BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RP FLEX W SMART ASSIST SET, US

    MDR report key: 24518835 · Received March 5, 2026

    Report

    Report Number
    1220648-2026-04521
    Event Type
    Malfunction
    Date Received
    March 5, 2026
    Date of Event
    March 26, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    PYX
    UDI-DI
    00813502012811
    PMA / PMN Number
    P170011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ABIOMED INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ABIOMED INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT PLACEMENT SIGNALS WERE NOT RELIABLE. THE DEVICE INVOLVED WAS AN IMPELLA RP FLEX SYSTEM THAT HAD BEEN IMPLANTED FOR CIRCULATORY SUPPORT. THE PATIENT REMAINED ON SUPPORT DURING THE TIME OF THE REPORT, AND SURVIVAL OUTCOME AT EXPLANT WAS NOT YET DETERMINED. THE IMPELLA ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL VEIN USING A PERCUTANEOUS APPROACH. AT THE TIME OF THE EVENT, THE PATIENT CONTINUED TO RECEIVE SUPPORT, AND NO FINAL OUTCOME HAD BEEN DOCUMENTED. A PRODUCT RETURN WAS EXPECTED BUT HAD NOT BEEN CONFIRMED. NO PATIENT DEATH WAS ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582216 RP FLEX W SMART ASSIST SET, US TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP PYX ABIOMED, INC. - 1220648 2025564017 00813502012811

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female