BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA 5.5

    MDR report key: 23896590 · Received December 26, 2025

    Report

    Report Number
    1220648-2025-49289
    Event Type
    Injury
    Date Received
    December 26, 2025
    Date of Event
    September 23, 2025
    Report Date
    December 24, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO PRODUCT WAS RETURNED FOR INVESTIGATION. PERICARDIAL EFFUSION: THE CAUSE OF THE CLINICAL SYMPTOM WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. TACHYCARDIA: IN ORDER TO MAKE A ROOT CAUSE DETERMINATION, ALL OF THE CLINICAL DETAILS OUTLINED IN (B)(4) WOULD HAVE TO BE PROVIDED. THE ROOT CAUSE OF THE TACHYCARDIA WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. DEVICE HISTORY LOT: DEVICE LOT: 1964716. DEVICE HISTORY BATCH: SUBCOMPONENT LOT: N/A. DEVICE HISTORY REVIEW: DEVICE WITH SN: (B)(6) PASSED ALL POST STERILE INSPECTION CHECKS.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED A PATIENT WAS IMPLANTED WITH AN IMPELLA 5.5 FOR MECHANICAL CIRCULATORY SUPPORT. DURING WIRE MANIPULATION ACROSS THE AORTIC VALVE INTO THE LEFT VENTRICLE, THE PATIENT DEVELOPED POLYMORPHIC VENTRICULAR TACHYCARDIA (VT), LIKELY DUE TO WIRE CONTACT WITH THE CORONARY SINUS. THE PATIENT WAS SUCCESSFULLY DEFIBRILLATED TWICE. FOLLOWING DEFIBRILLATION, THE IMPELLA 5.5 WAS SUCCESSFULLY POSITIONED, RAMPED UP, AND FUNCTIONED AS INTENDED. VASOPRESSOR SUPPORT WAS SUBSEQUENTLY WEANED, AND THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT FOR CONTINUED MANAGEMENT. THE PATIENT LATER EXPERIENCED ANOTHER EPISODE OF VT, WHICH REQUIRED SYNCHRONIZED CARDIOVERSION AND WAS SUCCESSFULLY RESOLVED. A SMALL PERICARDIAL EFFUSION WAS LATER IDENTIFIED ON COMPUTED TOMOGRAPHY (CT), AND A PERICARDIAL WINDOW PROCEDURE WAS PERFORMED. THE PATIENT¿S CONDITION STABILIZED, AND THE IMPELLA 5.5 WAS SUBSEQUENTLY WEANED AND EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2210416 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.5 2026730011 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Male Required Intervention