BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RP FLEX W SMART ASSIST SET, US

    MDR report key: 24354689 · Received February 16, 2026

    Report

    Report Number
    1220648-2026-03317
    Event Type
    Injury
    Date Received
    February 16, 2026
    Date of Event
    October 21, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    PYX
    UDI-DI
    00813502012811
    PMA / PMN Number
    P170011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION HAS BEEN PROVIDED IN D1, D4 (CATALOG, LOT #, EXPIRATION DATE AND UDI) AND H4 (DEVICE MANUFACTURE DATE). 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

    CORRECTED: D4 (SERIAL). RESPIRATORY FAILURE/CARDIOGENIC SHOCK: THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. MAJOR BLEED/ ACCESS SITE ADVERSE EVENT: THE CAUSE OF THE BLEED WAS MOST LIKELY USE ISSUE RELATED SINCE THE INITIAL MATTRESS SUTURE WAS NOT PLACED AND SITE REQUIRED ADDITIONAL PURSE-STRING SUTURE ALONG WITH PATIENT MOVEMENT.

    Description of Event or Problem · 0

    73-YEAR-OLD MALE WITH A HISTORY OF PROSTATE CANCER TREATED WITH RADIATION THERAPY. THE PATIENT PRESENTED TO AN OUTSIDE HOSPITAL WITH DIZZINESS AND NAUSEA AND WAS FOUND TO BE IN ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE AND ACUTE KIDNEY INJURY. HE WAS TRANSFERRED TO A HIGHER-LEVEL FACILITY AFTER AN ELEVATED TROPONIN WAS IDENTIFIED. A URINALYSIS REVEALED A URINARY TRACT INFECTION, WHICH WAS TREATED WITH ANTIBIOTICS. THE FOLLOWING DAY, CHEST CT ANGIOGRAPHY CONFIRMED BILATERAL PULMONARY EMBOLI WITH RIGHT VENTRICULAR STRAIN. HE UNDERWENT SUCCESSFUL THROMBECTOMY BUT CONTINUED TO DECOMPENSATE, REQUIRING INCREASING PRESSORS, INOTROPES, PULMONARY VASODILATORS, AND OXYGEN THERAPY. A HEART TEAM DETERMINED THE NEED FOR IMPELLA RP FLEX FOR RIGHT-SIDED CIRCULATORY SUPPORT. USE OF IMPELLA RP FLEX IN PULMONARY EMBOLISM IS OFF-LABEL DUE TO THE RISK OF CLOT INGESTION. RIGHT HEART CATHETERIZATION CONFIRMED SEVERE RIGHT VENTRICULAR DYSFUNCTION WITH THE FOLLOWING HEMODYNAMICS: RIGHT ATRIUM (RA): 18 MMHG. RIGHT VENTRICLE (RV): 49/17 MMHG. PULMONARY ARTERY (PA): 56/38 (MEAN 42) MMHG. PULMONARY CAPILLARY WEDGE PRESSURE (PCWP): 16 MMHG. PULMONARY ARTERY SATURATION: 45%. CARDIAC INDEX: 1.2 L/MIN/M². PULMONARY ARTERY PULSATILITY INDEX: 0.9. DURING IMPLANTATION, THE PATIENT REQUIRED DOBUTAMINE, VASOPRESSIN, LEVOPHED, AND INTERMITTENT EPINEPHRINE BOLUSES. HEMOSTASIS WAS ACHIEVED WITH A HEMOSTATIC SUTURE, MANUAL PRESSURE, AND A FEM-STOP DEVICE APPLIED TO THE ACCESS SITE. HEMODYNAMICS IMPROVED WITH IMPELLA RP FLEX AT P-8, AND TRANSTHORACIC ECHOCARDIOGRAPHY DEMONSTRATED IMPROVED RIGHT VENTRICULAR FUNCTION. THE FOLLOWING DAY, THE FEM-STOP WAS REMOVED, AND THE PATIENT WAS PLACED ON SYSTEMIC HEPARIN AND HEPARIN PURGE, LATER TRANSITIONED TO ARGATROBAN SYSTEMICALLY AND SODIUM BICARBONATE IN THE PURGE. A VENOUS DUPLEX REVEALED RESIDUAL THROMBUS IN THE RIGHT FEMORAL VEIN. DESPITE IMPROVED RV PERFORMANCE, THE PATIENT DEVELOPED INCREASING OXYGEN REQUIREMENTS AND DID NOT TOLERATE IMPELLA RP FLEX WEANING. HE WAS TRANSFERRED TO A HIGHER LEVEL OF CARE AND ESCALATED TO VA-ECMO AND PROTEK DUO FOR RESPIRATORY FAILURE AND RIGHT-SIDED SUPPORT. DETAILED EVENT CHRONOLOGY INITIAL PRESENTATION. PRESENTED WITH DIZZINESS AND NAUSEA. FOUND IN ATRIAL FIBRILLATION WITH RVR; DEVELOPED ACUTE KIDNEY INJURY. ELEVATED TROPONIN PROMPTED TRANSFER TO TERTIARY CENTER. UTI IDENTIFIED AND TREATED WITH ANTIBIOTICS. DIAGNOSIS OF PULMONARY EMBOLISM. CHEST CTA CONFIRMED BILATERAL PULMONARY EMBOLI WITH RV STRAIN. THROMBECTOMY AND CLINICAL DECOMPENSATION. UNDERWENT SUCCESSFUL PULMONARY EMBOLISM THROMBECTOMY. CONTINUED TO DECOMPENSATE WITH RISING VASOPRESSOR AND INOTROPE REQUIREMENTS. PULMONARY VASODILATORS AND OXYGEN THERAPY INITIATED. IMPELLA RP FLEX IMPLANTATION (OFF-LABEL) HEART TEAM ELECTED TO IMPLANT IMPELLA RP FLEX FOR SEVERE RV FAILURE. RIGHT HEART CATHETERIZATION SHOWED SEVERE HEMODYNAMIC COMPROMISE. PATIENT SUPPORTED WITH DOBUTAMINE, VASOPRESSIN, LEVOPHED, AND INTERMITTENT EPINEPHRINE DURING PROCEDURE. ACCESS SITE SECURED WITH HEMOSTATIC SUTURE, MANUAL PRESSURE, AND FEM-STOP. POST-IMPLANT COURSE. IMPROVED HEMODYNAMICS ON IMPELLA RP FLEX AT P-8. IMPROVED RV FUNCTION DEMONSTRATED ON TRANSTHORACIC ECHO. DAY 1 POST-IMPLANT. FEM-STOP REMOVED. ANTICOAGULATION TRANSITIONED FROM SYSTEMIC HEPARIN + HEPARIN PURGE TO ARGATROBAN + SODIUM BICARBONATE PURGE. DUPLEX SHOWED RESIDUAL RIGHT FEMORAL VEIN THROMBUS. CLINICAL DECLINE AND ESCALATION PATIENT DEVELOPED INCREASING OXYGEN REQUIREMENTS. UNABLE TO TOLERATE IMPELLA RP FLEX WEANING. TRANSFERRED TO HIGHER ACUITY CENTER. ESCALATED TO VA-ECMO + PROTEK DUO FOR RESPIRATORY FAILURE AND RIGHT-SIDED CIRCULATORY SUPPORT. OUTCOME PATIENT COULD NOT BE WEANED FROM IMPELLA RP FLEX. ESCALATED TO VA-ECMO AND PROTEK DUO. IMPELLA RP FLEX SUPPORT WAS DISCONTINUED AS PART OF TRANSITION TO ALTERNATIVE MECHANICAL SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147741 RP FLEX W SMART ASSIST SET, US TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP PYX ABIOMED, INC. 2026705413 00813502012811

    Patients

    Seq Age Sex Outcome Treatment
    1