BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA 5.0

    MDR report key: 20664030 · Received November 12, 2024

    Report

    Report Number
    1220648-2024-22936
    Event Type
    Injury
    Date Received
    November 12, 2024
    Date of Event
    September 1, 2024
    Report Date
    December 16, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A.1, A.4 AND A.5 ARE UNKNOWN. D.4 CATALOG NUMBER, SERIAL NUMBER, LOT NUMBER, EXPIRATION DATE AND UNIQUE IDENTIFIER (UDI) # ARE UNKNOWN. D.6A AND D.6B IMPLANT AND EXPLANT DATES ARE UNKNOWN. H.4 DEVICE MANUFACTURE DATE IS UNKNOWN. THE IMPELLA DEVICE WAS DISCARDED BY THE CUSTOMER AND THEREFORE,¿AN EVALUATION OF THE DEVICE WAS NOT POSSIBLE. UPON INVESTIGATION CLOSURE, A SUPPLEMENTAL MANUFACTURER DEVICE REPORT WILL BE FILED. LITERATURE CITATION: FRIED, J., FARR, M., KANWAR, M., URIEL, N., HERNANDEZ-MONTFORT, J., BLUMER, V., LI, S., SINHA, S., GARAN, A., LI, B., HALL, S., HICKEY, G., MAHR, C., NATHAN, S., SCHWARTZMAN, A., KIM, J., TON, V.-K., VISHNEVSKY, O., VOROVICH, E., ¿ KAPUR, N. (2024). CLINICAL OUTCOMES AMONG CARDIOGENIC SHOCK PATIENTS SUPPORTED WITH HIGH-CAPACITY IMPELLA AXIAL FLOW PUMPS: A REPORT FROM THE CARDIOGENIC SHOCK WORKING GROUP. THE JOURNAL OF HEART AND LUNG TRANSPLANTATION, 43(9), 1478¿1488. HTTPS://DOI.ORG/10.1016/J.HEALUN.2024.05.015

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION FOR THE REPORTED ACCESS SITE BLEED, HEMOLYSIS, LIMB ISCHEMIA, STROKE HAS BEEN COMPLETED. THE DEVICE NOR SUFFICIENT CLINICAL INFORMATION WAS RETURNED FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE ACCESS SITE BLEED, HEMOLYSIS, LIMB ISCHEMIA, STROKE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    ABIOMED JAPAN FORWARDED A PUBLICATION FROM NYU COLUMBIA ENTITLED CLINICAL OUTCOMES AMONG CARDIOGENIC SHOCK PATIENTS SUPPORTED WITH HIGH-CAPACITY IMPELLA AXIAL FLOW PUMPS: A REPORT FROM THE CARDIOGENIC SHOCK WORKING GROUP IN WHICH CARDIAC PATIENTS WERE ANALYZED - 6,205 PATIENTS - 754 DID HAVE THE IMPELLA 5.0/5.5 SUPPORT. ADVERSE EVENTS NOTED IN THE MULTICENTER PUBLICATION ARE LIMB ISCHEMIA, BLEEDING, HEMOLYSIS, AND STROKES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    974619 IMPELLA 5.0 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.0

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown Required Intervention| O