BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 25183337 · Received May 15, 2026

    Report

    Report Number
    1220648-2026-07888
    Event Type
    Injury
    Date Received
    May 15, 2026
    Date of Event
    May 8, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A4 WEIGHT 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.

    Description of Event or Problem · 0

    CLINICAL NARRATIVE: IMPELLA CP WAS INSERTED VIA THE RIGHT FEMORAL ARTERY IN A 67-YEAR-OLD MALE FOR THE INDICATION OF ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK. THE PATIENT WAS IN SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY AND INTERVENTIONS SHOCK STAGE D AND WAS INITIALLY MANAGED AND TRANSFERRED TO THE INTENSIVE CARE UNIT. DURING THE INTENSIVE CARE UNIT STAY, THE PATIENT DEVELOPED A HEMATOMA AT THE ACCESS SITE AROUND THE REPOSITIONING SHEATH OVERNIGHT, WHICH REQUIRED TRANSFUSION OF BLOOD PRODUCTS OF 5 UNITS. HEMOSTASIS WAS ACHIEVED BY USING A FEMOSTOP DEVICE. PULSES WERE ASSESSED AND CONFIRMED BY DOPPLER, WITH NO EVIDENCE OF LOWER EXTREMITY ISCHEMIA OR COMPROMISED BLOOD FLOW. ADDITIONAL CONTRIBUTING FACTORS TO THE HEMATOMA DEVELOPMENT INCLUDED INTERMITTENT PATIENT MOVEMENT AND UNDERLYING OBESITY. PT REMAINED ON SUPPORT FOR 4 DAYS AND SUCCESSFULLY WEAN AND SURVIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138776 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026810848 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1