BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA RP

    MDR report key: 20540683 · Received October 26, 2024

    Report

    Report Number
    1220648-2024-21248
    Event Type
    Death
    Date Received
    October 26, 2024
    Date of Event
    August 15, 2021
    Report Date
    October 26, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    PYX
    UDI-DI
    00813502011029
    PMA / PMN Number
    P170011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION INTO THE HIGH PURGE PRESSURE ISSUE HAS BEEN COMPLETED. THE IMPELLA RP WAS NOT RECEIVED FROM THE CUSTOMER. THEREFORE, AN EVALUATION OF THE DEVICE WAS NOT POSSIBLE. THE DATA ANALYSIS OF THE LOGS CONFIRMED A SUDDEN RISE IN MOTOR CURRENT, PLACEMENT SIGNAL, AND PURGE PRESSURE. THE DATA WAS CONSISTENT WITH BIOMATERIAL BEING INGESTED INTO THE PUMP. THE ROOT CAUSE OF THE SPIKE IN MOTOR CURRENT AND HIGH PURGE PRESSURE WAS MOST LIKELY INGESTED BIOMATERIAL RESULTING FROM THE PATIENT ANATOMY. AS NOTED IN THE IMPELLA INSTRUCTIONS FOR USE: IMPELLA RP WITH SMARTASSIST SYSTEM SECTION: USING THE AUTOMATED IMPELLA CONTROLLER WITH THE IMPELLA RP WITH SMARTASSIST SYSTEM CATHETER ¿UNRESOLVED PURGE PRESSURE HIGH ALARM IF NOT RESOLVED BY THE RECOMMENDATIONS PROVIDED, HIGH PURGE PRESSURE¿WHICH TRIGGERS THE ¿PURGE PRESSURE HIGH¿ ALARM MESSAGE¿COULD BE AN INDICATION OF A KINK IN THE IMPELLA RP WITH SMARTASSIST SYSTEM CATHETER. IN THIS CASE, THE MOTOR IS NO LONGER BEING PURGED AND MAY EVENTUALLY STOP. MONITOR MOTOR CURRENT AND CONSIDER REPLACING THE IMPELLA RP WITH SMARTASSIST SYSTEM CATHETER WHENEVER A RISE IN MOTOR CURRENT IS SEEN.¿ THIS REPORT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF HISTORICAL RECORDS.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED A PATIENT POST CARDIOTOMY CARDIOGENIC SHOCK/LOW CARDIAC OUTPUT SYNDROME WAS IMPLANTED WITH AN IMPELLA RP FOR MECHANICAL CIRCULATORY SUPPORT. REPORTEDLY, THE PUMP WAS INDEPENDENTLY PLACED WITH PHONE SUPPORT ASSISTANCE FROM THE LOCAL TEAM AND THE CLINICIAN IN ROUTE TO ASSIST. IT WAS REPORTED DURING PLACEMENT OF A DIALYSIS CATHETER, THERE WAS AN ABRUPT RISE IN THE MOTOR CURRENT FROM APPROXIMATELY 350 MILLIAMPS (MA) TO 580 MA AND AN ABRUPT RISE IN PURGE PRESSURE FROM 40S TO 160S. ALSO, A SUDDEN DROP IN PURGE FLOW FROM ABOUT 30 TO 18. THE FAMILY DECLINED TO HAVE THE IMPELLA RP REPLACED. THE PATIENT WAS ON VENOARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION, THROMBOLYTIC THERAPY (SYSTEMIC OR IN PURGE) AND THE PATIENTS ACTIVATED CLOTTING TIME (ACT) WAS 207 SECONDS AT THE TIME OF THE OCCURRENCE. ADDITIONALLY, IT WAS NOTED THE SHEATH HAD BEEN INDWELLING SINCE PLACEMENT ON (B)(6) 2021. THE PLAN WAS FOR THE PATIENT TO CONTINUE WITH THERAPY, HOWEVER ON (B)(6) 2021, THE FAMILY MADE THE DECISION TO WITHDRAW CARE AND THE PATIENT EXPIRED. ADDITIONAL INFORMATION FROM THE FIELD REP NOTED THAT THE MOTOR CURRENT, PLACEMENT SIGNAL, AND PURGE PRESSURE ALL SUDDENLY ROSE WHILE THE PHYSICIAN WAS PLACING A FEMORAL VENOUS DIALYSIS CATHETER. THE TEAM HAD ALSO BEEN ATTEMPTING LEFT INTERNAL JUGULAR VEIN (LT IJ) ACCESS A FEW MOMENTS EARLIER. DESPITE THE PATIENT'S ACT BEING OVER 200 SECONDS, IT WAS REPORTED THAT THERE WERE CLOTS PRESENT ON THE GUIDEWIRE DURING THE IJ ACCESS ATTEMPT. THE HEPARIN INDUCED THROMBOCYTOPENIA (HIT) PANEL WAS NEGATIVE. THE PATIENT HAD BEEN FEBRILE OVER 39 DEGREES CELSIUS. CULTURES WERE PENDING. AT THE TIME OF THE EVENT, THE PURGE SOLUTION WAS DEXTROSE 5 PERCENTIN WATER WITH 25 UNITS OF HEPARIN/MILLILITER (ML). UPON RECOMMENDATION FROM THE FIELD REPRESENTATIVE, THE TEAM CONVERTED IT TO 50 UNITS OF HEPARIN/ML. A STEADY DROP IN MOTOR CURRENT AND PURGE PRESSURE TOWARDS PREVIOUS LEVELS WAS THEN NOTED. IT WAS ASSUMED THAT THE IMPELLA FLOW DISPLAY WAS INACCURATE BECAUSE OF THE PULSATILITY CHANGE IN THE PLACEMENT SIGNAL. PA PRESSURES WERE THE SAME AND LEFT-SIDED SUPPORT WAS UNCHANGED. NO OTHER TROUBLESHOOTING ATTEMPTS WERE MADE AS THE FAMILY HAD REFUSED ANY FURTHER MEASURES. CARE WAS WITHDRAWN ABOUT SIX HOURS LATER. THERE IS NOT ENOUGH INFORMATION TO EXCLUDE THE IMPELLA DEVICE AS AN ASSOCIATED FACTOR IN THE PATIENT'S DEMISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1796155 IMPELLA RP TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP PYX ABIOMED, INC. IMPELLA RP 2022049590 00813502011029

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Death