BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 25317063 · Received May 28, 2026

    Report

    Report Number
    1220648-2026-08226
    Event Type
    Injury
    Date Received
    May 28, 2026
    Date of Event
    May 21, 2026
    Report Date
    May 28, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    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

    AN IMPELLA CP WAS INSERTED VIA THE RIGHT FEMORAL ARTERY IN A 53-YEAR-OLD FEMALE PATIENT FOR THE INDICATION OF ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK (AMI/CGS). THE PATIENT'S COMORBIDITIES WERE NOT REPORTED, AND THE CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS CONSISTENT WITH SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY AND INTERVENTIONS (SCAI) STAGE B CARDIOGENIC SHOCK. DURING IMPELLA CP SUPPORT, IT WAS REPORTED THAT THE PATIENT DEVELOPED ISCHEMIA OF THE RIGHT LOWER EXTREMITY, WITH NO DOPPLER PULSES DETECTED AND THE RIGHT FOOT APPEARING MOTTLED. DUE TO THE REPORTED LIMB ISCHEMIA, THE PATIENT WAS TRANSFERRED FOR ESCALATION OF THERAPY TO IMPELLA 5.5 AND CONTINUED CARE. THE IMPELLA CP DEVICE WAS SUBSEQUENTLY EXPLANTED, AND THE PATIENT SURVIVED TO DEVICE EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531210 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027845451 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1