BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA RP FLEX

    MDR report key: 23769263 · Received December 10, 2025

    Report

    Report Number
    1220648-2025-48901
    Event Type
    Death
    Date Received
    December 10, 2025
    Date of Event
    November 11, 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
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL SAFETY/CLINICAL REVIEWED THE EVENT. A 68-YEAR-OLD FEMALE PATIENT UNDERWENT ORTHOTOPIC HEART TRANSPLANTATION (OHT) ON (B)(6) 2025. EARLIER ON THE DAY OF THE REPORTED EVENT, THE PATIENT WAS DECANNULATED FROM EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). FOLLOWING DECANNULATION, THE PATIENT EXPERIENCED ACUTE HEMODYNAMIC DECOMPENSATION REQUIRING RIGHT VENTRICULAR MECHANICAL CIRCULATORY SUPPORT WITH AN IMPELLA RP FLEX DEVICE. THE PATIENT WAS CLASSIFIED AS SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY AND INTERVENTIONS (SCAI) STAGE E CARDIOGENIC SHOCK. DURING DEVICE PREPARATION AND PRIMING, A ¿PURGE PRESSURE LOW¿ CRITICAL ALARM WAS TRIGGERED. THE TEAM REPORTED THAT NORMAL SETUP PROCEDURES WERE FOLLOWED IN ACCORDANCE WITH THE DEVICE INSTRUCTIONS FOR USE (IFU). DESPITE THIS, THE PURGE PRESSURE ALARM PERSISTED. AS A RESULT, THE INITIAL IMPELLA RP FLEX DEVICE WAS REPLACED WITH A SECOND IMPELLA RP FLEX DEVICE. THE REPLACEMENT DEVICE WAS PREPARED AND IMPLANTED WITHOUT REPORTED ISSUES. SUPPORT WAS INITIATED AND MAINTAINED AT PERFORMANCE LEVEL P-8, ACHIEVING FLOWS OF 3.8 L/MIN. THE PATIENT REMAINED ON MECHANICAL CIRCULATORY SUPPORT. APPROXIMATELY FOUR DAYS LATER, THE PATIENT¿S FAMILY ELECTED TO WITHDRAW CARE AND THE PATIENT SUBSEQUENTLY EXPIRED. THE REPORTED DEVICE-RELATED ISSUE INVOLVED A ¿PURGE PRESSURE LOW¿ ALARM DURING PREPARATION AND PRIMING OF THE FIRST IMPELLA RP FLEX DEVICE AND THE DEVICE WAS REPLACED, AND NO FURTHER PURGE PRESSURE ALARMS OR OTHER ISSUES/COMPLICATIONS WERE REPORTED. THE PATIENT'S UNDERLYING CONDITION APPEARS TO HAVE CONTRIBUTED TO THE DEMISE OUTCOME (CARDIAC CONDITION THAT INCLUDED RECENT ORTHOTOPIC HEART TRANSPLANTATION (OHT) REJECTION, RIGHT VENTRICULAR FAILURE, AND CARDIOGENIC SHOCK STAGE E). HOWEVER, THE IMPELLA RP FLEX PUMP 1 WILL BE CONSERVATIVELY REPORTED AS DEATH. CORRECTION. AFTER REVIEW OF THE CASE BY MEDICAL SAFETY/CLINICAL, IT WAS DETERMINED THE IMPELLA IS A DEATH TYPE OF REPORTABLE EVENT. SECTIONS B1 (ADVERSE EVENT/PRODUCT PROBLEM), B2 (OUTCOMES ATTRIBUTED), H1 (TYPE OF REPORTABLE EVENT) AND H6 (HEALTH EFFECT-CLINICAL AND IMPACT CODES) HAVE BEEN UPDATED, CORRECTED ACCORDINGLY. NOTE: H6: MEDICAL DEVICE PROBLEM, COMPONENT, AND INVESTIGATION TYPE/FINDING/CONCLUSION CODING REMAINS UNCHANGED.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: RPF PUMP (B)(6) RETURNED. NO DATA LOGS WERE RETURNED FOR ANALYSIS. PURGE PRESSURE LOW: THE RETURNED PUMP WAS INVESTIGATED. THE RED LUMEN WAS STILL IN THE CANNULA, WHICH WAS REMOVED AND THE PUMP WAS PRIMED AND TRIED TO BE RUN IN THE LAB. NO OTHER VISUAL ABNORMALITIES WERE SEEN. THE LOW PURGE PRESSURE ALARMS WERE REPRODUCED IN THE LAB, WITH PURGE FLOW AT 30 ML/HR. THE BLUE HANDLE WAS OPENED TO CHECK FOR LEAKS IN THE PURGE LINE. NO LEAKS WERE OBSERVED. IT WAS SEEN IN THE LOT TRAVELER FOR THE PUMP THAT THE MANUFACTURING PURGE FLOW WAS 26.6 ML/HR, WHICH WAS CLOSE TO THE 28 ML/HR THRESHOLD FOR ACCEPTABLE PURGE FLOW RATE FOR THE PUMP. THE ROOT CAUSE OF THE PURGE PRESSURE LOW ALARMS WAS NOT DETERMINED DUE TO INCONCLUSIVE EVIDENCE FROM THE PRODUCT INVESTIGATION AND CLINICAL DETAILS. THE FAILURE WAS RELATED TO THE DEVICE BASED ON THE PRODUCT EVALUATION BUT COULD NOT BE FURTHER TRACED MORE SPECIFICALLY. PUMP #615903 PASSED ALL POST-STERILE INSPECTION CHECKS.

    Additional Manufacturer Narrative · 0

    A4 IS UNKNOWN. THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER, THEREFORE, INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT IMPLANTED WITH AN IMPELLA RP FLEX EXPERIENCED A PURGE PRESSURE LOW ALARM. THE PUMP WAS EXCHANGED FOR A NEW PUMP. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193941 IMPELLA RP FLEX TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP PYX ABIOMED, INC. IMPELLA RP FLEX 2026742024 00813502012811

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Death