BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA RP FLEX

    MDR report key: 19750990 · Received July 16, 2024

    Report

    Report Number
    1220648-2024-13129
    Event Type
    Injury
    Date Received
    July 16, 2024
    Date of Event
    July 10, 2024
    Report Date
    August 26, 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 HAS BEEN COMPLETED. THE IMPELLA RP FLEX PUMP WAS RETURNED. THE PUMP WAS VISUALLY INSPECTED AND BIOMATERIAL WAS FOUND WRAPPED BENEATH THE IMPELLER AT INFLOW. NO OTHER ABNORMALITIES WERE FOUND. THE PUMP WAS HEMOLYSIS TESTED AND PASSED WITHOUT ANY ISSUES. DATA LOGS WERE REVIEWED AND NO SUCTION ALARMS OR PLACEMENT SIGNAL TREND WAS OBSERVED. NO MOTOR CURRENT SPIKES OUTSIDE P-LEVEL CHANGES. SLIGHT UPWARD SHIFT IN PLACEMENT SIGNAL AT P-7 AND DROP IN FLOWS WITH CVP BEING NEGATIVE. ON 7/6 INCREASE IN DP~30-40 MMHG AND A SUBSEQUENT FLOW DROP OF ABOUT 0.5 LITERS PER MINUTE WITH MUTED MOTOR CURRENT SPIKE LIKELY INDICATES INGESTION TREND. THE OPTICAL SIGNAL RECOVERS AND BECOMES POSITIVE. AS PER CLINICAL DESCRIPTION, THE PATIENT WAS ON OTHER DEVICE MANAGEMENT, IMPROPER ANTICOAGULATION AND MANAGEMENT OF VOLUME WITH POOR PATIENT CONDITION. THE CAUSE OF THE HEMOLYSIS AND RENAL FAILURE ISSUES WAS PATIENT CONDITION RELATED. B.2 REVISED AS REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE (DEVICES) SHOULD OF BEEN SELECTED ON THE INITIAL MANUFACTURER DEVICE REPORT 1220648-2024-13129. D.4 REVISED MODEL NUMBER FROM THE INITIAL SUBMISSION OF MANUFACTURER DEVICE REPORT 1220648-2024-13129 IN ACCORDANCE WITH UPDATED PROCEDURES. D.9 REVISED AS THE PUMP WAS RETURNED FOR INVESTIGATION WHEN THE INITIAL MANUFACTURER DEVICE REPORT 1220648-2024-13129 WAS SUBMITTED. E.4 SHOULD HAVE BEEN LEFT BLANK IN INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-13129 AS IT IS UNKNOWN THE INITIAL REPORTER ALSO SENT THE REPORT TO THE FDA. G.1 REVISED MANUFACTURING SITE NAME AND ADDRESS SECTION AS PREVIOUSLY ENTERED INCORRECTLY ON THE INITIAL MANUFACTURER DEVICE REPORT 1220648-2024-13129. G.2 FOREIGN WAS SELECTED INCORRECTLY ON INITIAL MANUFACTURER DEVICE REPORT 1220648-2024-13129 AND SHOULD NOT HAVE BEEN. H.3 DEVICE NOT RETURNED TO MANUFACTURER FOR EVALUATION SHOULD NOT HAVE BEEN SELECTED ON THE INITIAL MANUFACTURER DEVICE REPORT 1220648-2024-13129 AS THE DEVICE WAS AVAILABLE. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN SHOULD HAVE BEEN SELECTED ON THE INITIAL MANUFACTURER DEVICE REPORT 1220648-2024-13129. H.6 CODE 4611 WAS REPORTED INCORRECTLY ON THE INITIAL MANUFACTURER DEVICE REPORT 1220648-2024-13129. A NEW CODE WAS ADDED TO HEALTH EFFECT - IMPACT CODE. H.10 ADDITIONAL MANUFACTURER NARRATIVE INSTRUCTIONS FOR USE (IFUS) WERE REPORTED ON THE PREVIOUSLY SUBMITTED MANUFACTURER DEVICE REPORT 1220648-2024-13129 INCORRECTLY. NO IFUS ARE NEEDED TO BE REPORTED FOR THIS REPORT IN ACCORDANCE WITH UPDATED PROCEDURES.

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER AND THEREFORE, AN EVALUATION OF THE DEVICE WAS NOT POSSIBLE. UPON INVESTIGATION CLOSURE, A SUPPLEMENTAL MDR WILL BE FILED. INSTRUCTIONS FOR USE FOR THE RELATED EVENT ARE AS FOLLOWS: SECTION: POTENTIAL ADVERSE EVENTS (UNITED STATES) ¿ACUTE RENAL DYSFUNCTION, AORTIC VALVE INJURY, BLEEDING, CARDIOGENIC SHOCK, CEREBRAL VASCULAR ACCIDENT/STROKE, DEATH, HEMOLYSIS, LIMB ISCHEMIA, MYOCARDIAL INFARCTION, RENAL FAILURE, THROMBOCYTOPENIA AND CARDIAC OR VASCULAR INJURY (INCLUDING VENTRICULAR PERFORATION).¿

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED A 65-YEAR-OLD MALE UNDERGOING CARDIAC SURGERY WAS IMPLANTED WITH AN IMPELLA DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. US COMPLAINANT REPORTED THE PATIENT WAS ON IMPELLA RP FLEX SUPPORT AND THE PATIENT HAD HEMOLYSIS. IT WAS REPORTED THAT THE HEMOLYSIS LED TO ORGAN DAMAGE AND DIALYSIS WAS STARTED. IMPELLA SUPPORT CONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2505032 IMPELLA RP FLEX TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP PYX ABIOMED, INC. IMPELLA RP FLEX 2025502614 00813502012811

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention| S