BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 12320826 · Received August 13, 2021

    Report

    Report Number
    2916596-2021-04370
    Event Type
    Death
    Date Received
    August 13, 2021
    Date of Event
    July 24, 2021
    Report Date
    November 12, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A SPECIFIC CAUSE FOR THE REPORTED EVENTS, AS WELL AS A DIRECT CORRELATION TO HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6), COULD NOT CONCLUSIVELY BE DETERMINED THROUGH THIS EVALUATION. EVALUATION OF (B)(6) REVEALED NO FUNCTIONAL ISSUES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENTS. (B)(6) WAS RETURNED WITH THE PUMP CABLE FULLY INTACT. THE SEALED OUTFLOW GRAFT AND GRAFT ATTACHMENT WERE RETURNED ATTACHED TO THE PUMP COVER OUTLET PORT. THE OUTFLOW GRAFT BEND RELIEF WAS RETURNED SECURED TO THE GRAFT ATTACHMENT. THE APICAL CUFF WAS RETURNED SECURED BY THE CUFF LOCK. UPON DISASSEMBLY OF THE RETURNED PUMP, VISUAL EXAMINATION OF THE PUMP¿S BLOOD-CONTACTING SURFACES REVEALED NO EVIDENCE OF ADHERED OR DEVELOPED DEPOSITIONS OR THROMBUS FORMATIONS THAT WOULD HAVE CONTRIBUTED TO A FUNCTIONAL ISSUE. VISUAL INSPECTION OF THE PUMP ROTOR AND ROTOR WELL DID NOT REVEAL ANY OBVIOUS SURFACE SCRATCHES OR DEFECTS. THE RETRIEVED CONTROLLER EVENT LOG FILE FROM THE RETURNED SYSTEM CONTROLLER CONTAINED DATA FROM (B)(6) 2021 AT 3:00:11 TO (B)(6) 2021 AT 8:55:39. ON (B)(6) 2021 AT 6:20:03 THE PUMP CALCULATED FLOW DROPPED BELOW THE LOW FLOW THRESHOLD OF 2.5 LPM. FROM 6:20:03 TO THE END OF THE CAPTURED DATA AT 8:52:09 THERE WERE CONTINUOUS LOW FLOW ALARMS, RESULTING IN 34 LOW FLOW FAULTS AND 33 LOW FLOW ALARMS. THE PUMP CALCULATED FLOW DURING THIS TIME WAS AS LOW AS 0 LPM. ALTHOUGH A SPECIFIC CAUSE FOR THE LOW FLOW ALARMS COULD NOT CONCLUSIVELY BE DETERMINED, THE TIME OF THESE EVENTS CORRESPOND TO THE PATIENT¿S DEATH. THE PUMP OPERATED AT THE SET SPEED FOR THE DURATION OF THE CAPTURED DATA. THE PUMP APPEARED TO OPERATE AS EXPECTED. (B)(6) WAS CLEANED, REBUILT, AND FUNCTIONALLY TESTED ON A MOCK CIRCULATORY LOOP. THE DEVICE OPERATED AS INTENDED AND IN ACCORDANCE WITH MANUFACTURING SPECIFICATIONS. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE LVAS KIT WAS SHIPPED ON 19FEB2020. THE HEARTMATE 3 LVAS INSTRUCTIONS FOR USE (IFU) AND PATIENT HANDBOOK ARE CURRENTLY AVAILABLE. SECTION 1 ENTITLED ¿INTRODUCTION¿ LISTS CARDIAC ARRHYTHMIA AND DEATH AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. SECTION 6 ENTITLED ¿PATIENT CARE AND MANAGEMENT¿ PROVIDES INFORMATION REGARDING ANTICOAGULATION, INCLUDING THE RECOMMENDED INTERNATIONAL NORMALIZED RATIO (INR). NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    THE PATIENT'S PACEMAKER HAD DELIVERED 2 ANTITACHYCARDIA PACING (ATP) AND 9 SHOCKS FOR VENTRICULAR FIBRILLATION AT THE TIME OF INCIDENT. THE ARRHYTHMIA WAS PRE-EXISTING AND THE IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (ICD) WAS IMPLANTED BEFORE THE PUMP.

    Additional Manufacturer Narrative · 1

    (B)(6). NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURERS INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELL ON 24JUL AS A RESULT OF LOSS OF CONSCIOUSNESS. THE PUMP DID NOT ALARM DURING FAINTING. THE FALL PRODUCED A BIG BRUISE ON THE PATIENT'S SIDE AND THE PATIENT'S SOUND WENT HOARSE. AFTER THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR X-RAY CONCERNING FOR FRACTURE AND THEN DISCHARGED, THE PATIENT WAS FOUND LIFELESS. THE DEVICE ALARMED FOR 130 MINUTES, BUT THE ALARM ITSELF WAS UNKNOWN. THE PUMP WAS TURNED OFF AFTER DEATH. AN AUTOPSY WILL BE PERFORMED AFTER WHICH THE PUMP WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1215817 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524INT 7368480

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Life Threatening| D