BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA 5.5 WITH SMARTASSIST S2 SET, US

    MDR report key: 24559693 · Received March 10, 2026

    Report

    Report Number
    1220648-2026-04904
    Event Type
    Injury
    Date Received
    March 10, 2026
    Date of Event
    October 22, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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

    61 YEAR OLD MALE WITH HISTORY OF CAD, ICM, HTN, AFIB PRESENTED WITH ACUTE ON CHRONIC DECOMPENSATED HF. (B)(6) UNDERWENT IMPELLA 5.5 IMPLANT VIA AXILLARY ARTERY AS A BRIDGE TO LVAD. (B)(6) LOSS OF OPTICAL SIGNAL WITH STABLE DEVICE FUNCTION AND PATIENT WELL SUPPORTED. (B)(6) NOTED TO HAVE MELENA WITH DROP IN HEMOGLOBIN REQUIRING TRANSFUSION. (B)(6) LVAD WITH EXPLANT OF IMPELLA 5.5 WITHOUT INCIDENT. DURING IMPELLA 5.5 SUPPORT, LOSS OF PLACEMENT SIGNAL WAS OBSERVED. PATIENT SUPPORT CONTINUED UNTIL THE PATIENT RECEIVED A DURABLE LVAD. THERE WERE NO ADVERSE EVENTS RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621309 IMPELLA 5.5 WITH SMARTASSIST S2 SET, US TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026732576 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention