BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 25183758 · Received May 15, 2026

    Report

    Report Number
    1220648-2026-07895
    Event Type
    Injury
    Date Received
    May 15, 2026
    Date of Event
    May 10, 2026
    Report Date
    May 15, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 DEVICE WAS PLACED VIA A LEFT SURGICAL ARTERIAL APPROACH IN A 50-YEAR-OLD MALE PATIENT ADMITTED FOR CARDIOMYOPATHY, PRESENTING IN SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY AND INTERVENTIONS (SCAI) STAGE E CARDIOGENIC SHOCK. PRIOR TO PLACEMENT OF THE IMPELLA RP AND IMPELLA 5.5, THE PATIENT HAD RECEIVED HEMODYNAMIC SUPPORT WITH AN INTRA-AORTIC BALLOON PUMP (IABP) AND EXTRA-CORPOREAL MEMBRANE OXYGENATION (ECMO). ADDITIONAL UNDERLYING MEDICAL HISTORY WAS NOT SHARED. THE PATIENT WAS PLACED ON AN IMPELLA RP FLEX AND AN IMPELLA 5.5 TO PROVIDE BIVENTRICULAR MECHANICAL CIRCULATORY SUPPORT. DURING SUPPORT, PLASMA-FREE HEMOGLOBIN WAS REPORTED TO BE SIGNIFICANTLY ELEVATED, RAISING CONCERN FOR HEMOLYSIS, WHICH WAS PRESUMED TO BE ASSOCIATED WITH IMPELLA RP FLEX SUPPORT BASED ON THE AVAILABLE INFORMATION. IN RESPONSE TO ONGOING CLINICAL INSTABILITY, BOTH THE IMPELLA RP FLEX AND IMPELLA 5.5 WERE REMOVED, AND THE PATIENT WAS RE-CANNULATED FOR VENO-ARTERIAL ECMO (VA-ECMO) SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329550 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027826459 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1