BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA CP

    MDR report key: 20988033 · Received December 20, 2024

    Report

    Report Number
    1220648-2024-25013
    Event Type
    Malfunction
    Date Received
    December 20, 2024
    Date of Event
    December 5, 2024
    Report Date
    January 22, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION FOR THE OPTICAL SIGNAL ISSUE HAS BEEN COMPLETED. THE PUMP WAS RETURNED FOR INVESTIGATION. NO PHYSICAL ABNORMALITIES WERE REPORTED ON THE RETURNED PRODUCT. THE PUMP PASSED THE LASER CONTINUITY TEST FOR THE OPTICAL LINE. ALL THE 5S SNR PARAMETERS WERE WITHIN THE SPECIFIED RANGE. THE PUMP WAS TESTED IN A BUCKET OF WATER AND RAN AS INTENDED. THE DATA LOG SHOWS THAT THE PLACEMENT SIGNAL REACHED 3000 WITH PSNR, THEN AFTER THE PUMP WAS INSERTED INTO THE PATIENT'S BODY, THE SNR TRENDED FROM 4000 TO 0. THE SNR AND CONTRAST REMAINED AT VERY LOW LIMITS AND TRENDY THROUGHOUT THE CASE, WITHOUT OBTAINING A PLACEMENT SIGNAL. THE CAUSE OF THE OPTICAL SIGNAL ISSUE WAS MOST LIKELY PATIENT CONDITION RELATED, BASED ON RETURNED PRODUCT INVESTIGATION AND DATA LOG REVIEW.

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE HAS BEEN RETURNED, AND AN EVALUATION IS UNDERWAY. UPON COMPLETION OF OUR ANALYSIS, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    THE COMPLAINANT HAD PLACED AN IMPELLA CP PUMP FOR SUPPORT OF A POST-OPERATIVE CORONARY ARTERY BYPASS GRAFT/AORTIC VALVE REPAIR PATIENT. THE PUMP WAS PLACED AS CARE ESCALATION FROM AN INTRA-AORTIC BALLOON PUMP AND THE TEAM CONSIDERED IMPELLA CP-RP SUPPORT. THE IMPELLA CP WAS EXPLANTED AND REPLACED AFTER JUST OVER ONE HOUR OF SUPPORT DUE TO LOST PLACEMENT SIGNAL. THE PATIENT SURVIVED THE EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2169861 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2025531185

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female