPECTED. THE PATIENT WAS GIVEN HEMOGLOBIN WITH 4 UNITS PACKED RED BLOOD CELLS (PRBC). THE PATIENT WAS OFF ANTICOAGULATION SINCE ADMISSION ON (B)(6) 2020, AT WHICH TIME INR WAS 1.7. PATIENT WAS ASYMPTOMATIC FOR POTENTIAL PUMP THROMBOSIS WITH NO DARK URINE. LACTATE DEHYDROGENASE (LDH) WAS 175 U/L ON (B)(6) 2020 AND 204 U/L ON (B)(6) 2020. HEMOGLOBIN (HGB) WAS 7.8 G/DL ON (B)(6) 2020.

    Description of Event or Problem · 1

    THE PATIENT WAS ADMITTED DUE TO RECURRENT GASTROINTESTINAL BLEEDING. ON (B)(6) 2020, THE PATIENT HAD A ISCHEMIC BOWEL WITH EMERGENT HEMICOLECTOMY. DURING THE CURRENT ADMISSION, THE PATIENT RECEIVED 4 UNITS OF PRBC. THE SITE EXPRESSED CONCERN FOR PUMP THROMBOSIS OR PUMP INGESTION. LOG FILE ANALYSIS CONFIRMED AN INCREASE IN POWER AND DECREASE IN PI EVENTS. NO FURTHER INFORMATION WAS REPORTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1146882 HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS) VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106015 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization