BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA

    MDR report key: 24601612 · Received March 15, 2026

    Report

    Report Number
    1220648-2026-05285
    Event Type
    Malfunction
    Date Received
    March 15, 2026
    Date of Event
    March 5, 2026
    Report Date
    May 13, 2026
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502011876
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN
    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

    THE INVESTIGATION FOR THE PLACEMENT SIGNAL ISSUE HAS BEEN COMPLETED. BASED ON THE DATA LOG ANALYSIS OF LOW SNR ACROSS MULTIPLE DEVICES, THE CAUSE OF THE PLACEMENT SIGNAL ISSUE APPEARS TO BE POTENTIALLY CONSOLE RELATED.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT A PATIENT IN CARDIOGENIC SHOCK SECONDARY TO AN ACUTE MYOCARDIAL INFARCTION WAS IMPLANTED WITH AN IMPELLA CP DEVICE FOR TEMPORARY MECHANICAL CIRCULATORY SUPPORT. THE DEVICE WAS PERCUTANEOUSLY INSERTED VIA THE RIGHT FEMORAL ARTERY. AT THE TIME OF IMPELLA SUPPORT INITIATION, THE PATIENT WAS CLASSIFIED AS SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY AND INTERVENTIONS (SCAI) STAGE E CARDIOGENIC SHOCK, WITH SUBSEQUENT IMPROVEMENT TO SCAI STAGE C DURING SUPPORT. ON DAY SEVEN OF SUPPORT, A ¿PLACEMENT SIGNAL NOT RELIABLE¿ ALARM OCCURRED. THE PATIENT CONTINUED TO RECEIVE SUPPORT, AND NO ADDITIONAL ISSUES OR CONCERNS RELATED TO DEVICE SUPPORT WERE REPORTED. THE DEVICE WAS SUBSEQUENTLY WEANED AND EXPLANTED SUCCESSFULLY, AND THE PATIENT SURVIVED. IT WAS FURTHER REPORTED THAT NO PATIENT HARM OCCURRED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51191 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. 2026675006 00813502011876

    Patients

    Seq Age Sex Outcome Treatment
    1