BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 25299658 · Received May 27, 2026

    Report

    Report Number
    1220648-2026-08182
    Event Type
    Injury
    Date Received
    May 27, 2026
    Date of Event
    May 18, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    AN IMPELLA CP WAS INSERTED VIA THE RIGHT FEMORAL ARTERY TO SUPPORT THE 50 YEAR OLD MALE PATIENT WHO HAD BEEN ADMITTED IN WITH INDICATION OF ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK. THE UNDERLYING MEDICAL HISTORY WAS NOT SHARED. THE PUMP SUPPORTED FOR OVER 4 DAYS AND WAS EXPLANTED. DURING THE SUPPORT THE PUMP PERFORMED IN THE EXPECTED RANGE WITH PUMP P-LEVEL 4 WITH FLOWS OF 2.5L/MIN. AFTER EXPLANT THE TEAM OBSERVED CLOT BURDEN. THE TEAM INTERVENED AND THE CLOT WAS SUCTIONED. ONCE THE THROMBUS WAS REMOVED THE FLOW WAS GOOD ON ANGIOGRAM AND THE PULSES WERE PALPABLE. NO FURTHER INTERVENTION WAS DEEMED NECESSARY. LIMB THROMBOSIS IS A KNOWN RISK WITH LARGE BORE ACCESS SHEATHS AND HAS AN INCREASED RISK OF OCCURRENCE IN PATIENTS IN SCAI SHOCK STAGE C,D, AND E SINCE THERE IS POTENTIAL FOR THE PATIENT TO CONCURRENTLY BE ON VASOPRESSORS AND INOTROPES FOR MEDICAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380639 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027870210 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1