BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 24309754 · Received February 10, 2026

    Report

    Report Number
    1220648-2026-02821
    Event Type
    Death
    Date Received
    February 10, 2026
    Date of Event
    November 28, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6 CODES HAVE BEEN UPDATED.

    Additional Manufacturer Narrative · 0

    PPAE (ARRHYTHMIA) : THE ROOT CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Additional Manufacturer Narrative · 0

    B1. BRAND NAME CORRECTED. D4. CATALOG AND SERIAL CORRECTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN PROVIDED IN B5 (EVENT DESCRIPTION) AND UDI (D4). 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.

    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.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION INDICATES THAT LIDOCAINE INFUSION WAS ADDED AND MEDICATIONS WERE OPTIMIZED.

    Description of Event or Problem · 0

    32-YEAR-OLD MALE PATIENT WITH STAGE D CARDIOGENIC SHOCK ON ECMO AS THE PRIMARY SUPPORT DEVICE, IMPLANTED WITH IMPELLA CP VIA THE LEFT FEMORAL ARTERY FOR LEFT VENTRICULAR UNLOADING. PATIENT EXPERIENCED RUNS OF VENTRICULAR TACHYCARDIA, WHICH RESOLVED AFTER RECEIVING A SHOCK. ON DAY 7, ECMO WAS DECANNULATED, AND IMPELLA CP THERAPY CONTINUED. ON DAY 9, PATIENT WAS NOT PROGRESSING AND CARE WAS WITHDRAWN. THE DEATH IS MOST LIKELY CONTRIBUTED TO PATIENT'S INITIAL CRITICAL CLINICAL PRESENTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246348 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 PUMP 381 PUMP SET (US) 2026764274 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Male Required Intervention| D