BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA RP FLEX

    MDR report key: 23618534 · Received November 21, 2025

    Report

    Report Number
    1220648-2025-48547
    Event Type
    Death
    Date Received
    November 21, 2025
    Date of Event
    October 24, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    PYX
    UDI-DI
    00813502012811
    PMA / PMN Number
    P170011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER. THEREFORE, THE INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION/ANALYSIS OF THE DEVICE WAS NOT POSSIBLE. THE INVESTIGATION WAS COMPLETED AND NOTED A DEVICE HISTORY RECORD REVIEW CONFIRMED THE DEVICE PASSED ALL THE POST STERILE INSPECTION CHECKS. MAJOR BLEED: THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. PLACEMENT SIGNAL ISSUE: THE DATA LOGS CONFIRM PLACEMENT SIGNAL NOT RELIABLE ALARMS (#1051 AND #1053). THE LOGS SHOW A MOTOR CURRENT SPIKE DOWN WITH A SMALL SPEED DEVIATION SHORTLY BEFORE A GRADUAL DECREASE IN PLACEMENT SIGNAL WHILE PUMP FLOWS INCREASED. PUMP WAS AT P9. THE PLACEMENT SIGNAL DRIFT CONTINUED UNTIL PLACEMENT SIGNAL WENT OUT OF RANGE AND FLOW CALCULATION WAS LOST. IT IS UNKNOWN WHAT LED TO THE DOWNWARDS MOTOR CURRENT SPIKE AND SUBSEQUENT DRIFT. THE CAUSE OF THE ISSUE WAS UNABLE TO BE ESTABLISHED AS NO PRODUCT WAS RETURNED FOR ANALYSIS AND LOG ANALYSIS WAS NOT CONCLUSIVE. PURGE PRESSURE HIGH: THE DATA LOGS CONFIRM PURGE PRESSURE HIGH ALARMS AND SHOW A GRADUAL RISE IN PURGE PRESSURE OVER ABOUT AN HOUR WITH A DECREASE IN PURGE FLOWS. THERE WERE NO MOTOR CURRENT SPIKES OUTSIDE P-LEVEL CHANGES. CLINICAL MENTIONED SYSTEMIC HEPARIN WAS DELAYED DUE TO PATIENT'S BLEEDING. TPA WAS ADDED TO THE PURGE. ELEVATED PURGE PRESSURE REMAINED FOR ABOUT 3 HOURS BEFORE DECREASING TOWARDS NORMAL VALUES. THE CAUSE OF THE ISSUE WAS DETERMINED TO BE BIOMATERIAL BUILD UP AS EVIDENCED BY LOG ANALYSIS. H6 INVESTIGATION: TYPE, FINDINGS, AND CONCLUSION CODES AND H6 COMPONENT CODES WERE UPDATED ACCORDINGLY BASED ON THE COMPLETED INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT IMPLANTED WITH AN IMPELLA RP FLEX EXPERIENCED AN UNRELIABLE PLACEMENT SIGNAL AND ABSENCE OF FLOW CALCULATIONS. THE PATIENT HAD MEDIASTINAL BLEEDING AND BLEEDING FROM CHEST TUBES. THE PATIENT WAS TRANSFUSED THREE UNITS OF PACKED RED BLOOD CELLS, FRESH FROZEN PLASMA, PLATELETS, AND CYROPRECIPITATE. NEXT, THE PUMP DISPLAYED A HIGH PURGE PRESSURE ALARM. NO KINKS OR EXTERNAL CAUSES FOR THE ALARM WERE IDENTIFIED. THE PURGE CASSETTE WAS CHANGED BUT THE ALARM DID NOT RESOLVED. TISSUE PLASMINOGEN ACTIVATOR WAS ADDED TO THE PURGE, AND VASOPRESSORS WERE ADMINISTERED. SYSTEMIC HEPARIN WAS WITHHELD. THE DECISION WAS MADE TO WITHDRAW CARE AND THE PATIENT EXPIRED. ADDITIONAL INFORMATION WAS RECEIVED. THE PUMP WAS NOT RETAINED. THERE ARE TWO RELATED REPORTS. THIS REPORT REPRESENTS THE PUMP AND ANOTHER REPORTED WAS SUBMITTED TO REPRESENT THE AUTOMATED IMPELLA CONTROLLER. REFER TO SECTION H10 FOR THE RELATED REPORT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2117532 IMPELLA RP FLEX TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP PYX ABIOMED, INC. IMPELLA RP FLEX 2026764947 00813502012811

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention| D