BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 25137053 · Received May 11, 2026

    Report

    Report Number
    1220648-2026-07731
    Event Type
    Injury
    Date Received
    May 11, 2026
    Date of Event
    May 1, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: UPDATED CODES BASED ON THE RESULTS OF THE INVESTIGATION. H11: UPDATED BASED ON THE RESULTS OF THE INVESTIGATION AND ADDED CLINICAL REVIEW. THE CAUSE OF HEMOLYSIS/PATIENT-DEVICE INTERACTION WAS UNABLE TO BE DETERMINED AS LIMITED CLINICAL DETAILS WERE PROVIDED AND NO PRODUCT WAS RETURNED FOR REVIEW.

    Additional Manufacturer Narrative · 0

    A5 IS 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 CP WAS INSERTED VIA THE RIGHT FEMORAL ARTERY TO SUPPORT THE 75-YEAR-OLD MALE ADMITTED IN WITH INDICATION OF ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK, PRESENTING IN SCAI STAGE E SHOCK. THE UNDERLYING MEDICAL HISTORY WAS NOT SHARED. ON THE DAY OF PUMP IMPLANT THERE WAS OBSERVED SIGNS OF HEMOLYSIS. THE TEAM ATTEMPTED TO TROUBLESHOOT BY REPOSITIONING THE PUMP WITHIN THE LEFT VENTRICLE, BUT THIS DID NOT RESOLVE THE HEMOLYSIS. THE URINE COLOR REMAINED RED TINGED. ON THE SECOND DAY OF SUPPORT THE ADDED VA-EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). WITH THE ADDITION OF ECMO AND PUMP POSITION OPTIMIZATION THE URINE COLOR BEGAN TO CLEAR. AFTER DAY 3 OF THE SUPPORT THE TEAM MADE THE DECISION TO ESCALATE CARE TO THE IMPELLA 5.5 PUMP. THE PATIENT REMAINS ON ECMO AND THE 5.5 PUMP., AND HAS SURVIVED TO DATE. THE HEMOLYSIS IS NOTED TO HAVE BEEN RESOLVED AND WAS NOT SOLELY CONTRIBUTED TO BE THE USE OF IMPELLA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52333 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026651663 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1