BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA CPSA C9+ SET, OUS

    MDR report key: 25284476 · Received May 26, 2026

    Report

    Report Number
    1220648-2026-08168
    Event Type
    Injury
    Date Received
    May 26, 2026
    Date of Event
    May 21, 2026
    Report Date
    May 26, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502013344
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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

    AN IMPELLA CPSA C9 DEVICE WAS INSERTED INTO THE RIGHT FEMORAL ARTERY IN A PATIENT PRESENTING IN ACUTE MYOCARDIAL INFARCTION (AMI) AND CARDIOGENIC SHOCK (CGS), IN SCAI C SHOCK, AND ON MULTIPLE INOTROPES AND VASOPRESSORS, PRIOR TO INITIATION OF SUPPORT. THE PATIENT IDENTIFIERS ARE UNKNOWN. WHILE THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU), THERE WERE CONTINUOUS SUCTION ALARMS WITH NO IMPROVEMENT DESPITE CORRECT POSITIONING AND REDUCTION OF THE P-LEVEL. THE PUMP WAS WEANED AND REMOVED. UPON REMOVAL OF THE PUMP, TISSUE AND THROMBOTIC MATERIAL WERE NOTED IN THE PUMP CANNULA. THE PATIENT WAS HEMODYNAMICALLY STABLE. THE POST-PROCEDURE OUTCOME IS SURVIVED AT EXPLANT. WHILE ON SUPPORT, THE DEVICE FUNCTIONED AT P-8 AT 3.4L/MIN AS INTENDED WITH D5W SODIUM BICARBONATE IN THE PURGE SOLUTION. THROMBUS (THROMBOSIS) CAN OCCUR DUE TO INADEQUATE ANTICOAGULATION, AND IS AN ADVERSE EVENT ASSOCIATED WITH IMPELLA'S MECHANICAL SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105839 IMPELLA CPSA C9+ SET, OUS TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027875880 00813502013344

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention