BEUDAMED
    FDA Adverse Event Death Summary report: N

    RP FLEX W SMART ASSIST SET, US

    MDR report key: 24523889 · Received March 5, 2026

    Report

    Report Number
    1220648-2026-04569
    Event Type
    Death
    Date Received
    March 5, 2026
    Date of Event
    December 23, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    PYX
    UDI-DI
    00813502012811
    PMA / PMN Number
    P170011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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.

    Additional Manufacturer Narrative · 0

    ADDED: D9 (DATE DEVICE RETURNED TO MANUFACTURER).

    Description of Event or Problem · 0

    A 63-YEAR-OLD MALE WITH ISCHEMIC CARDIOMYOPATHY (LVEF 10%), CORONARY ARTERY DISEASE, AND CHRONIC RENAL INSUFFICIENCY PRESENTED WITH BIVENTRICULAR CARDIOGENIC SHOCK. HE WAS INITIALLY MANAGED WITH INOTROPES AND VASOPRESSORS, BUT DEVELOPED PROGRESSIVE SHOCK. A MULTIDISCIPLINARY HEART TEAM ELECTED TO IMPLANT AN IMPELLA 5.5 FOR LEFT-SIDED MECHANICAL CIRCULATORY SUPPORT. AFTER 9 DAYS OF IMPELLA 5.5 SUPPORT, THE PATIENT DEVELOPED PROGRESSIVE RIGHT VENTRICULAR CARDIOGENIC SHOCK AND THE TEAM IMPLANTED AN IMPELLA RP FLEX TO ESTABLISH BIPELLA SUPPORT. HE REMAINED ON MECHANICAL VENTILATION AND WAS STARTED ON CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT). ON DAY 3 OF IMPELLA RP FLEX SUPPORT, THE AUTOMATED IMPELLA CONTROLLER (AIC) DISPLAYED ELEVATION IN THE PULMONARY ARTERY (PA) PLACEMENT SIGNAL WAVEFORM CONCURRENT DECREASE IN MOTOR CURRENT, AND DECREASE IN DISPLAYED PUMP FLOW, RAISING CONCERN FOR BIOMATERIAL INGESTION/INFLOW OBSTRUCTION. THE PA PLACEMENT SIGNAL WAVEFORM INTERMITTENTLY DISAPPEARED FROM THE AIC THEREAFTER. ADDITIONAL CONTEXT AT THE TIME OF THE CONSOLE FINDINGS WERE THAT THE PATIENT¿S SYSTEMIC ANTICOAGULATION WAS THERAPEUTIC AND CRRT WAS SIMULTANEOUSLY STOPPED DUE TO A CIRCUIT CLOT, SUGGESTING A PROTHROMBOTIC MILIEU. THE CARE TEAM WAS ADVISED TO USE ALTERNATIVE APPROVED DIAGNOSTIC DEVICES FOR ONGOING HEMODYNAMIC MONITORING. THERE IS NO REPORT OF PUMP STOPPAGE OR OTHER CONSOLE ALARMS. THE PATIENT REMAINED ON BIPELLA SUPPORT (IMPELLA 5.5 + IMPELLA RP FLEX), MECHANICAL VENTILATION, INOTROPES, AND VASOPRESSORS. AFTER A TOTAL OF 7 DAYS OF BIPELLA SUPPORT, THE FAMILY ELECTED TO WITHDRAW CARE. THE PATIENT SUBSEQUENTLY EXPIRED FOLLOWING WITHDRAWAL OF LIFE-SUSTAINING THERAPIES. DURING BIPELLA SUPPORT WITH 5.5 AND RP FLEX, ELEVATED PULMONARY ARTERY PLACEMENT SIGNAL (PAPS) WAVEFORM WAS NOT BEING DISPLAYED ON THE RP FLEX SCREEN. THIS INCREASE IN PAPS CORRELATED WITH A DECREASE IN MOTOR CURRENT AND PUMP FLOW; NO SPIKES WERE OBSERVED. ANTICOAGULATION THERAPEUTIC WAS NOTED IN THE COMPLAINT. ADDITIONALLY, THE OPTICAL SENSOR OF THE RP FLEX WENT OUT AND CAME BACK ON AND OFF DURING THE DURATION OF CARE. NO PATIENT CONSEQUENCE WAS NOTED IN REGARD TO THE OPTICAL SENSOR ISSUE. THIS IS CONSIDERED A REPORTABLE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207200 RP FLEX W SMART ASSIST SET, US TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP PYX ABIOMED, INC. - 1220648 2025590543 00813502012811

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Death