BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 25110297 · Received May 7, 2026

    Report

    Report Number
    1220648-2026-07604
    Event Type
    Injury
    Date Received
    May 7, 2026
    Date of Event
    April 30, 2026
    Report Date
    May 12, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B5 UPDATED. F1905 ADDED TO H6. THE INVESTIGATION IS STILL ONGOING.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED. MEDICAL INTERVENTION WAS NOT REQUIRED BECAUSE THE PATIENT WAS TAKEN DOWN SHORTLY AFTER AND THE IMPELLA CP PUMP WAS EXCHANGED OUT FOR AN IMPELLA 5.5. THE PATIENT HAS NOT EXPERIENCE HEMOLYSIS SINCE. 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. INTERVENTION DONE WAS: PUMP ESCALATION FROM A CP TO A 5.5.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION HAS BEEN PROVIDED: "THE PUMP WAS DISCARDED AND IS NOT AVAILABLE FOR RETURN. THE TEAM ESCALATED SUPPORT TO AN IMPELLA 5.5, AFTER WHICH THE HEMOLYSIS FULLY RESOLVED. THERE WERE NO FURTHER SIGNS OF HEMOLYSIS FOLLOWING THE DEVICE EXCHANGE."

    Description of Event or Problem · 0

    CLINICAL NARRATIVE: AN IMPELLA CP WAS INSERTED VIA THE RIGHT FEMORAL ARTERY IN A 76-YEAR-OLD MALE PATIENT PRESENTING IN SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY AND INTERVENTIONS (SCAI) STAGE D CARDIOGENIC SHOCK. DURING IMPELLA CP SUPPORT, THE PATIENT'S URINE WAS NOTED TO BE RED-TINGED, RAISING CONCERN FOR HEMOLYSIS. LABORATORY TESTING DEMONSTRATED A PLASMA-FREE HEMOGLOBIN (PFHGB) LEVEL OF 50 MG/DL. AN ECHOCARDIOGRAM WAS OBTAINED, WHICH CONFIRMED THE IMPELLA CP WAS POSITIONED AT 3.5 CM. THE PATIENT REQUIRED ESCALATION OF THERAPY. FOLLOWING ESCALATION, HEMOLYSIS RESOLVED, WITH URINE COLOR RETURNING TO YELLOW AND URINE OUTPUT INCREASING TO APPROXIMATELY 30 CC/HR. THE PATIENT SURVIVED TO IMPELLA CP EXPLANT AND SUBSEQUENTLY UNDERWENT ESCALATION OF THERAPY TO AN IMPELLA 5.5. HEMOLYSIS IS A KNOWN POTENTIAL RISK ASSOCIATED WITH IMPELLA SUPPORT AND MAY BE INFLUENCED BY PATIENT-SPECIFIC FACTORS, UNDERLYING CARDIOGENIC SHOCK, AND HEMODYNAMIC CONDITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208574 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027869930 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1