BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA CP

    MDR report key: 23750714 · Received December 8, 2025

    Report

    Report Number
    1220648-2025-48836
    Event Type
    Injury
    Date Received
    December 8, 2025
    Date of Event
    November 9, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1 ADDED ZIP CODE EXTENSION AS IT WAS OMITTED FROM THE PREVIOUSLY SUBMITTED REPORTS. H6 B13 CODE WAS ADDED AS IT WAS OMITTED FROM THE PREVIOUSLY SUBMITTED REPORTS. TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS AND COMPONENT CODES WERE UPDATED ACCORDINGLY BASED ON THE COMPLETED INVESTIGATION. INVESTIGATION SUMMARY: THE INVESTIGATION HAS BEEN COMPLETED. NO PRODUCT WAS RETURNED. HEMOLYSIS: NO LOGS ARE AVAILABLE. THE CAUSE OF HEMOLYSIS CANNOT BE DETERMINED SINCE INSUFFICIENT CLINICAL DETAILS WERE PROVIDED. DEVICE IN WRONG POSITION: THE CAUSE OF THE POSITIONING ISSUE WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO ADD AN H6 DEVICE PROBLEM CODE THAT WAS OMITTED FROM THE INITIAL REPORT. H6 MEDICAL DEVICE PROBLEM CODE A01 (PATIENT¿DEVICE INTERACTION PROBLEM) HAS BEEN ADDED.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED A PATIENT STARTED TO HAVE SEVERE 10/10 CHEST PAIN. THE PATIENT CALLED EMERGENCY MEDICAL SERVICES AND WAS TRANSPORTED TO THE HOSPITAL. AN ELECTROCARDIOGRAM REVEALED ANTERIOLATERAL ST-ELEVATION MYOCARDIAL INFARCTION. THE PATIENT WAS TAKEN TO THE CATH LAB. AN ANGIOGRAM REVEALED OCCLUDED LEFT ANTERIOR DESCENDING ARTERY AT THE OSTIUM WITH HEAVY THROMBUS BURDEN. THERE WAS LEFT VENTRICULAR EJECTION FRACTION AROUND 15%. LEFT VENTRICULAR END-DIASTOLIC PRESSURE IS 41 MMHG. DECISION MADE FOR IMPELLA CP. THE IMPELLA CP WAS PLACED IN LEFT VENTRICLE WITHOUT ISSUE. WHILE ON SUPPORT, IT WAS REPORTED THAT THE PATIENT HAD DARK URINE, WITH HEMOLYSIS. AN ECHOCARDIOGRAM WAS DONE AT BEDSIDE WITH INITIAL MEASUREMENT 5.5 AND WAS MOVED BACK TO 4.2, PIG-TAIL TOWARD APEX. THE PATIENT REMAINED ON SUPPORT FOR TWO DAYS UNTIL EXPLANATION AND THE PATIENT SURVIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487213 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2026769625 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention