BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 24446357 · Received February 25, 2026

    Report

    Report Number
    1220648-2026-03929
    Event Type
    Death
    Date Received
    February 25, 2026
    Date of Event
    February 16, 2026
    Report Date
    March 27, 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
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY. HEMODYNAMIC INSTABILITY: THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. DEVICE IN WRONG POSITION: THE CAUSE OF THE POSITIONING ISSUE MOST LIKELY USE RELATED TO PATIENT MOVEMENT AS DEVICE WAS NOTED TO BE OUT OF POSITION POST HOSPITAL TRANSFER.

    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 IMPELLA CP DEVICE WAS INSERTED VIA THE RIGHT FEMORAL ARTERY IN A 66-YEAR-OLD MALE PATIENT PRESENTING WITH ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK (AMI/CGS), SCAI SHOCK STAGE E. THE PATIENT HAD A HISTORY OF CORONARY ARTERY DISEASE AND WAS TRANSFERRED TO (B)(6) HOSPITAL FOR A HIGHER LEVEL OF CARE. ON ARRIVAL, IMPELLA CP POSITIONING WAS VERIFIED, AND THE INLET WAS NOTED TO BE IN THE MITRAL STRUCTURE. LABORATORY VALUES SHOWED LDH GREATER THAN 7500 AND PLASMA FREE HEMOGLOBIN OF 58, THOUGH SAMPLES WERE NOT HEMOLYZING AND NO HEMATURIA WAS OBSERVED. IN THE SETTING OF WORSENING CARDIOGENIC SHOCK AND SUBOPTIMAL IMPELLA CP POSITIONING, THE TEAM ELECTED TO ESCALATE SUPPORT TO AN IMPELLA 5.5. THE IMPELLA CP WAS REMOVED. AFTER ESCALATION TO THE IMPELLA 5.5, CARE WAS SUBSEQUENTLY WITHDRAWN, AND THE PATIENT EXPIRED. THE REPORTED EVENTS ARE POSITIONING ISSUE, MEDICAL DEVICE REMOVAL, DEVICE REVISION OR REPLACEMENT, HEMODYNAMIC INSTABILITY, AND DEATH. THE DEATH IS CONSERVATIVELY BEING REPORTED TO THE IMPELLA CP BUT IS UNLIKELY A CONTRIBUTING FACTOR AND IS MOST LIKELY ATTRIBUTED TO THE PATIENT¿S UNDERLYING CRITICAL CONDITION AS THEY PRESENTED IN SCAI STAGE E SHOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507147 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026811967 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Death