BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 23935477 · Received December 31, 2025

    Report

    Report Number
    1220648-2025-49638
    Event Type
    Death
    Date Received
    December 31, 2025
    Date of Event
    December 9, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012279
    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

    THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER; THEREFORE, INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Additional Manufacturer Narrative · 0

    CLINICAL ASSESSMENT WAS COMPLETED AND DOCUMENTED TO B5 (EVENT DESCRIPTION). ADDITIONALLY, COMPLAINT CODING WAS UPDATED AND AS A RESULT, H6 HEALTH EFFECT - CLINICA/IMPACT CODING AND MEDICAL DEVICE PROBLEM CODING HAVE BEEN RECAPTURED, FULLY POPULATED. D1 BRAND NAME, D4 CATALOG NUMBER AND D4 SERIAL NUMBER WERE UPDATED, CORRECTED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    COMPLAINT CODING WAS REVISITED AND UPDATED TO MORE ACCURATELY REFLECT THE REPORTED EVENT. AS A RESULT, THE H6 HEALTH EFFECT ¿ CLINICAL/IMPACT AND MEDICAL DEVICE PROBLEM CODING HAS BEEN FULLY UPDATED AND SHOULD BE CONSIDERED THE REPRESENTATION OF THE REPORTED EVENT. THE INVESTIGATION IS IN PROGRESS. 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

    PER (B)(4). THERE WERE NO NOTED CLINICAL OR DEVICE ADVERSE EVENTS ASSOCIATED WITH THIS COMPLAINT. THE PATIENT EXPIRED WHILE ON SUPPORT MOST LIKELY DUE TO THE PATIENTS UNDERLYING CRITICAL PRESENTATION. HOWEVER, CONSERVATIVELY, THE DEATH WILL BE REPORTED. NO PRODUCT WAS RETURNED FOR INVESTIGATION AND THEREFORE THERE ARE NO DEVICE FINDINGS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT CODED IN THE INTENSIVE CAR UNIT AND BROUGHT TO THE CATH LAB. PHYSICIAN DECIDED TO PUT IN IMPELLA CP TO SUPPORT THE PATIENT. THE PATIENT EXPIRED IN THE CATH LAB, NOT DUE TO IMPELLA RELATED ISSUES. NO FURTHER INFORMATION WAS REPORTED.

    Description of Event or Problem · 0

    A 48-YEAR-OLD FEMALE WHO PRESENTED WITH AMI/CGS. THERE WERE NO NOTED CLINICAL OR DEVICE ADVERSE EVENTS ASSOCIATED WITH THIS COMPLAINT. THE PATIENT EXPIRED WHILE ON SUPPORT MOST LIKELY DUE TO THE PATIENTS UNDERLYING CRITICAL PRESENTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204579 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2026765855 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1