BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 25330572 · Received May 29, 2026

    Report

    Report Number
    1220648-2026-08260
    Event Type
    Injury
    Date Received
    May 29, 2026
    Date of Event
    May 22, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION.

    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

    AN IMPELLA CP WAS INSERTED VIA THE RIGHT FEMORAL ARTERY TO SUPPORT THE 74 YEAR OLD MALE PATIENT WHO HAD BEEN ADMITTED IN WITH INDICATION OF ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK, PRESENTING IN SCAI STAGE E SHOCK. THE CP WAS INSERTED AND WAS SUPPORTING WHEN THERE WAS SUCTION IN THE EVENING AFTER INSERTION. THIS PROMPTED THE TEAM TO REPOSITION THE PUMP. THE FOLLOWING MORNING THERE WERE SIGNS OF HEMOLYSIS IN URINE COLOR CHANGE. AGAIN THE TEAM MADE DECISION TO PERFORM ECHO IMAGING TO ASSESS PUMP POSITION. AFTER JUST UNDER 2 DAYS THE TEAM WEANED AND EXPLANTED THE PUMP AND THE PATIENT SURVIVED. AT THE TIME OF WEANING THE HEMOLYSIS WAS PERSISTENT. WHILE ON SUPPORT THE DEVICE FUNCTIONED AS EXPECTED, P-9 WITH 3.6L/MIN FLOW WITH D5W WITH SODIUM BICARBONATE IN THE PURGE SOLUTION AND HEPARIN SYSTEMICALLY. HEMOLYSIS MAY OCCUR IN THE SETTING OF ANTICOAGULATION REQUIREMENTS AND MAY BE INFLUENCED BY PATIENT-SPECIFIC FACTORS SUCH AS UNDERLYING CARDIOGENIC SHOCK AND HIGH SUPPORT LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566464 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027854124 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1