BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA RP FLEX

    MDR report key: 23094972 · Received September 19, 2025

    Report

    Report Number
    1220648-2025-46604
    Event Type
    Injury
    Date Received
    September 19, 2025
    Date of Event
    August 20, 2025
    Report Date
    September 18, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    PYX
    UDI-DI
    00813502012811
    PMA / PMN Number
    P170011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A.6 IS UNKNOWN. THE IMPELLA DEVICE WAS DISCARDED BY THE CUSTOMER AND THEREFORE, AN EVALUATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF THE REPORTED FAILURE MODE HAS BEEN COMPLETED. HEMOLYSIS: THE DATA LOGS SHOW THAT ABOUT 38 MINUTES INTO THE CASE THERE IS A LARGE STEP UP IN MOTOR CURRENT (MC) WITH A DECREASE IN PUMP AND PURGE FLOWS. LYSIS SOLUTION WAS ADDED WHICH SEEMS TO RESOLVE THE ISSUE AFTER ABOUT 3 HOURS. MC AND FLOWS REMAIN STEADY FOR 17 HOURS WHILE THE PUMP IS KEPT IN. THERE ARE NO POSITIONING ALARMS NOTED. BASED ON THE CLINICAL DETAILS PROVIDED AND DATA LOG ANALYSIS, THE ROOT CAUSE OF THE HEMOLYSIS IS DUE TO BIOLOGICAL MATERIAL INGESTION. THROMBOSIS THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. DEVICE HISTORY REVIEW: THE DEVICE PASSED ALL THE POST STERILE INSPECTION CHECKS.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT A PATIENT ON BIPELLA SUPPORT DECOMPENSATED SIGNIFICANTLY OVERNIGHT. THE PATIENT WAS EXPERIENCING SIGNIFICANT HEMOLYSIS AND SUSPICION OF CLOT INGESTION. A DECISION WAS MADE TO REMOVE THE IMPELLA RP FLEX AND CANNULATED FOR VENO-ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PUMP CAN NOT BE SENT BACK. IT DID HOWEVER INGEST A CLOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1760725 IMPELLA RP FLEX TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP PYX ABIOMED, INC. IMPELLA RP FLEX 2025574572 00813502012811

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Male Required Intervention