BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24800038 · Received April 7, 2026

    Report

    Report Number
    1220648-2026-06471
    Event Type
    Injury
    Date Received
    April 7, 2026
    Date of Event
    March 30, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    PYX
    UDI-DI
    00813502012811
    PMA / PMN Number
    P170011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REVIEW, IT WAS IDENTIFIED THAT THE MANUFACTURER FAX (D3) WAS INADVERTENTLY OMITTED IN ERROR; THE COMPLETE FAX NUMBER HAS NOW BEEN PROVIDED. CORRECTED INFORMATION HAS BEEN PROVIDED IN D4 SERIAL NUMBER. CORRECTED INFORMATION HAS BEEN PROVIDED IN D4 CATALOG NUMBER. H6 INVESTIGATION: TYPE, FINDINGS, AND CONCLUSION CODES AND H6 COMPONENT CODES WERE UPDATED ACCORDINGLY BASED ON THE COMPLETED INVESTIGATION. THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    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.

    Description of Event or Problem · 0

    AN IMPELLA RP FLEX DEVICE WAS INSERTED SURGICALLY INTO THE RIGHT FEMORAL VEIN IN A 67-YEAR-OLD MALE PATIENT WITH A PAST MEDICAL HISTORY OF CORONARY ARTERY DISEASE (CAD), PRESENTING IN POST-CARDIOTOMY CARDIOGENIC SHOCK (PCCS) AND LOW CARDIAC OUTPUT SYNDROME (LCOS), IN SCAI STAGE D SHOCK, ON MULTIPLE INOTROPES AND VASOPRESSORS, AND ON A VENTILATOR FOR RESPIRATORY SUPPORT, PRIOR TO INITIATION OF SUPPORT. THE IMPELLA WAS INSERTED FOR VENTRICULAR SUPPORT POST-OPERATIVELY CARDIOTHORACIC (CT) SURGERY: CABG AND AORTIC AND MITRAL VALVE REPAIR/REPLACEMENT. THE IMPELLA WAS PLACED DUE TO RIGHT VENTRICLE (RV) DYSFUNCTION/FAILURE. WHILE THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU), THE PATIENT WAS NOTED TO HAVE POST-OPERATIVE BLEEDING REQUIRING MULTIPLE PACKED RED BLOOD CELLS (PRBCS), FRESH FROZEN PLASMA (FFP), AND PLATELET TRANSFUSIONS. THE FOLLOWING DAY, THE IMPELLA WAS REMOVED. THE POST-PROCEDURE OUTCOME IS SURVIVED AT EXPLANT. THE IMPELLA FUNCTIONED AT P-5 AT 2.2L/MIN AS INTENDED. BLEEDING IS A KNOWN RISK DUE TO THE IMPELLA'S ANTICOAGULATION AND PURGE REQUIREMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45286 IMPELLA TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP PYX ABIOMED, INC. - 1220648 2026622775 00813502012811

    Patients

    Seq Age Sex Outcome Treatment
    1