BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 25151020 · Received May 12, 2026

    Report

    Report Number
    1220648-2026-07781
    Event Type
    Injury
    Date Received
    May 12, 2026
    Date of Event
    May 7, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED STATING THERE WAS CONCERN FOR HEMOLYSIS AS THE PATIENT'S HEMOGLOBIN DROPPED AND THE LDH LEVEL WAS HIGH. H6, HEALTH EFFECT CLINICAL CODE: E0303 HAS BEEN ADDED.

    Additional Manufacturer Narrative · 0

    A4, A5, AND A6 ARE 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.

    Description of Event or Problem · 0

    AN IMPELLA 5.5 WAS INSERTED VIA THE DIRECT SURGICAL ACCESS FOR THE 57 YEAR OLD FEMALE PATIENT ADMITTED IN FOR HEART VALVE SURGERY. THE PATIENT WAS KNOWN TO PRESENT IN SCAI STAGE E SHOCK AT PUMP IMPLANT. THE PUMP WAS PLACED ELECTIVELY FOR THE SURGERY. THE MEDICAL HISTORY WAS INCLUSIVE OF RIGHT LUNG HEMOTHORAX, BUT OTHER MEDICAL HISTORY WAS NOT SHARED. TWO DAYS AFTER IMPLANT THE PATIENT RETURNED TO THE OPERATING SUITE FOR CONCERNS OF POTENTIAL BLEEDING. IN THE OPERATION THE TEAM DISCOVERED A NEED TO EXTRACT THROMBUS. THE EXACT LOCATION OF THE THROMBOSIS WAS NOT SHARED. PATIENT WAS GIVEN BLOOD PRODUCTS OF 2 UNITS FRESH FROZEN PLASMA, 2 UNITS RED CELLS, AND 2 UNITS OF PLATELETS. THE PUMP WAS IN GOOD POSITION AND REMAINED ON FOR SUPPORT DESPITE THE HARM FOR 3 DAYS. AFTER 3 DAYS THE PUMP WAS WEANED AND EXPLANTED. 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 AND DIRECT SURGICAL AORTIC ACCESS. THE PATIENT SURVIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72470 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026631300 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1