BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 25170800 · Received May 14, 2026

    Report

    Report Number
    1220648-2026-07807
    Event Type
    Injury
    Date Received
    May 14, 2026
    Date of Event
    May 8, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ABIOMED INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ABIOMED INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    CLINICAL NARRATIVE: AN IMPELLA CP DEVICE WAS INSERTED VIA THE RIGHT FEMORAL ARTERY IN A (B)(6)-YEAR-OLD FEMALE PATIENT FOR ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK, PRESENTING IN SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY AND INTERVENTIONS (SCAI) STAGE A SHOCK, DURING PROTECTED PERCUTANEOUS CORONARY INTERVENTION (PROTECTED PCI). DURING IMPELLA CP SUPPORT, BLOOD WAS NOTED IN THE URINE. PUMP POSITION WAS CONFIRMED TO BE APPROPRIATE ON IMAGING AT THE TIME OF REPORTED EVENT; HOWEVER, IT IS UNKNOWN WHETHER THIS RESOLVED. NO ADDITIONAL CLINICAL DETAILS WERE PROVIDED REGARDING ASSOCIATED LABORATORY FINDINGS, IMAGING, DEVICE POSITION, ANTICOAGULATION STATUS, OR SUBSEQUENT CLINICAL MANAGEMENT. THE PATIENT SURVIVED TO EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593971 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027869929 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1