BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA CP

    MDR report key: 23104251 · Received September 20, 2025

    Report

    Report Number
    1220648-2025-46654
    Event Type
    Malfunction
    Date Received
    September 20, 2025
    Date of Event
    August 21, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6 COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS CODES HAVE BEEN UPDATED TO REFLECT INVESTIGATION CLOSURE. INVESTIGATION SUMMARY : UNABLE TO DELIVER OR ADVANCE : THE CAUSE OF THE DELIVER ISSUE WAS DETERMINED TO BE PATIENT CONDITION AS THE PATIENT HAD DIFFICULT VASCULATURE PREVENTING SUCCESSFUL DELIVERY OF IMPELLA. DEVICE HISTORY LOT : DEVICE LOT : 1943288. DEVICE HISTORY REVIEW : THE PUMP S/N: 608638 PASSED ALL THE POST STERILE INSPECTION CHECKS.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED A PATIENT IN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK WAS BEING IMPLANTED WITH AN IMPELLA CP DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. IT WAS REPORTED THAT THE IMPELLA WAS INSERTED BUT SUBSEQUENTLY ABORTED DUE TO PATIENT'S VASCULATURE. THERE WAS NO PATIENT HARM REPORTED, AND THE PATIENT OUTCOME WAS NOTED TO BE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1992389 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2026698845

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male