BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA 5.5

    MDR report key: 22293655 · Received June 19, 2025

    Report

    Report Number
    1220648-2025-29586
    Event Type
    Injury
    Date Received
    June 19, 2025
    Date of Event
    May 30, 2025
    Report Date
    July 28, 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
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VT/VF IN ORDER TO MAKE A ROOT CAUSE DETERMINATION, ALL OF THE CLINICAL DETAILS OUTLINED IN ES2023-0158 WOULD HAVE TO BE PROVIDED. THE ROOT CAUSE OF THE VT/VF/AT/AF WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. THROMBUS IN ORDER TO MAKE A ROOT CAUSE DETERMINATION, ALL OF THE CLINICAL DETAILS OUTLINED IN ES2023-0158 WOULD HAVE TO BE PROVIDED. THE ROOT CAUSE OF THE THROMBUS WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. VASCULAR DAMAGE - PERIPHERAL VESSELS THE PATIENT HAD BLEEDING THROUGHOUT SUPPORT BUT THE SOURCE OF THE BLEEDING WAS UNKNOWN. DUE TO LIMITED CLINICAL INFORMATION, THE ROOT CAUSE OF THE VASCULAR DAMAGE - PERIPHERAL VESSELS CANNOT BE DETERMINED. LOW PUMP FLOW THROUGHOUT SUPPORT VOLUME WAS ADMINISTERED TO THE PATIENT, AND IT WAS STATED THAT THE PATIENT HAD VERY LITTLE PULSATILITY BUT IT WOULD IMPROVE WITH VOLUME. ON (B)(6), THE PATIENT HAD AN RV COLLAPSE AND WAS CANNULATED FOR VA-ECMO, AND IMPELLA FLOWS DECREASED. THE DATA LOGS SHOW SUCTION ALARMS THROUGHOUT SUPPORT, AND ON THE 5TH, THERE IS A LACK OF PULSATILITY SEEN IN THE MC AND TRENDING PS, AND FLOWS SIGNIFICANTLY DECREASE. THE RETURNED PRODUCT DID NOT SHOW ANY THROMBUS OR KINKS IN THE CANNULA. THE PUMP WAS UNABLE TO BE RUN AS THE CANNULA WAS DETACHED. BASED ON THE CLINICAL DETAILS PROVIDED AND DATA LOG ANALYSIS, THE ROOT CAUSE OF THE LOW PUMP FLOW IS MOST LIKELY DUE TO THE PATIENTS CONDITION. PRODUCT DAMAGE - DETACHED INFLOW/OUTFLOW THERE ARE NOT ENOUGH DETAILS SURROUNDING THE REMOVAL/EXPLANT OF THE DEVICE TO MAKE A DETERMINATION ABOUT THE ANGLE OF EXPLANT, OR WHAT OCCURRED DURING THIS TIME. THIS ISSUE HAS PREVIOUSLY BEEN SEEN ON DIRECT CASES DURING REMOVAL AND CAN BE REFERENCED IN THE PREVIOUS ESCALATION PIA-0000148. THE DESIGN TESTING HAS STATED THAT THE BOND IS TESTED TO A 30 N SPECIFICATION PER DIR550-1.1.7.2. ADDITIONALLY, THE BOND WAS RIPPED AT THE CANNULA TO PH BOND AND WAS JAGGED REMAINING ON THE CANNULA AND NOT THE MOTOR HOUSING. ON THE INSIDE OF THE CANNULA THERE WAS ALSO RESIDUAL GLUE MARKS WHERE IT WOULD BE ATTACHED TO THE MOTOR HOUSING. THERE WERE NO KINKS SEEN IN THE CANNULA OR THE CATHETER. DUE TO A LACK OF SUFFICIENT EVIDENCE DURING THE REMOVAL OF THE 5.5 AND EVIDENCE OF THE GLUE BOND, THE ROOT CAUSE OF THE PRODUCT DAMAGE (DETACHED INFLOW/OUTFLOW) CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS RETURNED, AND AN EVALUATION IS UNDERWAY. UPON COMPLETION OF OUR ANALYSIS, A SUPPLEMENTAL REPORT WILL BE FILED. THE INSTRUCTIONS FOR USE FOR THE IMPELLA 5.5 WITH SMART ASSIST FOR USE DURING CARDIOGENIC SHOCK STATES THE FOLLOWING: 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 THE PATIENT WAS ON IMPELLA 5.5 SUPPORT AND DURING SUPPORT, THE PATIENT HAD FREQUENT ECTOPY AND TACHYCARDIA. SUPPORT CONTINUED. ADDITIONALLY, THERE WERE SUCTION ALARMS. TWO (2) UNITS OF BLOOD PRODUCTS WERE GIVEN TO THE PATIENT. ALSO, THE PATIENT HAD A PERICARDIAL HEMATOMA. THE PATIENT WAS INTUBATED AND CANNULATED FOR PERIPHERAL VA-ECMO. AT THE TIME OF CANNULATION, IMPELLA FLOWS ACUTELY DROPPED FOLLOWING A SUCTION ALARM WITH DAMPENING MOTOR CURRENT, JUMP IN AO PLACEMENT SIGNAL (THAT NO LONGER CORRELATED WITH ARTERIAL PRESSURE) AND EXTREMELY LOW IMPELLA FLOWS. PATIENT TAKEN TO THE OPERATING ROOM FOR CHEST WASHOUT. CHEST RE-OPENED, COPIOUS AMOUNT OF OLD CLOT REMOVED FROM THE PERICARDIUM. NO LEFT VENTRICLE THROMBUS WAS NOTED. IMPELLA REMOVED VIA GRAFT WITH USUAL AMOUNT OF TENSION, BUT SEPARATED AT THE JUNCTION BETWEEN THE OUTLET CAGE AND CANNULA. GRAFT CLAMPED AT LEVEL OF AORTA, DISTAL PORTION OF THE CANNULA LOCATED WITHIN THE GRAFT AND REMOVED. CANNULA AND OUTLET/IMPELLER INSPECTED, NO CLOT VISUALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852879 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.5 2026666895 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Required Intervention