BEUDAMED
    FDA Adverse Event Death Summary report: N

    RP FLEX W SMART ASSIST SET, US

    MDR report key: 24547774 · Received March 9, 2026

    Report

    Report Number
    1220648-2026-04792
    Event Type
    Death
    Date Received
    March 9, 2026
    Date of Event
    November 11, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    PYX
    UDI-DI
    00813502012811
    PMA / PMN Number
    P170011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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

    D1. BRAND NAME CORRECTED. D4. SERIAL AND PRIMARY UDI NUMBER CORRECTED. H6: INVESTIGATION: TYPE, FINDINGS, CONCLUSION CODES AND H6 COMPONENT CODES WERE UPDATED ACCORDINGLY BASED ON THE COMPLETED INVESTIGATION. THE DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION/ANALYSIS OF THE DEVICE WAS NOT POSSIBLE. ANEMIA: THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. HEMOLYSIS/MECHANICAL INTERACTION WITH BLOOD: NO LOGS WERE RETURNED. THE CAUSE OF THE HEMOLYSIS CANNOT BE DETERMINED SINCE NO PRODUCT OR DATA LOGS WERE RETURNED AND INSUFFICIENT CLINICAL DETAILS WERE PROVIDED.

    Description of Event or Problem · 0

    AN 81-YEAR-OLD FEMALE WITH A HISTORY OF RECENT MYOCARDIAL INFARCTION, POSSIBLE STROKE, ATRIAL FIBRILLATION AND CORONARY BYPASS GRAFTING WAS ADMITTED FOR A PERCUTANEOUS CORONARY INTERVENTION WITH SUPPORT OF AN IMPELLA CP. PLACEMENT OF THE PUMP AND THE PROCEDURE WERE CARRIED OUT AND THE PATIENT ADMITTED TO THE INTENSIVE CARE UNIT ON SUPPORT. DUE TO INCREASING RIGHT VENTRICULAR FAILURE, AN IMPELLA RP FLEX WAS ADDED AFTER TWO DAYS OF SUPPORT. WITHOUT OBVIOUS SIGNS OF BLEEDING, THE PATIENT BECAME ANEMIC AND REQUIRED BLOOD TRANSFUSIONS. SHORTLY AFTER, URINE COLOR WAS SUGGESTIVE OF HEMOLYSIS THAT RESOLVED AFTER DIFFERENTIATED PUMP SPEED AND VOLUME MANAGEMENT. AFTER 4 DAYS OF SUPPORT, DUE TO THE POOR PROGNOSIS OF THE UNDERLYING DISEASE, CARE WAS WITHDRAWN AND THE PATIENT EXPIRED. THE DEATH IS MOST LIKELY ATTRIBUTABLE TO THE PATIENTS UNDERLYING CRITICAL CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35068 RP FLEX W SMART ASSIST SET, US TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP PYX ABIOMED, INC. - 1220648 2026639410 00813502012811

    Patients

    Seq Age Sex Outcome Treatment
    1