BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA CP

    MDR report key: 19702560 · Received July 9, 2024

    Report

    Report Number
    1220648-2024-13018
    Event Type
    Injury
    Date Received
    July 9, 2024
    Date of Event
    May 29, 2024
    Report Date
    August 9, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502011876
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF HEMOLYSIS HAS BEEN COMPLETED. THE IMPELLA DEVICE WAS NOT RETURNED FOR EVALUATION. WITHOUT ADDITIONAL CLINICAL DETAILS, THE ROOT CAUSE OF THE REPORTED ISSUES COULD NOT BE DETERMINED. THE FOLLOWING HAVE BEEN REPORTED INCORRECTLY OR MISSING FROM MANUFACTURER DEVICE REPORT 1220648-2024-13018: G1 MANUFACTURING SITE ADDRESS LINE 1. G1 MANUFACTURING SITE ADDRESS LINE 2 SHOULD HAVE BEEN LEFT BLANK. H.6 CODE 4755 WAS REPORTED INCORRECTLY. NEW CODE WAS ADDED TO COMPONENT CODE.

    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).¿ SECTION: USE OF ECHOCARDIOGRAPHY FOR POSITIONING OF THE IMPELLA CATHETER ¿EVALUATE THE POSITION OF THE IMPELLA CATHETER IF THE AUTOMATED IMPELLA CONTROLLER DISPLAYS POSITION ALARMS OR IF YOU OBSERVE LOWER THAN EXPECTED FLOWS OR SIGNS OF HEMOLYSIS. IF THE CATHETER DOES NOT APPEAR TO BE CORRECTLY POSITIONED, INITIATE STEPS TO REPOSITION IT.¿ IMPELLA CATHETER TOO FAR INTO THE LEFT VENTRICLE ¿OBSTRUCTION OF THE IMPELLA CATHETER INLET AREA CAN LEAD TO INCREASED MECHANICAL FORCES ON BLOOD CELL WALLS AND SUBSEQUENT HEMOLYSIS, WHICH OFTEN PRESENTS AS DARK OR BLOOD COLORED URINE.¿ SECTION: HEMOLYSIS ¿HEMOLYSIS SHOULD BE MONITORED DURING SUPPORT. PATIENTS WHO DEVELOP HIGH LEVELS OF HEMOLYSIS MAY SHOW SIGNS OF DECREASED HEMOGLOBIN LEVELS, DARK OR BLOOD-COLORED URINE, AND IN SOME CASES, ACUTE RENAL FAILURE. PLASMA-FREE HEMOGLOBIN (PFHGB) IS THE BEST INDICATOR TO CONFIRM WHETHER A PATIENT IS EXPOSED TO AN UNACCEPTABLE LEVEL OF HEMOLYSIS¿ ¿PATIENT CONDITIONS¿ INCLUDING CATHETER POSITION, PRE-EXISTING MEDICAL CONDITIONS, AND SMALL LEFT VENTRICULAR VOLUMES¿ MAY ALSO PLAY A ROLE IN PATIENT SUSCEPTIBILITY TO HEMOLYSIS.¿ SECTION: SUCTION ¿SUCTION MAY OCCUR IF THE BLOOD VOLUME AVAILABLE FOR THE IMPELLA CATHETER IS INADEQUATE OR RESTRICTED. SUCTION LIMITS THE AMOUNT OF SUPPORT THAT THE IMPELLA CATHETER CAN PROVIDE TO THE PATIENT AND RESULTS IN A DECREASE IN ARTERIAL PRESSURE AND CARDIAC OUTPUT. IT CAN DAMAGE BLOOD CELLS, LEADING TO HEMOLYSIS. IT MAY ALSO BE AN INDICATOR OF RIGHT HEART FAILURE.¿

    Description of Event or Problem · 0

    WE RECEIVED A NOTIFICATION VIA ABIOMED¿S LONG-TERM OUTCOME AND QUALITY INDICATOR IMPELLA REGISTRY REGARDING A PATIENT THAT ENDURED HEMOLYSIS WITH A "DEFINITE" RELATIONSHIP TO THE IMPELLA DEVICE USED: ¿THE PATIENT DEVELOPED HEMOLYSIS. TOTAL BILIRUBIN ON ADMISSION 0.9 MG/DL, PEAK ((B)(6) 2024) 2.2 MG/DL; LDH PEAK ((B)(6) 2024) 583 U/L; TOTAL HEMOGLOBIN ON ADMISSION 14.3 G/DL, NADIR 7.1 G/DL ((B)(6) 2024), NADIR ON IMPELLA SUPPORT 7.3 G/DL ((B)(6) 2024).¿ THE PATIENT RECOVERED WITH NO SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210682 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2025485664 00813502011876

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention