BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 25093789 · Received May 6, 2026

    Report

    Report Number
    1220648-2026-07571
    Event Type
    Injury
    Date Received
    May 6, 2026
    Date of Event
    April 29, 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
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPANY REPRESENTATIVE CONFIRMED THAT THE PATIENT HAD RENAL FAILURE BEFORE IMPELLA. THE COMPANY REPRESENTATIVE WILL TRY TO GET THE PUMP BACK AFTER EXPLANT. 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

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THIS REPORT WILL BE DEEMED UNREPORTABLE.

    Description of Event or Problem · 0

    CLINICAL NARRATIVE: AN IMPELLA 5.5 DEVICE WAS INSERTED SURGICALLY INTO THE RIGHT AXILLARY/SUBCLAVIAN ARTERY IN A 37-YEAR-OLD MALE PATIENT WITH A PAST MEDICAL HISTORY OF DIABETES AND DIALYSIS, PRESENTING IN HEART FAILURE, CARDIOGENIC SHOCK, CARDIOMYOPATHY, IN SCAI STAGE C SHOCK, ON MULTIPLE INOTROPES AND VASOPRESSORS, PRIOR TO INITIATION OF SUPPORT. WHILE THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU), THE PATIENT WAS RECEIVING DIALYSIS AND HAD A SUCTION EVENT AND AN EPISODE OF VENTRICULAR TACHYCARDIA (VT). THE IMPELLA WAS REPOSITIONED UNDER ECHOCARDIOGRAM. A SMALL BOLUS OF ALBUMIN WAS GIVEN. NO FURTHER ISSUES WERE NOTED. THE POST-PROCEDURE OUTCOME IS UNKNOWN. THE IMPELLA FUNCTIONED AT P-8 AT 4.5L/MIN AS INTENDED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE LOW FLOW ISSUE WAS RESOLVED THROUGH STANDARD TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575117 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027848891 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1