BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24544086 · Received March 9, 2026

    Report

    Report Number
    1220648-2026-04724
    Event Type
    Injury
    Date Received
    March 9, 2026
    Date of Event
    February 26, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502011401
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A4 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.

    Additional Manufacturer Narrative · 0

    A4 PATIENT HEIGHT WAS ADDED.

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS RETURNED, AND AN EVALUATION IS UNDERWAY. UPON COMPLETION OF OUR ANALYSIS, A SUPPLEMENTAL REPORT WILL BE FILED. SECTION D9 HAS BEEN UPDATED.

    Additional Manufacturer Narrative · 0

    B1 PRODUCT PROBLEM WAS INCORRECTLY SELECTED IN INITIAL REPORT.

    Description of Event or Problem · 0

    AN IMPELLA 5.5 DEVICE WAS INSERTED INTO THE RIGHT AXILLARY/SUBCLAVIAN ARTERY IN A 66-YEAR-OLD MALE PATIENT WITH A PAST MEDICAL HISTORY OF A PRIOR CORONARY ARTERY BYPASS GRAFT (CABG), AND CORONARY ARTERY DISEASE (CAD), PRESENTING IN ACUTE MYOCARDIAL INFARCTION (AMI) AND CARDIOGENIC SHOCK (CGS), IN AN OUT-OF-HOSPITAL CARDIAC ARREST REQUIRING CARDIOPULMONARY RESUSCITATION (CPR), IN SCAI STAGE D SHOCK, ON MULTIPLE INOTROPES AND VASOPRESSORS, AND ON A VENTILATOR FOR RESPIRATORY SUPPORT, PRIOR TO INITIATION OF SUPPORT. THE IMPELLA 5.5 WAS INSERTED AS AN ESCALATION OF THERAPY FROM AN IMPELLA CP. WHILE THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU), THE PHYSICIAN WAS CONCERNED FOR HEMOLYSIS. THE LACTATE DEHYDROGENASE (LDH) WAS 800. THE PATIENT WAS ON CONTINUOUS RENAL REPLACEMENT (CRRT). THE FOLLOWING DAY, THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR A TRANSPLANT WORKUP. UPON ARRIVAL, THE STAFF ATTEMPTED TO PERFORM AN AUTOMATED IMPELLA CONTROLLER (AIC) TO AIC TRANSFER. THE PURGE DISC WAS NOT RECOGNIZABLE. THE FACILITY DECIDED TO KEEP THE AIC FROM THE OUTSIDE HOSPITAL. THE POST-PROCEDURE OUTCOME IS UNKNOWN. THE IMPELLA FUNCTIONED AT P-6 AT 4.5L/MIN AS INTENDED. HEMOLYSIS MAY BE INFLUENCED BY PATIENT-SPECIFIC FACTORS SUCH AS CRITICAL ILLNESS, UNDERLYING CARDIAC DYSFUNCTION, HEMODYNAMIC INSTABILITY, AND POTENTIAL DEVICE POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603336 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 1849119 00813502011401

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention