BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA 5.5

    MDR report key: 22194565 · Received June 12, 2025

    Report

    Report Number
    1220648-2025-29253
    Event Type
    Malfunction
    Date Received
    June 12, 2025
    Date of Event
    May 20, 2025
    Report Date
    July 3, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE WAS RETURNED ON 28-MAY-2025 AND AN EVALUATION/INVESTIGATION IS UNDERWAY. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL MDR WILL BE FILED.

    Additional Manufacturer Narrative · 0

    PRODUCT WAS RETURNED. 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. THE PRODUCT HAD A CLAMP MARK BUT IT WAS STATED THAT THAT WAS FROM RETRIEVING THE CANNULA. ADDITIONALLY, THE BOND CAN BE SEEN ATTACHED TO THE MOTOR HOUSING WITH NO RIPS OR ANY OTHER INDICATIONS OF DAMAGE. ON THE INSIDE OF THE CANNULA THERE WAS ALSO RESIDUAL GLUE MARKS SEEN, INDICATING THERE WAS ADHESION OF THE CANNULA TO THE MOTOR HOUSING. THERE WAS A SLIGHT BEND IN THE CATHETER NEAR THE MOTOR HOUSING BUT NO KINKS. THERE WAS NO CLOT FOUND. DUE TO A LACK OF SUFFICIENT EVIDENCE DURING THE REMOVAL OF THE 5.5, THE ROOT CAUSE OF THE PRODUCT DAMAGE (DETACHED INFLOW/OUTFLOW) CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    US COMPLAINANT REPORTED THE PATIENT WAS ON IMPELLA 5.5 SUPPORT AND UPON EXPLANT, THE GRAFT WAS EXPOSED AND THE IMPELLA WAS REMOVED THROUGH THE GRAFT. WHEN THE IMPELLA WAS REMOVED, THE CANNULA WAS DETACHED FROM THE OUTFLOW ON MOTOR HOUSING CATHETER. THE CANNULA WAS AT THE PROXIMAL END OF THE GRAFT AND WAS REMOVED. GRAFT WAS STAPPLED AND INCISION WAS CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2032968 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.5 2026655586 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male