BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 24413652 · Received February 23, 2026

    Report

    Report Number
    1220648-2026-03761
    Event Type
    Death
    Date Received
    February 23, 2026
    Date of Event
    February 12, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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.

    Additional Manufacturer Narrative · 0

    B1: ADDED PRODUCT PROBLEM, THIS WAS OMITTED IN THE INITIAL IN ERROR.

    Additional Manufacturer Narrative · 0

    D1 REVISED BRAND NAME SINCE THE INITIAL REPORT WAS SUBMITTED. THE INVESTIGATION WAS COMPLETED AND H6 CODES WERE UPDATED. INVESTIGATION SUMMARY: HEMOLYSIS/MECHANICAL INTERACTION WITH BLOOD: THE CAUSE OF THE HEMOLYSIS WAS UNABLE TO BE DETERMINED DUE TO NO PRODUCT OR DATA LOGS RETURNED FOR ANALYSIS. SEPSIS: THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Description of Event or Problem · 0

    AN IMPELLA CP DEVICE WAS INSERTED INTO THE LEFT FEMORAL ARTERY IN A 64-YEAR-OLD MALE WITH A PAST MEDICAL HISTORY OF CORONARY ARTERY DISEASE (CAD) PRESENTING IN ACUTE MYOCARDIAL INFARCTION (AMI) AND CARDIOGENIC SHOCK (CGS) IN SCAI STAGE D SHOCK ON INOTROPES, VASOPRESSORS, AND VENTILATOR SUPPORT PRIOR TO INITIATION OF SUPPORT. WHILE THE PATIENT WAS IN THE CARDIOVASCULAR INTENSIVE CARE UNIT (CVICU), HEMOLYSIS WAS SUSPECTED. PLASMA FREE HEMOGLOBIN RESULTS WERE 50 AND 100. LACTATE DEHYDROGENASE (LDH) WAS 2295. LACTATE INCREASED TO 6.0 FROM 4.4 (PRE-IMPELLA). THE PATIENT ALSO EXPERIENCED SEPSIS. CARE WAS WITHDRAWN AND THE POST-PROCEDURE OUTCOME WAS EXPIRED AT EXPLANT. THE DEVICE 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 AMI COMPLICATED BY SEPSIS AND CGS AS THEY PRESENTED IN STAGE D SHOCK. HEMOLYSIS AND SEPSIS ARE LISTED AS POTENTIAL ADVERSE EVENTS AND ARE CONSISTENT WITH KNOWN DEVICE-RELATED AND PATIENT-RELATED FACTORS DOCUMENTED IN THE INSTRUCTIONS FOR USE (IFU).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474816 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026784582 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Death