BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 25150921 · Received May 12, 2026

    Report

    Report Number
    1220648-2026-07776
    Event Type
    Injury
    Date Received
    May 12, 2026
    Date of Event
    May 7, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED D9 WAS UPDATED. THE INVESTIGATION IS UNDERWAY ONCE COMPLETED A SUPPLEMENTAL WILL BE SENT.

    Additional Manufacturer Narrative · 0

    A2. PATIENT AGE AT THE TIME OF EVENT IS UNKNOWN. 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 MALE PATIENT PRESENTING WITH ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK (AMI/CGS). PATIENT'S COMORBIDITIES WERE UNKNOWN. THE PATIENT¿S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS IDENTIFIED AS SCAI SHOCK STAGE E. HEMOLYSIS WAS NOTED; HOWEVER, THE ETIOLOGY WAS UNCLEAR, AND IT IS UNKNOWN WHETHER IT WAS DUE TO IMPELLA SUPPORT, VA ECMO, OR CRRT. ECHOCARDIOGRAPHY DEMONSTRATED THE IMPELLA POSITIONED DEEP AT 5 CM, WHICH WAS SUBSEQUENTLY REPOSITIONED TO 3.5 CM. THE PATIENT RECEIVED 1 UNIT OF PACKED RED BLOOD CELLS AND 1 UNIT OF PLATELETS. THE POSITIONING ISSUE HAD NO IMPACT ON THE PATIENT'S HEMODYNAMICS, AND THE PATIENT SURVIVED TO EXPLANT. HEMOLYSIS MAY OCCUR IN THE SETTING OF CONCURRENT IMPELLA SUPPORT WITH VA ECMO AND CRRT, AND MAY BE INFLUENCED BY THE DEEP DEVICE POSITION OBSERVED ON ECHOCARDIOGRAPHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195674 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026792139 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1