BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24626594 · Received March 18, 2026

    Report

    Report Number
    1220648-2026-05543
    Event Type
    Injury
    Date Received
    March 18, 2026
    Date of Event
    March 26, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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. CORRECTED INFORMATION HAS BEEN PROVIDED IN D1. THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Additional Manufacturer Narrative · 0

    LITERATURE CITATION: AN, K., ELMOUSLY, A., LEE, J., MITCHELL, D., FRIED, J., YUNIS, A., MASOUMI, A., YUZEFPOLSKAYA, M., COLOMBO, P., SAYER, G., URIEL, N., & TAKEDA, K. (2026). HIDDEN DANGER OF MICROAXIAL FLOW PUMPS: FIVE CASES OF AORTIC AND INNOMINATE MURAL THROMBI. THE JOURNAL OF HEART AND LUNG TRANSPLANTATION. HTTPS://DOI.ORG/10.1016/J.HEALUN.2026.02.1679 . 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 RATIONALE: AN IMPELLA 5.5 DEVICE WAS INSERTED SURGICALLY INTO THE RIGHT AXILLARY/SUBCLAVIAN ARTERY IN A 57-YEAR-OLD FEMALE PATIENT WITH A PAST MEDICAL HISTORY OF ASTHMA, HYPERLIPIDEMIA, HEART FAILURE WITH AN EJECTION FRACTION OF 55%, AND CARDIAC SARCOIDOSIS, PRESENTING IN HEART FAILURE/CARDIOGENIC SHOCK, CARDIOMYOPATHY, RECURRENT VENTRICULAR TACHYCARDIA, AND SEVERE TRICUSPID REGURGITATION, IN SCAI STAGE E SHOCK, ON AN INTRA-AORTIC BALLOON PUMP (IABP), ON MULTIPLE INOTROPES AND VASOPRESSORS, AND ON A VENTILATOR FOR RESPIRATORY SUPPORT, PRIOR TO INITIATION OF SUPPORT. EIGHT DAYS AFTER IMPELLA INSERTION, THE DEVICE WAS REMOVED WITH A BRIDGE TO A HEART TRANSPLANT. THE POST-PROCEDURE OUTCOME IS SURVIVED AT EXPLANT. THE IMPELLA FUNCTIONED AT P-4 AT 1.8L/MIN AS INTENDED. IT WAS LATER PUBLISHED IN A JOURNAL THAT AFTER THE IMPELLA PLACEMENT, A PERIPHERAL VENO-ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION (VA-ECMO) WAS PLACED FOR CARDIOGENIC SHOCK. SEVEN DAYS LATER, MURAL THROMBI WAS FOUND IN THE ASCENDING AORTA AT THE TIME OF THE TRANSPLANT. THE PATIENT HAD AN UNEVENTFUL RECOVERY AND WAS DISCHARGED FROM THE HOSPITAL 16 DAYS POST-TRANSPLANT. THROMBUS (THROMBOSIS) CAN OCCUR DUE TO INADEQUATE ANTICOAGULATION, AND IS AN ADVERSE EVENT ASSOCIATED WITH IMPELLA'S MECHANICAL SUPPORT. COMBINING IMPELLA WITH VA-ECMO (KNOWN AS ECPELLA) FOR CARDIOGENIC SHOCK TREATS SEVERE HEART FAILURE BY PROVIDING HEMODYNAMIC SUPPORT WHILE SIMULTANEOUSLY UNLOADING THE LEFT VENTRICLE (LV). THE COMBINED APPROACH RESULTS IN BETTER OVERALL HEART RECOVERY AND BETTER CLINICAL OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693056 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026624610 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Required Intervention