BEUDAMED
    FDA Adverse Event Death Summary report: N

    RP FLEX W SMART ASSIST SET, US

    MDR report key: 24607273 · Received March 16, 2026

    Report

    Report Number
    1220648-2026-05341
    Event Type
    Death
    Date Received
    March 16, 2026
    Date of Event
    December 6, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    PYX
    UDI-DI
    00813502012811
    PMA / PMN Number
    P170011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 75-YEAR-OLD MALE WITH A HISTORY OF TYPE A AORTIC DISSECTION DEVELOPED RIGHT VENTRICULAR FAILURE, PRESUMED TO BE SECONDARY TO AN OSTIAL RIGHT CORONARY ARTERY LESION. HE WAS INITIALLY SUPPORTED WITH EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). IN ANTICIPATION OF ECMO DECANNULATION, THE HEART TEAM ELECTED TO IMPLANT AN IMPELLA RP FLEX FOR RIGHT-SIDED MECHANICAL CIRCULATORY SUPPORT. FOLLOWING IMPELLA RP FLEX IMPLANTATION, THE PATIENT BECAME HEMODYNAMICALLY STABLE, AND TOLERATED WEANING OF VASOPRESSORS. THE PATIENT REMAINED ON IMPELLA RP FLEX SUPPORT WITH CLINICAL STABILITY. ON DAY 12 OF SUPPORT, THE AUTOMATED IMPELLA CONTROLLER (AIC) DISPLAYED: PLACEMENT SIGNAL NOT RELIABLE (PSNR), ELEVATED PULMONARY ARTERY PRESSURE, AND REDUCED DISPLAYED PUMP FLOW. DESPITE THESE FINDINGS THE MOTOR CURRENT REMAINED UNCHANGED, SUGGESTING PRESERVED PUMP FUNCTION AND THE PATIENT REMAINED CLINICALLY STABLE. THE CARE TEAM USED APPROVED ALTERNATIVE HEMODYNAMIC MONITORING TO GUIDE MANAGEMENT. THE PATIENT UNDERWENT TRACHEOSTOMY FOR PROLONGED MECHANICAL VENTILATION AND CONTINUED TO RECEIVE MECHANICAL CIRCULATORY SUPPORT. HE WAS SUPPORTED WITH IMPELLA RP FLEX FOR A TOTAL OF 25 DAYS. GIVEN THE PATIENT¿S CRITICAL CONDITION AND WORSENING MULTI-SYSTEM STATUS, THE FAMILY ELECTED TO WITHDRAW CARE. THE PATIENT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665074 RP FLEX W SMART ASSIST SET, US TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP PYX ABIOMED, INC. - 1220648 2025529533 00813502012811

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Death