BEUDAMED
    FDA Adverse Event Death Summary report: N

    KIT, 14FR INTRODUCER, 13CM&25CM, STERILE

    MDR report key: 25145764 · Received May 12, 2026

    Report

    Report Number
    1220648-2026-07739
    Event Type
    Death
    Date Received
    May 12, 2026
    Date of Event
    May 4, 2026
    Report Date
    May 11, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    DYB
    UDI-DI
    00813502013474
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 DEVICE WAS INSERTED VIA THE LEFT FEMORAL ARTERY IN A 79-YEAR-OLD FEMALE PATIENT PRESENTING WITH ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK (AMI/CGS). PATIENT'S COMORBIDITIES WERE UNKNOWN. THE PATIENT¿S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS IDENTIFIED AS SCAI SHOCK STAGE D. DURING PEEL AWAY EXCHANGE, THE WING BROKE OFF FROM THE SHEATH. THE TEAM USED A KELLY CLAMP TO GRIP THE SHEATH AND COMPLETE REMOVAL. CARE WAS SUBSEQUENTLY WITHDRAWN, AND THE PATIENT EXPIRED. THE DEVICE WILL BE CONSERVATIVELY REPORTED FOR DEATH; HOWEVER, THE DEATH IS MOST LIKELY ATTRIBUTED TO THE PATIENT¿S UNDERLYING CRITICAL CLINICAL CONDITION AS THEY PRESENTED IN SCAI SHOCK STAGE D.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66201 KIT, 14FR INTRODUCER, 13CM&25CM, STERILE INTRODUCER, CATHETER (INTRODUCER) DYB ABIOMED, INC. - 1220648 S9913598 00813502013474

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Death| R