BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 25145924 · Received May 12, 2026

    Report

    Report Number
    1220648-2026-07749
    Event Type
    Death
    Date Received
    May 12, 2026
    Date of Event
    May 6, 2026
    Report Date
    May 14, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502010022
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED INFORMATION: B2. ADDED DEATH AND DATE OF DEATH. B5. CLINICAL NARRATIVE UPDATED. D6B. EXPLANT DATE ADDED. H1. CHANGED TO DEATH. H6. IMPACT CODE CHANGED TO F02.

    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 75-YEAR-OLD MALE PATIENT PRESENTING WITH ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK (AMI/CGS). THE PATIENT HAD A HISTORY OF KNOWN CORONARY ARTERY DISEASE. THE PATIENT¿S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS IDENTIFIED AS SCAI SHOCK STAGE E. DURING SUPPORT, A CONTROLLER ERROR OCCURRED. THE ISSUE WAS CLEARED AFTER CONSULTATION WITH CSC, AND IT WAS ADVISED TO LEAVE THE DEVICE IN THE CONTROLLER FOR THE TIME BEING. CARE WAS SUBSEQUENTLY WITHDRAWN, AND THE PATIENT EXPIRED. THE DEVICE WILL BE CONSERVATIVELY REPORTED FOR DEATH; HOWEVER, THE DEATH IS MOST LIKELY ATTRIBUTED TO THE PATIENT¿S UNDERLYING CRITICAL CLINICAL CONDITION AS THEY PRESENTED IN SCAI SHOCK STAGE E.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT A PATIENT WAS IMPLANTED WITH AN IMPELLA CP DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. DURING SUPPORT, THERE WAS AN AUTOMATED IMPELLA CONTROLLER (AIC) CONTROLLER ERROR. IT WAS CLEARED AND THE CUSTOMER SERVICE CENTER SAID TO LEAVE THE PUMP IN THE CONTROLLER. THE CONTROLLER AND PUMP NEEDED TO BE RETURNED. AT THIS TIME, THE PATIENT IS STILL ON SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66069 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 1132873 00813502010022

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Death