BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24924562 · Received April 20, 2026

    Report

    Report Number
    1220648-2026-06963
    Event Type
    Injury
    Date Received
    April 20, 2026
    Date of Event
    April 14, 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

    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.

    Additional Manufacturer Narrative · 0

    D4: CORRECTED UDI.

    Description of Event or Problem · 0

    AN IMPELLA CP WAS INSERTED VIA THE FEMORAL ARTERY TO SUPPORT THE 70 YEAR OLD FEMALE PATIENT WHO HAD BEEN ADMITTED IN WITH INDICATION OF ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK, PRESENTING IN SCAI STAGE E SHOCK AT PUMP PLACEMENT. THE SUPPORT WAS INITIATED IN THE COMMUNITY HOSPITAL AND THEN THE PATIENT WAS TRANSFERRED TO THE TERTIARY CENTER FOR CARE ESCALATION. UNDERLYING MEDICAL HISTORY WAS NOT SHARED. THE CP WAS SUPPORTING FOR 1 DAY WHEN THE PUMP WAS EXPLANTED AND CARE WAS ESCALATED TO THE IMPELLA 5.5 VIA THE AXILLARY ARTERY GRAFT SITE. WHEN THE CP WAS EXPLANTED THE TEAM ATTEMPTED TO ACHIEVE HEMOSTASIS BY THE USE OF PERCLOSE DEVICES X2. THE FIRST PERCLOSE WAS DEPLOYED BUT THE 2ND PECLOSE FAILED. THE TEAM HAD VASCULAR SURGERY REMOVE THE MALFUNCTIONING/BROKEN PERCLOSE DEVICE. THEY WERE SUCCESSFUL AND VASCULAR WAS ABLE TO CLOSE THE ACCESS SITE. THE TEAM WAS AWARE THEY HAD NOT BEEN THE ONE TO PLACE THE CP PUMP AND ACHIEVE THE FEMORAL ACCESS, SO THEY WERE PREPARED FOR ANY VASCULAR COMPLICATION. THEY HAD A FEMSTOP READY, AND THE VASCULAR TEAM. ABIOMED DOES NOT MANUFACTURE THE PERCLOSE DEVICE THAT FAILED TO ACHIEVE HEMOSTASIS AT THE PUMP INSERTION SITE AND LEAD TO THIS ACCESS SITE COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496904 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027832895 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1