BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 25045522 · Received April 30, 2026

    Report

    Report Number
    1220648-2026-07284
    Event Type
    Injury
    Date Received
    April 30, 2026
    Date of Event
    March 4, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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.

    Description of Event or Problem · 0

    AN IMPELLA 5.5 WAS INSERTED VIA THE DIRECT SURGICAL APPROACH TO PROVIDE HEMODYNAMIC SUPPORT TO THE SURGICAL PATIENT WHO WAS ADMITTED IN FOR AN AORTIC VALVE REPLACEMENT AND ASCENDING AORTA ANEURYSM. THE PATIENT HAD BEEN ADMITTED IN WITH SCAI STAGE D SHOCK AND WAS ON INOTROPES AND VASOPRESSORS PRIOR TO THE PUMP PLACEMENT. THE SURGERY WAS PERFORMED AND HEMOSTASIS WAS OBTAINED WITH PURSE STRING SUTURES AT THE SKIN. THE TEAM FOUND THE NEED TO ADMINISTER PROTAMINE AND OBSERVE THE HEMOSTASIS FOR APPROXIMATELY 2 HOURS. THE PATIENT CONDITION WAS NOTED TO BE POOR AND IN A COAGULOPATHY. THE HEMOGLOBIN DROPPED FROM 11.7G/DL TO 7.5G/DL. THEY HAD TO INFUSE BACK TO THE PATIENT FRESH FROZEN PLASMA, RED BLOOD CELLS, AND CRYO. THE PUMP SUPPORTED FOR OVER 7 DAYS AND WAS SUCCESSFULLY WEANED AND EXPLANTED. THE PATIENT SURVIVED. BLEEDING IN THIS CLINICAL CONTEXT IS A KNOWN AND EXPECTED RISK ASSOCIATED WITH IMPELLA 5.5 SUPPORT, PARTICULARLY IN THE SETTING OF RECENT MAJOR CARDIAC SURGERY, DIRECT SURGICAL AORTIC ACCESS, PERIOPERATIVE COAGULOPATHY, AND CRITICAL ILLNESS. ADDITIONAL CONTRIBUTING FACTORS MAY INCLUDE LARGE-BORE ARTERIAL ACCESS, SURGICAL MANIPULATION, AND ONGOING TRANSFUSION REQUIREMENTS NECESSARY FOR HEMODYNAMIC MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162895 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026814167 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1