BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24575555 · Received March 11, 2026

    Report

    Report Number
    1220648-2026-05109
    Event Type
    Injury
    Date Received
    March 11, 2026
    Date of Event
    November 25, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D1 (BRAND NAME) & D4 (SERIAL) HAS BEEN UPDATED. D10 (CONCOMITANT) HAS BEEN ADDED. PPAE(TACHYCARDIA): THE ROOT 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

    PATIENT WAS ADMITTED WITH RESPIRATORY SYMPTOMS. THE PATIENT WAS INITIALLY PLACED ON ECMO AND INOTROPES SECONDARY TO VIRAL CARDIOMYOPATHY. AN IMPELLA 5.5 WAS PLACED TO HELP WITH LEFT VENTRICULAR UNLOADING AND TO HELP TO WEAN OFF ECMO. THE PATIENT HAD MULTIPLE EPISODES OF VENTRICULAR TACHYCARDIA (VT) AND INITIAL PLAN WAS FOR ABLATION. ON (B)(6) 2025, THE PATIENT WAS IMPLANTED WITH A DURABLE VENTRICULAR ASSIST DEVICE WITH IMPELLA 5.5 EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595611 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026771215 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Male Required Intervention EXTRACORPOREAL MEMBRANE OXYGENATION