BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA CP

    MDR report key: 18005599 · Received October 25, 2023

    Report

    Report Number
    1220648-2023-04566
    Event Type
    Death
    Date Received
    October 25, 2023
    Date of Event
    May 30, 2023
    Report Date
    September 19, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502011876
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FILE IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF HISTORICAL RECORDS AFTER WHICH MEDICAL SAFETY HAS UPDATED THE REPORT TYPE. CORRECTED INFORMATION FOR THE INITIAL MFR 1220648-2023-045 WAS PROVIDED IN SECTIONS B2, B5, H1, AND H6. NOTE: CORRECTED INFORMATION PROVIDED IN H6 IS AN ADDITION TO PREVIOUS CODING.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION INTO THE REPORTED "SATURATED FLOW" HAS BEEN COMPLETED. PRODUCT WAS RETURNED FOR INVESTIGATION. THE DEVICE WAS INSPECTED AND FOUND THAT BIOMATERIAL WAS NEAR THE IMPELLER OF THE PUMP. THERE WERE NO OTHER ABNORMALITIES FOUND. WHILE REVIEWING IMPELLA CONNECT LOGS OF THE PUMP AT P4 SHOWED POSSIBLE FLOW SATURATION. PATIENT'S ACT REMAINED HIGH ONCE IN THE UNIT SO HEPARIN WAS NOT STARED IN THE PURGE. THE PUMP EXPERIENCED PUMP SATURATION AND PUMP STOPPAGE. THE PUMP WAS ABLE TO RESTARTED AT P3 AND MAINTAINED AT P3 OVERNIGHT. THE INVESTIGATION DETERMINED THAT THE ROOT CAUSE OF THE ISSUE WAS BIOMATERIAL NEAR THE IMPELLER. INSTRUCTIONS FOR USE FOR THE RELATED EVENT ARE AS FOLLOWS: "MAINTAINING ACT AT OR ABOVE 250 SECONDS WILL HELP PREVENT A THROMBUS FROM ENTERING THE CATHETER AND CAUSING A SUDDEN STOP ON STARTUP.¿

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION NOTED THE PATIENT WAS MADE A DO NOT RESUSCITATE, CARE WAS WITHDRAWN, AND THE PATIENT EXPIRED. MEDICAL SAFETY REVIEW OF THE EVENT NOTED THERE IS NOT ENOUGH INFORMATION TO EXCLUDE THE IMPELLA DEVICE AS AN ASSOCIATED FACTOR IN THE PATIENT'S DEMISE.

    Description of Event or Problem · 0

    THE COMPLAINANT HAD AN IMPELLA CP SUPPORT FOR A 68-YEAR-OLD FEMALE PATIENT WITH SEVERE MITRAL REGURGITATION (MR). THE IMPELLA CP WAS PLACED BUT, HAD SATURATED FLOWS. THE SATURATED FLOWS DID NOT PROMPT THE PUMP TO BE REPLACED OR EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1433069 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2023277382 00813502011876

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Death