BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RP FLEX W SMART ASSIST SET, US

    MDR report key: 24559736 · Received March 10, 2026

    Report

    Report Number
    1220648-2026-04905
    Event Type
    Injury
    Date Received
    March 10, 2026
    Date of Event
    December 21, 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
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B5: ADDED NEW INFORMATION . D1: CORRECTED BRAND NAME. D4: CORRECTED SERIAL NUMBER.

    Additional Manufacturer Narrative · 0

    HEMODYNAMIC INSTABILITY: THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. HEMOLYSIS/MECHANICAL INTERACTION WITH BLOOD: THE ROOT CAUSE OF THE HEMOLYSIS WAS NOT DETERMINED DUE TO LACK OF SUFFICIENT CLINICAL DETAILS AND UNRETURNED PRODUCT FOR FURTHER INVESTIGATION. LOW OR BLOCKED PUMP FLOW: THE ROOT CAUSE OF THE LOW OR BLOCKED PUMP FLOW WAS NOT DETERMINED DUE TO LACK OF SUFFICIENT CLINICAL DETAILS AND UNRETURNED PRODUCT AND DATA LOGS FOR FURTHER INVESTIGATION.

    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

    THE NURSE REPORTED THAT THE PATIENT WAS HEMOLYZING LAST NIGHT AS URINE WAS DARK RED/TEA COLORED. URINE IS NOW CLEARED UP

    Description of Event or Problem · 0

    A 36-YEAR-OLD FEMALE WITH A HISTORY OF CARDIAC SURGERY DEVELOPED POST-CARDIOTOMY CARDIOGENIC SHOCK, INITIALLY TREATED WITH INOTROPES AND VASOPRESSORS. DUE TO PERSISTENT HEMODYNAMIC INSTABILITY, A MULTIDISCIPLINARY HEART TEAM ELECTED TO IMPLANT AN IMPELLA RP FLEX FOR RIGHT-SIDED MECHANICAL CIRCULATORY SUPPORT. FOLLOWING DEVICE IMPLANTATION, THE PATIENT¿S HEMODYNAMICS IMPROVED, ALLOWING WEANING OF VASOACTIVE THERAPY. ON DAY 3 OF IMPELLA RP FLEX SUPPORT, THE PATIENT DEVELOPED DARK-COLORED URINE, RAISING CONCERN FOR HEMOLYSIS. THIS FINDING SUBSEQUENTLY RESOLVED WITHOUT ADDITIONAL INTERVENTION. THE NEXT MORNING, TRANSTHORACIC ECHOCARDIOGRAPHY REVEALED THAT THE PUMP OUTLET HAD MIGRATED BELOW THE PULMONIC VALVE. THE CARDIOLOGIST ADVANCED THE DEVICE TO REPOSITION THE OUTLET BACK ACROSS THE PULMONIC VALVE INTO THE PULMONARY ARTERY. LATER THE SAME DAY, THE IMPELLA RP FLEX DEMONSTRATED A SIGNIFICANT REDUCTION IN FLOW TO 0.5 L/MIN. NO REPORT OF SUDDEN MOTOR CURRENT ABNORMALITY PRIOR TO TROUBLESHOOTING. GIVEN THE MARKED REDUCTION IN DEVICE OUTPUT, THE CARDIOLOGIST ELECTED TO REMOVE AND REPLACE THE IMPELLA RP FLEX. IN THE CARDIAC CATHETERIZATION LABORATORY THE IMPELLA RP FLEX WAS REMOVED, VISIBLE BIOMATERIAL / CLOT WAS NOTED IN THE INLET CAGE UPON EXPLANTATION. A NEW IMPELLA RP FLEX WAS SUCCESSFULLY IMPLANTED. THE PATIENT EXPERIENCED NO HEMODYNAMIC INSTABILITY DURING THE EXCHANGE. THE PATIENT REMAINED THERAPEUTIC ON SYSTEMIC HEPARIN THROUGHOUT THE DEVICE EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623276 RP FLEX W SMART ASSIST SET, US TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP PYX ABIOMED, INC. - 1220648 2026686556 00813502012811

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female Required Intervention