BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RP FLEX W SMART ASSIST SET, US

    MDR report key: 24521528 · Received March 5, 2026

    Report

    Report Number
    1220648-2026-04555
    Event Type
    Malfunction
    Date Received
    March 5, 2026
    Date of Event
    December 17, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    PYX
    UDI-DI
    00813502012811
    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

    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

    A 68-YEAR-OLD MALE WITH END-STAGE HEART FAILURE UNDERWENT LEFT VENTRICULAR ASSIST DEVICE (LVAD) IMPLANTATION. HIS POSTOPERATIVE COURSE WAS COMPLICATED BY RIGHT VENTRICULAR FAILURE, AND HE WAS INITIATED ON VENO-VENOUS EXTRACORPOREAL MEMBRANE OXYGENATION (VV-ECMO) FOR TEMPORARY SUPPORT. DUE TO PERSISTENT RV DYSFUNCTION, A MULTIDISCIPLINARY HEART TEAM ELECTED TO IMPLANT AN IMPELLA RP FLEX FOR RIGHT-SIDED MECHANICAL CIRCULATORY SUPPORT. FIRST IMPELLA RP FLEX IMPLANT ATTEMPT: A RIGHT INTERNAL JUGULAR (RIJ) APPROACH WAS USED FOR DEVICE IMPLANTATION. HOWEVER, THE IMPELLA RP FLEX COULD NOT BE ADVANCED INTO THE OPTIMAL POSITION. THE INLET REMAINED OUTSIDE THE RIGHT VENTRICLE, AND THE OUTLET COULD NOT BE POSITIONED APPROPRIATELY WITHIN THE PULMONARY ARTERY. BECAUSE CORRECT POSITIONING COULD NOT BE ACHIEVED, THE DEVICE WAS REMOVED, AND THE TEAM ELECTED TO ATTEMPT RE-IMPLANTATION. A SECOND IMPELLA RP FLEX WAS SUCCESSFULLY IMPLANTED VIA THE RIJ, ACHIEVING THE APPROPRIATE RIGHT VENTRICULAR AND PULMONARY ARTERY POSITIONING. FOLLOWING SUCCESSFUL IMPLANTATION HEMODYNAMICS IMPROVED, AND THE PATIENT WAS ABLE TO WEAN FROM VV-ECMO, INDICATING IMPROVED RIGHT VENTRICULAR FUNCTION. AFTER 8 DAYS OF IMPELLA RP FLEX SUPPORT THE PURGE PRESSURE INCREASED, PROMPTING EVALUATION OF THE PURGE SYSTEM. THE PURGE SOLUTION WAS CHANGED FROM SODIUM BICARBONATE TO HEPARIN. THROUGHOUT THIS EVENT THE MOTOR CURRENT REMAINED UNCHANGED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE, AND NO PUMP ALARMS OR SIGNS OF DEVICE MALFUNCTION WERE REPORTED. GIVEN THE STABLE CONDITION AND VENTRICULAR RECOVERY, THE IMPELLA RP FLEX WAS REMOVED THE SAME DAY. THE PATIENT REMAINED HEMODYNAMICALLY STABLE FOLLOWING EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584301 RP FLEX W SMART ASSIST SET, US TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP PYX ABIOMED, INC. - 1220648 2026719883 00813502012811

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male