BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT, 23FR INTRODUCER, 11CM, STERILE

    MDR report key: 24626226 · Received March 18, 2026

    Report

    Report Number
    1220648-2026-05514
    Event Type
    Injury
    Date Received
    March 18, 2026
    Date of Event
    February 25, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    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

    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.

    Description of Event or Problem · 0

    AN IMPELLA RP FLEX DEVICE WAS INSERTED VIA THE RIGHT FEMORAL VEIN IN A 54-YEAR-OLD MALE PATIENT PRESENTING WITH ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK (AMI/CGS), SCAI SHOCK STAGE D, WITH A HISTORY OF PRIOR CORONARY ARTERY BYPASS GRAFTING, KNOWN CORONARY ARTERY DISEASE, AND DIABETES MELLITUS. THE PATIENT RECEIVED 1¿UNIT OF PACKED RED BLOOD CELLS FOR LOW HEMOGLOBIN, AND GROIN OOZING WAS NOTED. THE PATIENT SURVIVED TO EXPLANT. THE REPORTED MAJOR BLEED REQUIRING BLOOD TRANSFUSION IS CONSISTENT WITH ACCESS-SITE COMPLICATIONS AND THE ANTICOAGULATION/PURGE REQUIREMENTS ASSOCIATED WITH IMPELLA SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688025 KIT, 23FR INTRODUCER, 11CM, STERILE TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Required Intervention