BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24632110 · Received March 18, 2026

    Report

    Report Number
    1220648-2026-05518
    Event Type
    Injury
    Date Received
    March 18, 2026
    Date of Event
    March 9, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PPAE (AIR EMBOLISM): THE ROOT CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. ADDITIONAL INFORMATION HAS BEEN PROVIDED IN H6 (COMPONENT CODE, INVESTIGATION FINDINGS, TYPE OF INVESTIGATION, AND INVESTIGATION CONCLUSIONS).

    Additional Manufacturer Narrative · 0

    A4 IS UNKNOWN. 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

    D6B, DATE OF EXPLANT, HAS BEEN ADDED.

    Description of Event or Problem · 0

    A 44-YEAR-OLD MALE WITH ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK, CONSISTENT WITH SCAI SHOCK STAGE D, WAS SUPPORTED WITH IMPELLA THERAPY. DURING THE PROCEDURE, THE PATIENT EXPERIENCED CARDIAC ARREST AND THE IMPELLA CP (SN (B)(6)) WAS PLACED INTO SURGICAL MODE. THE DEVICE REMAINED IN SURGICAL MODE FOR APPROXIMATELY 20 MINUTES, WITH PUMP SUPPORT OFF AND ONLY THE PURGE SYSTEM OPERATING. THE PATIENT WAS ON BYPASS WITH HR 0, MAP 61, CVP 2, AND PAP 9. THE PHYSICIAN REPORTED OBSERVING ¿FOAMY BUBBLES¿ WHILE WORKING ON THE MITRAL VALVE AND REQUESTED CONFIRMATION THAT THE PUMP WAS OFF; DEVICE PARAMETERS CONFIRMED THAT THE PUMP WAS OFF AND REMAINED IN SURGICAL MODE AS EXPECTED. BASED ON THE INFORMATION AVAILABLE, THE IMPELLA CP OPERATED AS INTENDED WHILE IN SURGICAL MODE, WITH NO DEVICE MALFUNCTION IDENTIFIED AT THE TIME OF THE EVENT. THE VISUAL OBSERVATION OF ¿FOAMY BUBBLES¿ OCCURRED WHILE THE PUMP WAS CONFIRMED TO BE OFF AND PROVIDING NO FORWARD FLOW, WITH ONLY PURGE FLOW ACTIVE. THE PATIENT SURVIVED THE INITIAL SUPPORT PERIOD, AND THE IMPELLA 5.5 REMAINS IN PLACE FOR ONGOING THERAPY. FURTHER EVALUATION WILL BE PERFORMED UPON RETURN OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694560 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027825143 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Male Required Intervention