BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 25229739 · Received May 20, 2026

    Report

    Report Number
    1220648-2026-08017
    Event Type
    Death
    Date Received
    May 20, 2026
    Date of Event
    May 13, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502010985
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A5 AND A6 ARE 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

    IMPELLA CP WAS INSERTED VIA THE RIGHT FEMORAL ARTERY IN AN 81 YEAR-OLD MALE PATIENT PRESENTING WITH ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK. THE PATIENT¿S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY AND INTERVENTIONS SHOCK STAGE E. DURING SUPPORT, CONNECTION ISSUES WERE REPORTED WITH THE AUTOMATED IMPELLA CONTROLLER, WITH THE CONTROLLER REMAINING ONLINE BUT NO PUMP DATA AVAILABLE AND NO CASE REVIEW POSSIBLE. THE OUTCOME WAS WITHDRAWAL OF CARE. THE IMPELLA CONNECT ISSUE HAD NO CLINICAL CONSEQUENCE TO THE PATIENT. THE PATIENT¿S DEATH OCCURRED WHEN CARE WAS WITHDRAWN. UNDERLYING SCAI STAGE E MAY ALSO BE A CONTRIBUTING FACTOR TO THE PATIENT'S OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388880 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 1342118 00813502010985

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Death