BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA CP

    MDR report key: 23210139 · Received October 3, 2025

    Report

    Report Number
    1220648-2025-47152
    Event Type
    Injury
    Date Received
    October 3, 2025
    Date of Event
    September 4, 2025
    Report Date
    October 2, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: E4, H6 MEDICAL DEVICE PROBLEM CODE A090814 WAS ERRONEOUSLY ENTERED ON THE INITIAL MANUFACTURER DEVICE REPORT THE INVESTIGATION OF THE REPORTED FAILURE MODE HAS BEEN COMPLETED. NO PRODUCT WAS RETURNED. DEVICE IN WRONG POSITION AND DIFFICULT TO PLACE OR POSITION - THE CAUSE OF THE DEVICE IN WRONG POSITION AND DIFFICULT TO PLACE WAS NOT DETERMINED DUE TO NO PRODUCT RETURNED AND INSUFFICIENT CLINICAL DETAILS. MECHANICAL INTERACTION WITH BLOOD - DATA LOGS WERE NOT RECOVERED. THE CAUSE OF THE MECHANICAL INTERACTION WITH BLOOD WAS NOT DETERMINED DUE TO NO PRODUCT RETURNED, NO DATA LOGS RECOVERED, AND INSUFFICIENT CLINICAL DETAILS. LOW OR BLOCKED PUMP FLOW -THE CAUSE OF THE LOW FLOWS WAS NOT DETERMINED DUE TO NO PRODUCT RETURNED, NO DATA LOGS RECOVERED, AND INSUFFICIENT CLINICAL DETAILS. DEVICE HISTORY REVIEW: THE DEVICE PASSED ALL THE POST STERILE INSPECTION CHECKS.

    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.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED A PATIENT IMPLANTED WITH AN IMPELLA CP. AFTER IMPLANT, THE PUMP SHOWED SHALLOW ON TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) AND FACING TOWARDS THE POSTERIOR WALL. ATTEMPTED TO REPOSITION BUT WERE UNSUCCESSFUL, AS THE PUMP REMAINED SHALLOW AND FACING THE MITRAL VALVE. THE PURGE WAS CHANGED TO BICARBONATE. THE SECOND DAY OF SUPPORT, THE PUMP WAS REPOSITIONED AFTER FLOWS DROPPED. REPOSITIONING SUCCESSFULLY IMPROVED FLOWS. ON THE FINAL DAY OF SUPPORT, THE PATIENT HAD ACUTE AGITATION AND COUGHING EVENT WITH NEAR SUDDEN FRANK HEMATURIA. LACTATE WAS SENT AND HEMOLYZED, FLOWS DROPPED, AND THE DEVICE WAS SHALLOW ON TEE, WITH THE INFLOW JUST BELOW THE LEVEL OF THE AORTIC VALVE ANNULUS. ATTEMPTED TO REPOSITION BUT THE PUMP CONTINUED TO BE TETHERED TO THE MITRAL VALVE APPARATUS. THROUGHOUT SUPPORT, THE PUMP HAD POOR POSITIONING, CONSISTENTLY MOVING TOWARDS THE MITRAL VALVE. THE PHYSICIAN ELECTED TO PROCEED WITH EXPLANT IN THE SETTING OF THE IMPROVED LEFT VENTRICLE FUNCTION. THE IMPELLA CP WAS REMOVED IN SETTING OF HEMOLYSIS AND POOR POSITIONING CONSISTENTLY TOWARDS THE MITRAL VALVE. THE PHYSICIAN ELECTED TO CONVERT TO INTRA-AORTIC BALLOON PUMP FOR CONTINUED SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2434752 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2025502501

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention