BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA 5.5

    MDR report key: 23818674 · Received December 16, 2025

    Report

    Report Number
    1220648-2025-49073
    Event Type
    Injury
    Date Received
    December 16, 2025
    Date of Event
    November 17, 2025
    Report Date
    January 12, 2026
    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
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO PRODUCT OR LOGS WERE RETURNED FOR EVALUATION. THROMBOSIS: CLINICAL DETAILS NOTED THAT A CLOT WAS PRESENT AROUND THE MOTOR HOUSING ON EXPLANT. IN ORDER TO MAKE A CAUSE DETERMINATION, ALL OF THE CLINICAL DETAILS OUTLINED IN ES2023-0158 WOULD HAVE TO BE PROVIDED. THE ROOT CAUSE OF THE INJURY WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. DEVICE IN WRONG POSITION: CLINICAL DETAILS NOTED THAT AFTER PUMP WAS INSERTED IN LV, PHYSICIAN WAS UNABLE TO VISUALIZE THE TIP OF THE IMPELLA AND PULLED BACK THE PUMP POSITION. THE PUMP WAS PULLED BACK INTO THE AORTA AND HAD TO BE REMOVED. THE PUMP WAS RINSED WITH STERILE SALINE, THEN REINSERTED WITH A NEW AXILLARY INSERTION KIT. THE CAUSE OF THE POSITIONING ISSUE WAS DETERMINED TO BE AN UNINTENTIONAL USE ERROR AS THE PUMP WAS PULLED INTO THE AORTA WHEN PHYSICIAN WAS PULLING BACK PUMP. PURGE SYSTEM BLOCKED: CLINICAL DETAILS NOTED THAT A "PURGE SYSTEM BLOCKED" ALARM OCCURRED OVERNIGHT. TPA WAS ADDED TO PURGE AND WAS ABLE TO RESOLVE ISSUE. THE CAUSE OF THE PURGE SYSTEM BLOCKED COULD NOT BE DETERMINED AS NO PRODUCT OR LOGS WERE RETURNED FOR EVALUATION. DEVICE HISTORY LOT: DEVICE LOT: 1980876. DEVICE HISTORY BATCH: SUBCOMPONENT LOT; N/A. DEVICE HISTORY REVIEW: PUMP SN (B)(6) PASSED ALL POST-STERILE INSPECTION CHECKS.

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS DISCARDED BY THE CUSTOMER AND THEREFORE, AN EVALUATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED. AS NOTED IN THE IMPELLA INSTRUCTIONS FOR USE: IMPELLA 5.5 WITH SMART ASSIST FOR USE DURING CARDIOGENIC SHOCK. 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: WARNINGS & CAUTIONS: WARNINGS: SECTION: PRE-SUPPORT EVALUATION. SECTION: AXILLARY INSERTION OF THE IMPELLA 5.5 CATHETER. SECTION: DIRECT AORTIC INSERTION. SECTION: USE OF IMPELLA WITH TRANSCATHETER AORTIC VALVES. "IN PATIENTS WITH TRANSCATHETER AORTIC VALVES POSITION THE IMPELLA SYSTEM CAREFULLY TO AVOID INTERACTION WITH THE TRANSCATHETER AORTIC VALVE PROSTHESIS. UNINTENTIONAL INTERACTION OF THE IMPELLA MOTOR HOUSING WITH THE TAVR DEVICE MAY RESULT IN DESTRUCTION OF THE IMPELLER BLADES. THIS CAN LEAD TO SYSTEMIC EMBOLIZATION, SERIOUS INJURY, OR DEATH." IN THIS SITUATION, AVOID REPOSITIONING WHILE THE DEVICE IS RUNNING; TURN THE DEVICE TO P0 DURING REPOSITIONING OR ANY MOVEMENT THAT COULD BRING THE OUTLET WINDOWS INTO PROXIMITY TO THE VALVE STENT STRUCTURES. IF THERE IS LOW FLOW OBSERVED IN A PATIENT IMPLANTED WITH A TRANSCATHETER AORTIC VALVE PROSTHESIS, CONSIDER DAMAGE OF THE IMPELLER AND REPLACE THE IMPELLA AS SOON AS POSSIBLE.¿

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WAS TRANSFERRED TO A DIFFERENT HOSPITAL FOR FURTHER CARE. THE PATIENT WAS PRESENT FOR A PLANNED IMPELLA 5.5 WITH A POTENTIAL EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) RECONFIGURATION/GROIN REPAIR OF ECMO SITE. THE MEDICAL DOCTOR (MD) GAINED LEFT VENTRICLE ACCESS WITH THE IMPELLA, REMOVED THE WIRE, AND STARTED THE IMPELLA AT P2. THE MD REMOVED THE PEEL AWAY AND SUTURED THE IMPELLA AT THE BLUE SUTURE HUB IN PLACE. THE DOCTOR THEN TRIED TO MANIPULATE THE POSITIONING AND THE IMPELLA FELL BACK INTO THE AORTA. THIS REQUIRED ANOTHER AXILLARY INSERTION KIT AND 0.018 WIRE WAS TO BE USED. NINE DAYS LATER, IT WAS REPORTED THAT THE IMPELLA PURGE BECAME BLOCKED OVERNIGHT. PURGE FLOW WAS LESS THAN 1.0 MILLILITER. THE MD TEAM SWITCHED TO TISSUE PLASMINOGEN ACTIVATOR (TPA) FOR PURGE ON THEIR OWN. PURGE FLOW REMAINS LESS THAN 1.0 NOW. THE DEVICE WAS REMOVED DUE TO A SUSPECTED CLOT AND PURGE FLOW BLOCKED. THE PURGE FLOW HAD NORMALIZED AFTER TPA WAS USED BY THE STAFF ON THEIR OWN ACCORD. HOWEVER, THEY STILL DECIDED TO REMOVE THE PUMP. THE PUMP HAD A LARGE CLOT ON MOTOR HOUSING IN A CIRCUMFERENTIAL MANNER ABOVE THE OUTLET PORTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2205968 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.5 2026747046 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention EXTRACORPOREAL MEMBRANE OXYGENATION.