BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 24840702 · Received April 10, 2026

    Report

    Report Number
    1220648-2026-06655
    Event Type
    Death
    Date Received
    April 10, 2026
    Date of Event
    April 3, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    DYB
    UDI-DI
    00813502013474
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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.

    Additional Manufacturer Narrative · 0

    MAJOR BLEED/ASAE: THE CAUSE OF THE ACCESS SITE ADVERSE EVENT WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Description of Event or Problem · 0

    CLINICAL NARRATIVE: AN IMPELLA CP WAS INSERTED VIA THE 14FR INTRODUCER PLACED AT THE FEMORAL ARTERY TO SUPPORT THE 85 YEAR OLD FEMALE PATIENT WHO HAD BEEN ADMITTED IN WITH ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK, PRESENTING IN SCAI STAGE D SHOCK. THE PATIENT WAS ALSO SUPPORTED BY INOTROPES, VASOPRESSORS, AND A VENT FOR RESPIRATORY NEEDS. THE UNDERLYING MEDICAL HISTORY WAS NOT SHARED. AFTER GAINING ACCESS AT THE GROIN THE TEAM OBSERVED A BLEED AFTER THE 14FR INTRODUCER WAS PLACED. THEY HAD USED BEST PRACTICES AND GAINED ACCESS WITH ULTRASOUND AND A MICRO-PUNCTURE KIT. THERE WAS VASCULAR DAMAGE AND WITHIN 4 HOURS THE PATIENT EXPIRED. THE REPORTED BLEED IS CONSISTENT WITH ACCESS-SITE COMPLICATIONS. IT IS NOT KNOWN WHAT SURGICAL INTERVENTION WAS DONE TO TREAT THE VESSEL DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    901010 IMPELLA INTRODUCER, CATHETER (INTRODUCER) DYB ABIOMED, INC. - 1220648 S10020647 00813502013474

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Female Death