BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 25123755 · Received May 8, 2026

    Report

    Report Number
    1220648-2026-07677
    Event Type
    Injury
    Date Received
    May 8, 2026
    Date of Event
    May 4, 2026
    Report Date
    May 8, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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

    CLINICAL NARRATIVE: AN IMPELLA 5.5 WAS ATTEMPTED VIA A LEFT SURGICAL AXILLARY APPROACH IN A 62-YEAR-OLD FEMALE PATIENT FOR THE INDICATION OF CARDIOMYOPATHY, PRESENTING IN SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY AND INTERVENTIONS (SCAI) STAGE D SHOCK. DURING THE PROCEDURE, A GUIDEWIRE WAS SUCCESSFULLY ADVANCED INTO THE LEFT VENTRICLE; HOWEVER, THE IMPELLA 5.5 DEVICE COULD NOT BE ADVANCED INTO THE AORTA. ADVANCED TROUBLESHOOTING MEASURES WERE PERFORMED, INCLUDING USE OF A BUDDY WIRE, VIPERSLIDE, AND A NEW 0.018-INCH GUIDEWIRE, WITHOUT SUCCESS. AN ANGIOGRAM WAS OBTAINED, WHICH IDENTIFIED VASCULAR STENOSIS, LIMITING DEVICE ADVANCEMENT. BASED ON THESE FINDINGS, THE DECISION WAS MADE TO ABORT THE IMPELLA 5.5 PLACEMENT, AND AN IMPELLA CP DEVICE WAS IMPLANTED INSTEAD. THE INABILITY TO ADVANCE THE IMPELLA 5.5 IS CONSISTENT WITH PATIENT-SPECIFIC VASCULAR ANATOMY AND ACCESS LIMITATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310389 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026812477 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1