BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA 5.5

    MDR report key: 21652054 · Received March 20, 2025

    Report

    Report Number
    1220648-2025-26844
    Event Type
    Death
    Date Received
    March 20, 2025
    Date of Event
    February 22, 2025
    Report Date
    October 1, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER, THEREFORE, INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED. AS NOTED IN THE IMPELLA INSTRUCTIONS FOR USE: IMPELLA 5.5 WITH SMARTASSIST FOR USE DURING CARDIOGENIC SHOCK ¿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.¿

    Additional Manufacturer Narrative · 0

    H1 TYPE OF REPORT ERRONEOUSLY SELECTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-26844.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF OPTICAL SIGNAL ISSUES, PER FDA RECOMMENDATION. THE INVESTIGATION HAS BEEN COMPLETED FOR OPTICAL SIGNAL ISSUE AND HEMOLYSIS. NO PRODUCT WAS RETURNED FOR ANALYSIS. THE DATA LOGS WERE EVALUATED AND THE 5S PARAMETERS WERE ANALYZED AND IT WAS SUSPECTED THAT THERE WAS POSSIBLY THE PRESENCE OF AN ADDITIONAL DEVICE CAUSING AN EFFECT OF THE PLACEMENT SIGNAL. THE ROOT CAUSE OF THE OPTICAL SIGNAL ISSUE WAS NOT DETERMINED AS NO PRODUCT WAS RETURNED AND LIMITED CLINICAL INFORMATION RELATED TO FAILURE WAS PROVIDED. THE DATA LOGS SHOWED NO MOTOR CURRENT SPIKES. CLINICAL MENTION THAT GOOD PUMP POSITION WAS CONFIRMED. IT IS UNKNOWN IF HEMOLYSIS RESOLVED WITH PUMP REPOSITIONING OR REMOVAL. THE ROOT CAUSE OF THE HEMOLYSIS WAS NOT DETERMINED AS NO PRODUCT WAS RETURNED AND INSUFFICIENT CLINICAL INFORMATION RELATED TO FAILURE WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE SUSPECT DEVICE, APPLICABLE QUALITY NOTIFICATIONS, AND HISTORICAL COMPLAINT DATA WAS CONDUCTED. THIS REVIEW REVEALED THAT THE PRODUCT MET ALL MANUFACTURING RELEASE CRITERIA, AND NO PRODUCT DEFICIENCIES WERE IDENTIFIED AT THE TIME PRODUCT WAS MANUFACTURED AND RELEASED TO THE CUSTOMER. ALL PERTINENT INFORMATION AVAILABLE TO ABIOMED HAS BEEN SUBMITTED AT THIS TIME. B1 PRODUCT PROBLEM UPDATED. B5 UPDATED TO INCLUDE OPTICAL SIGNAL ISSUE DESCRIPTION. H6 UPDATED TO INCLUDE OPTICAL SIGNAL CODING.

    Description of Event or Problem · 0

    THE COMPLAINANT HAD A IMPELLA 5.5 PUMP PLACED AS CARE ESCALATION FROM THE IMPELLA CP. IT WAS REPORTED THAT THE PATIENTS HAD ON AND OFF CONCENTRATED AMBER/RED URINE OUTPUT. IT WAS FURTHER REPORTED THAT CARE WAS WITHDRAWN AND THE PATIENT EXPIRED. THERE IS NOT ENOUGH EVIDENCE TO EXCLUDE IMPELLA AS AN ASSOCIATED FACTOR IN THE PATIENT'S OUTCOME.

    Description of Event or Problem · 0

    THE COMPLAINANT ALSO REPORTED THAT THE IMPLANTED IMPELLA 5.5 PUMP EXPERIENCED INTERMITTENT PLACEMENT SIGNAL ISSUES DURING PATIENT SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1373007 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.5 2025508818 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Death