BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24788418 · Received April 6, 2026

    Report

    Report Number
    1220648-2026-06400
    Event Type
    Injury
    Date Received
    April 6, 2026
    Date of Event
    March 26, 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
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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.

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION HAS BEEN PROVIDE DIN H1. UPON FURTHER REVIEW, THE REPORT TYPE SELECTED IN THE PREVIOUS SUBMISSION WAS DETERMINED TO BE INCORRECT AND THE REPORT HAS BEEN UPDATED ACCORDINGLY TO ACCURATELY REFLECT THE APPROPRIATE REPORTABLE EVENT CATEGORY.

    Description of Event or Problem · 0

    CLINICAL NARRATIVE: A 71-YEAR-OLD FEMALE WITH AN INDICATION FOR USE OF ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK (PRE SUPPORT CLINICAL CONDITION CONSISTENT WITH SCAI SHOCK STAGE E) WAS SUPPORTED WITH AN IMPELLA SYSTEM. THE IMPELLA DEVICE WAS IMPLANTED ON (B)(6) 2026 AT 10:23 AM VIA A RIGHT AXILLARY/SUBCLAVIAN SURGICAL ARTERIAL APPROACH. DURING ONGOING SUPPORT, A CONTROLLER FAILURE ALERT WAS REPORTED ON THE AUTOMATED IMPELLA CONTROLLER (AIC). THE ALERT WAS IDENTIFIED AS A FAILURE ALARM INVOLVING THE AIC SYSTEM (INCLUSIVE OF PUMP, PURGE, AND BATTERY). IN RESPONSE TO THE CONTROLLER FAILURE ALERT, THE AFFECTED AIC WAS ELECTIVELY REMOVED FROM SERVICE AND REVISED SUCCESSFULLY TO ANOTHER AIC. THE AUTOMATED IMPELLA CONTROLLER WILL BE CONSERVATIVELY REPORTED FOR HEMODYNAMIC INSTABILITY DUE TO TEMPORARY HEMODYNAMIC SUPPORT INTERRUPTION DURING THE EXCHANGE; HOWEVER, THE EXCHANGE WAS PERFORMED WITH NO CONSEQUENCE TO THE PATIENT AND SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100017 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 1261094 00813502010022

    Patients

    Seq Age Sex Outcome Treatment
    1