BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24729689 · Received March 30, 2026

    Report

    Report Number
    1220648-2026-06116
    Event Type
    Injury
    Date Received
    March 30, 2026
    Date of Event
    March 21, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    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

    AN IMPELLA CP WAS INSERTED VIA THE FEMORAL ARTERY TO SUPPORT THE 70YEAR OLD FEMALE PATIENT WHO HAD BEEN ADMITTED IN WITH INDICATION OF ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK, PRESENTING IN SCAI STAGE D SHOCK. THE PATIENT WAS ON INOTROPES/VASOPRESSORS AND OXYGEN FOR RESPIRATORY NEEDS. THE UNDERLYING MEDICAL HISTORY WAS NOT SHARED. THE PUMP WAS SUPPORTING WHEN ON DAY 3 OF THE SUPPORT THE PATIENT WAS INFUSED WITH 1 UNIT OF PLATELETS DUE TO CONCERNS OF THROMBOCYTOPENIA WITH A PLATELET COUNT OF 32 AND INFUSED WITH 1 UNIT OF RED BLOOD CELLS DUE TO HEMOGLOBIN OF 7.7G/DL. THE TEAM ALSO STOPPED THE HEPARIN. THE PUMP SUPPORTED FOR 4+ DAYS WHEN EXPLANTED AFTER A SUCCESSFUL WEAN. THE PATIENT SURVIVED. ANTICOAGULATION NECESSARY FOR THE PUMP PLACEMENT AND SUPPORT CAN CONTRIBUTE TO BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793014 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027822510 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention