BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA 5.5

    MDR report key: 23106175 · Received September 21, 2025

    Report

    Report Number
    1220648-2025-46715
    Event Type
    Injury
    Date Received
    September 21, 2025
    Date of Event
    June 11, 2025
    Report Date
    September 21, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    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 IMPELLA DEVICE HAS NOT BEEN RECEIVED FROM THE CUSTOMER. THEREFORE, INVESTIGATION OF THE DEVICE IS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Additional Manufacturer Narrative · 0

    CORRECTION: E4. THE INVESTIGATION OF THE REPORTED FAILURE MODE HAS BEEN COMPLETED. NO PRODUCT WAS RETURNED FOR INVESTIGATION. THROMBOCYTOPENIA: THE CAUSE OF THE THROMBOCYTOPENIA WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. DEVICE HISTORY REVIEW: THE DEVICE PASSED ALL THE POST STERILE INSPECTION CHECKS.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THE TEAM RECEIVED A R LONG-TERM OUTCOME AND QUALITY INDICATOR (LOQI) DATABASE REPORTED UPON SUBJECT 420-1084 FOR AE #1 OF THROMBOCYTOPENIA. THE RELATIONSHIP LISTED AS POSSIBLY RELATED. THE LOQI STATES: THE PATIENT DEVELOPED THROMBOCYTOPENIA. ADMISSION PLATELETS 82K/UL, NADIR 11 K/UL (ON (B)(6) 2025 (PRIOR TO IMPELLA)), NADIR DURING IMPELLA SUPPORT 20 K/UL (ON (B)(6) 2025). IT WAS LATER REVEALED THAT THE PATIENT HAD HEPARIN-INDUCED THROMBOCYTOPENIA. THE PATIENT WAS SWITCHED TO BIVALIRUDIN. PATIENT SURVIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2655141 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.5 2025611367

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Male Required Intervention