BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA 5.5

    MDR report key: 23581944 · Received November 18, 2025

    Report

    Report Number
    1220648-2025-48431
    Event Type
    Injury
    Date Received
    November 18, 2025
    Date of Event
    October 8, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D6B: UPDATED THE EXPLANT DATE. H6: UPDATED CODES BASED ON THE RESULTS OF THE INVESTIGATION. H11: UPDATED BASED ON THE RESULTS OF THE INVESTIGATION. INVESTIGATION SUMMARY: THE DEVICE WAS NOT RETURNED FOR EVALUATION. OPTICAL SENSOR ISSUE: CLINICAL DETAILS REPORT PSNR ALARMS ON 19/OCT AND 26/OCT. DATA LOGS WERE REVIEWED AND THE ALARMS WERE CONFIRMED. THERE WERE A TOTAL OF 3 PSNR TRIGGERS DURING THE CASE. AT ALL THREE INSTANCES, CONTRAST OSCILLATED BETWEEN +/- 3200 AND SNR DROPPED TO ZERO. IN ALL THREE CASES, THE ALARM RESOLVED AND THE PS CALCULATION RETURNED. THIS IS A KNOWN CONSOLE ISSUE. PRODUCT WAS NOT RETURNED FOR INVESTIGATION. BASED ON THE PATTERN NOTED IN DATA LOG REVIEW, THERE WAS NO PROBLEM FOUND WITH THE PUMP. EPISTAXIS/HEMOPTYSIS: CLINICAL DETAILS REPORT THAT THE PATIENT HAD BLEEDING FROM THE NOSE AND WAS COUGHING UP BLOOD ON 8/OCT. THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. THE PUMP PASSED ALL POST-STERILE INSPECTION CHECKS.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT IMPLANTED WITH AN IMPELLA 5.5 COUGHED UP BLOOD AND WAS BLEEDING FROM THE NOSE. THE ISSUE WAS RESOLVED WITH SYSTEMIC ANTICOAGULATION AND TRANSFUSION OF ONE UNIT OF PACKED RED BLOOD CELLS. ADDITIONALLY, THE IMPELLA GENERATED A PLACEMENT SIGNAL NOT RELIABLE ALARM. IMPELLA SUPPORT CONTINUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1644168 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.5 2026731297 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention