BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA CP

    MDR report key: 19583615 · Received June 21, 2024

    Report

    Report Number
    1220648-2024-12591
    Event Type
    Malfunction
    Date Received
    June 21, 2024
    Date of Event
    June 9, 2024
    Report Date
    August 5, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS DISCARDED BY THE CUSTOMER AND THEREFORE, AN EVALUATION OF THE DEVICE WAS NOT POSSIBLE. UPON INVESTIGATION CLOSURE, A SUPPLEMENTAL MDR WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF POSITIONING ISSUES HAS BEEN COMPLETED. THE IMPELLA DEVICE WAS NOT RETURNED FOR EVALUATION. THE CAUSE OF THE POSITIONING ISSUE MOST LIKELY WAS USE RELATED DUE TO IMPROPER TECHNIQUE. THE FOLLOWING HAVE BEEN REPORTED INCORRECTLY OR MISSING FROM MANUFACTURER DEVICE REPORT 1220648-2024-12591: E4 SHOULD HAVE BEEN LEFT BLANK, G1 REPORTING CONTACT FAX NUMBER MISSING.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED A PATIENT IN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK WAS IMPLANTED WITH AN IMPELLA CP DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. THE IMPELLA CP HAD BEEN PLACED THROUGH RIGHT COMMON FEMORAL ARTERY USING 25CM PEEL-AWAY SHEATH. WAVEFORMS AND AUTOMATED IMPELLA CONTROLLER (AIC) WAS SHOWING IMPELLA IN AORTA, RUNNING ON P-9 WITH FLOWS >4.5L. THE PATIENT¿S BLOOD PRESSURE WAS DECREASED SO THE P-LEVEL WAS BROUGHT DOWN TO P-2. MD STATED THAT THE IMPELLA CP MOVED WHEN PEEL AWAY WAS REMOVED. THE IMPELLA WAS REMOVED DUE TO POOR POSITIONING AND A NEW CP WAS SUCCESSFULLY PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201818 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2025490195 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female