BEUDAMED
    FDA Adverse Event Death Summary report: N

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

    MDR report key: 25110903 · Received May 7, 2026

    Report

    Report Number
    1220648-2026-07616
    Event Type
    Death
    Date Received
    May 7, 2026
    Date of Event
    May 1, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    DYB
    UDI-DI
    00813502011678
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B5 UPDATED WITH ADDITIONAL INFORMATION. D1 REVISED.

    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

    H6: UPDATED CODES BASED ON THE RESULTS OF THE INVESTIGATION. H11: UPDATED BASED ON THE RESULTS OF THE INVESTIGATION AND ADDED CLINICAL REVIEW. CORRECTED INFORMATION HAS BEEN PROVIDED IN D3( MANUFACTURER FAX). UPON REVIEW, IT WAS IDENTIFIED THAT THE INFORMATION WAS INADVERTENTLY NOT SUBMITTED IN THE INITIAL REPORT. THE ROOT CAUSE OF THE INJURY WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Description of Event or Problem · 0

    PEEL AWAY WAS LEFT IN. PULSES WERE NOT OBTAINED PRIOR TO INSERTION OF THE SHEATH. DEVICE WAS DISPOSED OF.

    Description of Event or Problem · 0

    CLINICAL NARRATIVE: AN IMPELLA CP DEVICE WAS INSERTED INTO THE RIGHT FEMORAL ARTERY IN A 78-YEAR-OLD FEMALE PATIENT PRESENTING IN ACUTE MYOCARDIAL INFARCTION (AMI) AND CARDIOGENIC SHOCK (CGS), IN SCAI STAGE E SHOCK, ON MULTIPLE INOTROPES AND VASOPRESSORS, PRIOR TO INITIATION OF SUPPORT. WHILE THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU), NO DISTAL PULSES WERE NOTED. AFTER ONE DAY ON SUPPORT, THE FAMILY WITHDREW CARE, AND THE PATIENT EXPIRED. THE IMPELLA FUNCTIONED AT P-5 AT 2.7 L/MIN AS INTENDED. LIMB ISCHEMIA CAN BE INFLUENCED BY PATIENT-SPECIFIC FACTORS SUCH AS PERIPHERAL VASCULAR DISEASE, UNDERLYING CRITICAL ILLNESS, HEMODYNAMIC INSTABILITY, ANTICOAGULATION STATUS, VASOPRESSOR SUPPORT, AND VASCULAR ACCESS CHARACTERISTICS. THE IMPELLA IS BEING CONSERVATIVELY REPORTED FOR DEATH; HOWEVER, IS UNLIKELY TO HAVE CONTRIBUTED TO THE PATIENT'S DEATH, WHICH WAS MOST LIKELY DUE TO THE CLINICAL CONDITION OF A CRITICALLY ILL PATIENT WITH ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK, COMPLICATED BY STAGE E SHOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208596 KIT, 14FR INTRODUCER, 13CM&25CM, AMB INTRODUCER, CATHETER (INTRODUCER) DYB ABIOMED, INC. - 1220648 00813502011678

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Death