BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA CP

    MDR report key: 21167810 · Received January 16, 2025

    Report

    Report Number
    1220648-2025-25611
    Event Type
    Death
    Date Received
    January 16, 2025
    Date of Event
    December 26, 2024
    Report Date
    April 3, 2025
    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
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE HAS NOT BEEN RECEIVED FROM THE CUSTOMER, THEREFORE, INVESTIGATION OF THE DEVICE HAS NOT BEEN POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION FOR THE LOW PUMP FLOW HAS BEEN COMPLETED. NO PRODUCT WAS RETURNED. THERE WAS NO LOW PUMP FLOW SEEN IN THE DATA LOGS. NO MOTOR CURRENT SPIKE, PLACEMENT SIGNAL TREND, OR POSITIONING ALARMS SEEN. THE LOGS ONLY GO FROM 12/25 2:44 TO 12:25 3:19. DUE TO INSUFFICIENT INFORMATION, THE ROOT CAUSE OF THE LOW PUMP FLOW CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    B.1 REVISED FROM THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-25611 TO REFLECT BOTH ADVERSE EVENT AND PRODUCT PROBLEM. B.2 REVISED FROM THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-25611 TO REFLECT THE PATIENT OUTCOME DEATH AND ADDED DATE OF DEATH. B.5 ADDED PATIENT OUTCOME INFORMATION AS IT WAS INADVERTENTLY OMITTED FROM THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-25611. D.6B REVISED EXPLANT DATE WAS PREVIOUSLY ENTERED INCORRECTLY ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-25611. E.4 SHOULD HAVE BEEN LEFT BLANK ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-25611 AS IT IS UNKNOWN IF THE INITIAL REPORTER ALSO SENT THE REPORT TO THE FOOD AND DRUG ADMINISTRATION. H.1 TYPE OF REPORTABLE EVENT WAS REVISED FROM THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-25611 TO REFLECT THE PATIENT OUTCOME OF DEATH. H.6 HEALTH EFFECT - IMPACT CODE 1802 WAS ADDED AS IT WAS INADVERTENTLY OMITTED FROM THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-25611.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT THE PATIENT ON IMPELLA CP SUPPORT WAS DECOMPENSATING AS IMPELLA WAS NOT OFFLOADING THE LEFT VENTRICLE. THE CP WAS EXCHANGED FOR THE IMPELLA 5.5. THE PATIENT IS STABLE AND SURVIVED THE EVENT.

    Description of Event or Problem · 0

    THE DECISION WAS MADE TO WITHDRAW CARE AND THE PATIENT EXPIRED. IT IS UNKNOWN IF THE USE OF THE IMPELLA WAS RELATED TO THE PATIENT'S DEATH. THUS, THERE IS NOT ENOUGH EVIDENCE TO EXCLUDE IMPELLA AS AN ASSOCIATED FACTOR IN THE PATIENT'S OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1510320 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2025563799 00813502011876

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Death