BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA 5.5 WITH SMARTASSIST S2 SET, US

    MDR report key: 24582146 · Received March 12, 2026

    Report

    Report Number
    1220648-2026-05165
    Event Type
    Malfunction
    Date Received
    March 12, 2026
    Date of Event
    October 15, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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

    60 YEAR OLD MALE WITH HISTOYR OF NICM, CKD PRESENTED WITH ACUTE ON CHRONIC DECOMPENSATED HF. (B)(6) UNDERWENT IMPLANT OF IMP5.5 AS A BTLVAD. (B)(6) OPTICAL SENSOR READING LOWER THAN ARTERIAL LINE VALUES. NORMAL DEVICE FUNCTION AND PATIENT SUPPORTED WELL. (B)(6) PATIENT UNDERWENT LVAD IMPLANT WITH EXPLANT OF IMP5.5 WITHOUT INCIDENT." DURING IMPELLA 5.5 SUPPORT, LOW PLACEMENT SIGNAL WAS NOTED COMPARED TO ARTERIAL LINE REFERENCE PRESSURE. PATIENT SUPPORT CONTINUED WITHOUT ISSUE UNTIL THE PATIENT RECEIVED A DURABLE LVAD. THERE WERE NO ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643821 IMPELLA 5.5 WITH SMARTASSIST S2 SET, US TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026732585 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male