BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA 5.5

    MDR report key: 24777040 · Received April 3, 2026

    Report

    Report Number
    1220648-2026-06357
    Event Type
    Injury
    Date Received
    April 3, 2026
    Date of Event
    March 28, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP MDR IS BEING SUBMITTED TO DOCUMENT ADDITIONAL INFORMATION RECEIVED FROM THE SALES REPRESENTATIVE CONFIRMING THAT THERE IS NO DEVICE AVAILABLE FOR RETURN. THIS INFORMATION IS CONSISTENT WITH THE INITIAL MDR, WHICH REPORTED THAT THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER.

    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 ROOT CAUSE OF THE INJURY WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Description of Event or Problem · 0

    AN IMPELLA 5.5 DEVICE WAS INSERTED SURGICALLY INTO THE RIGHT AXILLARY/SUBCLAVIAN ARTERY IN A 62-YEAR-OLD MALE PATIENT WITH A PAST MEDICAL HISTORY OF CORONARY ARTERY DISEASE (CAD) AND DIABETES, PRESENTING IN HEART FAILURE, CARDIOGENIC SHOCK, CARDIOMYOPATHY, IN SCAI STAGE D SHOCK, ON MULTIPLE INOTROPES AND VASOPRESSORS, AND ON A VENTILATOR FOR RESPIRATORY SUPPORT, PRIOR TO INITIATION OF SUPPORT. WHILE THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU), THE PATIENT DEVELOPED ATRIAL FIBRILLATION. AMIODARONE WAS STARTED AND ALBUMIN GIVEN, AND THE PATIENT RETURNED TO NORMAL SINUS RHYTHM. AN ECHOCARDIOGRAM CONFIRMED GOOD POSITION. THREE DAYS AFTER IMPELLA INSERTION, THE DEVICE WAS SUCCESSFULLY WEANED. THE IMPELLA FUNCTIONED AT P-4 AT 2.7L/MIN AS INTENDED. ARRYTHMIAS MAY BE INFLUENCED BY PATIENT-SPECIFIC FACTORS SUCH AS CRITICAL ILLNESS, UNDERLYING CARDIAC DYSFUNCTION, HEMODYNAMIC INSTABILITY, AND IMPROPER DEVICE POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187983 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026802637 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1