BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA

    MDR report key: 25315318 · Received May 28, 2026

    Report

    Report Number
    1220648-2026-08202
    Event Type
    Malfunction
    Date Received
    May 28, 2026
    Date of Event
    May 21, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4. LOT, SERIAL, AND EXPIRATION DATE ARE UNKNOWN. A4 WEIGHT IS 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. RELATED MEDICAL DEVICE REPORTS: THIS IMPELLA PURGE CASSETTE DEVICE REPORT IS ONE OF TWO DEVICES ASSOCIATED WITH THE EVENT. REFER TO THE RELATED MANUFACTURER REPORT NUMBER AS NOTED IN SECTION H10 FOR THE MEDICAL DEVICE REPORT ON THE IMPELLA CP.

    Description of Event or Problem · 0

    CLINICAL NARRATIVE: AN IMPELLA CP DEVICE WAS INSERTED VIA THE RIGHT FEMORAL ARTERY IN A 77-YEAR-OLD MALE PATIENT PRESENTING WITH HIGH-RISK PERCUTANEOUS CORONARY INTERVENTION (HRPCI). 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 A. THE PHYSICIAN FLUSHED THE INTRODUCER PRIOR TO INSERTING THE IMPELLA, WITH AN ACT OF 261. THE IMPELLA CROSSED THE AORTIC VALVE WITHOUT ISSUE. AFTER REMOVING THE WIRE AND TURNING THE IMPELLA ON, A HIGH PURGE FLOW ALARM WAS TRIGGERED, WITH A PURGE FLOW OF 30 ML/HR. THE LINE WAS ASSESSED AND NO KINKS WERE IDENTIFIED. THE PHYSICIAN DECIDED TO REMOVE THE PUMP AND CASSETTE AND REPLACE THEM WITH A SECOND IMPELLA CP. THE IMPELLA CP DEVICE WAS EXCHANGED FOR ANOTHER IMPELLA CP WITHOUT ANY OBSERVED IMPACT ON THE PATIENT¿S HEMODYNAMIC STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584341 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648

    Patients

    Seq Age Sex Outcome Treatment
    1