BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA 5.5 WITH SMARTASSIST S2 SET, US

    MDR report key: 24548095 · Received March 9, 2026

    Report

    Report Number
    1220648-2026-04801
    Event Type
    Injury
    Date Received
    March 9, 2026
    Date of Event
    October 15, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED; THEREFORE, EVALUATION AND ANALYSIS COULD NOT BE PERFORMED. A DEVICE HISTORY RECORD REVIEW WAS CONDUCTED AND CONFIRMED THE PUMP PASSED ALL POST STERILE INSPECTION CHECKS. THE CAUSE OF THE REPORTED RENAL FAILURE COULD NOT BE DETERMINED DUE TO INSUFFICIENT CLINICAL INFORMATION. H6 INVESTIGATION TYPE, FINDINGS AND CONCLUSION HAVE BEEN UPDATED BASED ON THE COMPLETED INVESTIGATION.

    Description of Event or Problem · 0

    49 YEAR OLD MALE WITH HISTORY OF CAD S/P PCI, ICM, T2DM, CKD (ST4) PRESENTED WITH ACUTE ON CHRONIC DECOMPENSATED HF. ON (B)(6) UNDERWENT CABG/ AVR WITH IMPLANT OF IMPELLA 5.5 VIA DIRECT AORTIC APPROACH. ON (B)(6) ACUTE ON CHRONIC KIDNEY DISEASE REQUIRING DIALYSIS. IT WAS NOTED THAT ALTHOUGH BELIEVED TO BE UNRELATED TO IMPELLA, CREATNINE CONTINUED TO CLIMB DURING IMEPLLA SUPPORT AND THAT THE PATIENT WAS GOING TO REQUIRE DIALYSIS. URINE OUTPUT OF THE PATIENT WAS BELOW 30 ML'S. 10/16 DIALYSIS INITIATED. ON (B)(6) IMP5.5 WEANED AND EXPLANTED WITHOUT INCIDENT. ON AS RENAL CONDITION WORSENED DURING SUPPORT, IT WILL BE CONSERVATIVELY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449797 IMPELLA 5.5 WITH SMARTASSIST S2 SET, US TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026689296 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1