BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA RP FLEX

    MDR report key: 19764134 · Received July 17, 2024

    Report

    Report Number
    1220648-2024-13156
    Event Type
    Injury
    Date Received
    July 17, 2024
    Date of Event
    July 10, 2024
    Report Date
    August 30, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    PYX
    UDI-DI
    00813502012811
    PMA / PMN Number
    P170011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION FOR THE HEMOLYSIS HAS BEEN COMPLETED. IMPELLA RP FLEX PUMP WAS RETURNED. VISUAL INSPECTION WAS PERFORMED FINDING BIOMATERIAL WAS FOUND WRAPPED BENEATH IMPELLER AT INFLOW. NO OTHER ABNORMALITIES WERE FOUND. RP FLEX PUMP WAS TESTED FOR HEMOLYSIS AND PASSED WITH MIH VALUE WITHIN LIMITS. DATA LOGS WERE REVIEWED, SUCTION ALARMS AND NOISY PLACEMENT SIGNAL FOUND. ALSO MOTOR CURRENT VARIATION DURING SUCTION WITH NO P-LEVEL CHANGES WAS SEEN. SLIGHT MOTOR CURRENT (MC) SPIKE AND UPWARD SHIFT IN PLACEMENT SIGNAL OCCURRED AS WELL. DROP IN FLOWS WAS OBSERVED AT P-7 FROM 2.8 TO 2.4 L/MIN ON 07/08. RP FLEX PUMP WAS ON LOW FLOWS DURING MOST OF THE CASE. ABNORMAL WAVEFORMS OBSERVED DURING WASHOUT OF HEMOTHORAX. AS PER CLINICAL PATIENT WAS ON OTHER DEVICE MANAGEMENT, IMPROPER ANTICOAGULATION AND MANAGEMENT OF VOLUME WITH POOR PATIENT CONDITION. THE CAUSE OF THE HEMOLYSIS ISSUE WAS PATIENT CONDITION RELATED. THE CAUSE OF THE RENAL FAILURE ISSUE WAS PATIENT CONDITION RELATED. THE INSTRUCTIONS FOR USE FOR THE IMPELLA RP SMARTASSIST SYSTEM WITH AUTOMATED IMPELLA CONTROLLER STATES THE FOLLOWING: SECTION: POTENTIAL ADVERSE EVENTS (UNITED STATES). ¿ARRHYTHMIA, ATRIAL FIBRILLATION, BLEEDING, CARDIAC TAMPONADE, CARDIOGENIC SHOCK, DEATH, DEVICE MALFUNCTION, HEMOLYSIS, HEPATIC FAILURE, INSERTION SITE INFECTION, CARDIAC OR VASCULAR INJURY (INCLUDING VENTRICULAR PERFORATION)¿. ADDED B5 ADDITIONAL NARRATIVE., H6 CLINICAL CODE 2041, H6 IMPACT CODE 4641.

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE HAS BEEN RETURNED, AND AN EVALUATION IS UNDERWAY. UPON COMPLETION OF OUR ANALYSIS, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS FURTHER REPORTED THAT THE PATIENT WAS PLACED ON CONTINOUS RENAL REPLACEMENT THERAPY WHILE ON RP SUPPORT.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED A 64-YEAR-OLD FEMALE PATIENT WITH POST-OPERATION LEFT VENTRICULAR ASSIST DEVICE WAS IMPLANTED WITH AN IMPELLA RP FLEX FOR MECHANICAL CIRCULATORY SUPPORT. THE IMPELLA RP FLEX WAS PLACED IN CONJUNCTION WITH A PRIOR IMPELLA CP IMPLANT AND A HEARTMATE 3. THE COMPLAINANT REPORTED THE IMPELLA RP FLEX WAS EXPLANTED DUE TO CONCERNS OF HEMOLYSIS FROM CONFIRMED ELEVATED PLASMA-FREE HEMOGLOBIN LEVELS. THE PATIENT SURVIVED THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2148718 IMPELLA RP FLEX TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP PYX ABIOMED, INC. IMPELLA RP FLEX 2025502613 00813502012811

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention