BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA 5.5

    MDR report key: 23063508 · Received September 16, 2025

    Report

    Report Number
    1220648-2025-46518
    Event Type
    Injury
    Date Received
    September 16, 2025
    Date of Event
    June 13, 2023
    Report Date
    November 6, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A.4 IS UNKNOWN. THE IMPELLA DEVICE WAS DISCARDED BY THE CUSTOMER AND THEREFORE, AN EVALUATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED. LITERATURE CITATION: FRENKEL, M., FAJARDO, R., DOLLERSCHELL, J., BABER, A., HERMSEN, J., & XIA, Y. (2025). ECPELLA BRIDGE TO HEART TRANSPLANTATION FOR A LARGE ISCHEMIC VENTRICULAR SEPTAL DEFECT AND REFRACTORY VENTRICULAR ARRHYTHMIAS. JHLT OPEN, 9, 100288. HTTPS://DOI.ORG/10.1016/J.JHLTO.2025.100288.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF THE REPORTED FAILURE MODES HAS BEEN COMPLETED. THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. ARRYTHMIA/TACHYCARDIA: THE ROOT CAUSE OF THE INJURY WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. LOW PUMP FLOW: DATA LOG REVIEW SHOWED NO MOTOR CURRENT SPIKES. THE FLOW LEVELS ARE ON THE LOWER END OF SPECIFICATION OR SLIGHTLY BELOW. THE CAUSE OF THE LOW PUMP FLOW WAS MOST LIKELY PATIENT RELATED, WHICH IS CONFIRMED BY THE LOW PULSATILITY SEEN IN THE DATA LOGS. DEVICE HISTORY REVIEW: THE DEVICE PASSED ALL THE POST STERILE INSPECTION CHECKS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WITH ISCHEMIC VENTRICULAR SEPTAL DEFECT (VSD) HAD AN IMPELLA 5.5 IMPLANTED DUE TO ONGOING PULMONARY CONGESTION AND TO ALLOW FOR REHABILITATION PRIOR TO VSD REPAIR. PER THE PUBLICATION, THE IMPELLA 5.5 HAD LOWER THAN EXPECTED FLOWS DESPITE OPTIMAL POSITIONING DUE TO SMALL LEFT VENTRICLE CAVITY (CONTEXT: ELEVATED RIGHT-SIDED FILLING PRESSURES) AS WELL AS EPISODES OF INCREASING ECTOPY THAT DEGENERATED INTO AN EPISODE OF UNSTABLE VENTRICULAR TACHYCARDIA LOCALIZED TO THE SAME REGION AS THE VSD. THE IMPELLA 5.5 WAS ESCALATED TO VENO-ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION AND THE PATIENT SURVIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2668553 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.5 2024309067 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Other