BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 24429565 · Received February 24, 2026

    Report

    Report Number
    1220648-2026-03903
    Event Type
    Death
    Date Received
    February 24, 2026
    Date of Event
    February 13, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6 INVESTIGATION: TYPE, FINDINGS, AND CONCLUSION CODES AND H6 COMPONENT CODES WERE UPDATED ACCORDINGLY BASED ON THE COMPLETED INVESTIGATION. THE CAUSE OF THE ACCESS SITE ADVERSE EVENT WAS USE RELATED AS THE BLEEDING RESOLVED AFTER ANGLE MATCHING.

    Additional Manufacturer Narrative · 0

    THE SUSPECT MEDICAL DEVICE WAS INADVERTENTLY MISIDENTIFIED IN THE INITIAL REPORT. ACCORDINGLY, THE RELEVANT FIELDS IN SECTION D (SUSPECT MEDICAL DEVICE), SECTION G (ALL MANUFACTURERS), AND SECTION H (DEVICE MANUFACTURERS ONLY) HAVE BEEN CORRECTED AND UPDATED TO ACCURATELY REFLECT THE IMPELLA CP DEVICE. NOTE: H1. THE TYPE OF REPORTABLE EVENT (DEATH) AND B1. ADVERSE EVENT AND B2. OUTCOMES ATTRIBUTED TO THE ADVERSE EVENT REMAIN UNCHANGED AS PREVIOUSLY REPORTED. CORRECTION. E1 INITIAL REPORTER'S TITLE WITH OCCUPATION WERE CORRECTED. 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

    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

    CLINICAL RATIONALE: AN 80 YEAR OLD MALE WITH A HISTORY OF ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK, CONSISTENT WITH SCAI SHOCK STAGE E, UNDERWENT PERCUTANEOUS IMPELLA SUPPORT VIA RIGHT AXILLARY/SUBCLAVIAN ARTERIAL ACCESS ON (B)(6) 2026 AT 5:32 PM. FOLLOWING SUCCESSFUL INSERTION AND TRANSFER TO THE ICU, BLEEDING WAS OBSERVED AT THE ACCESS SITE. THE ATTENDING PHYSICIAN EVALUATED THE PATIENT AT THE BEDSIDE, AND THE BLEEDING IMPROVED AFTER ANGLE MATCHING. THE ACTIVATED CLOTTING TIME (ACT) WAS 243 SECONDS AT THE TIME OF THE EVENT. BASED ON THE AVAILABLE INFORMATION, THE OBSERVED BLEEDING EVENTS APPEAR CONSISTENT WITH KNOWN PROCEDURAL RISKS OF LARGE BORE VASCULAR ACCESS IN CRITICALLY ILL PATIENTS AND DO NOT SUGGEST A DEVICE MALFUNCTION. CLINICAL FACTORS¿INCLUDING ANTICOAGULATION LEVELS, PATIENT MOVEMENT, OBESITY AND UNDERLYING CONDITION¿LIKELY CONTRIBUTED TO THE BLEEDING, AND THE IMPELLA DEVICES PERFORMED AS EXPECTED. AN ACCESS SITE BLEED IS A KNOWN RISK PER OUR IFU (INSTRUCTIONS FOR USE) BECAUSE OF OUR ANTICOAGULATION AND PURGE REQUIREMENTS. THE PATIENT WITHDREW CARE AND SUBSEQUENTLY EXPIRED ON (B)(6) 2026. THE PATIENT¿S DEATH IS CONSERVATIVELY REPORTED BUT LIKELY UNRELATED TO DEVICE PERFORMANCE BUT RATHER THE PATIENT¿S CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112917 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026792261 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1