BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 24779124 · Received April 3, 2026

    Report

    Report Number
    1220648-2026-06375
    Event Type
    Death
    Date Received
    April 3, 2026
    Date of Event
    March 26, 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
    SD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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

    ADDED: D3, E1. CORRECTED: D4 (SERIAL). PUMP STOP: THE CAUSE OF THE PUMP STOP ISSUE COULD NOT BE DETERMINED WITHOUT THE RETURNED PRODUCT FOR INVESTIGATION AND SUFFICIENT CLINICAL DETAILS, INCLUDING FULL DATA LOGS. HEMODYNAMIC INSTABILITY: THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Description of Event or Problem · 0

    CLINCIAL NARRATIVE: THE PATIENT WAS A 73-YEAR-OLD FEMALE WITH AN INDICATION FOR USE OF HEMODYNAMIC SUPPORT DUE TO ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK. THE PRE-SUPPORT CLINICAL CONDITION WAS CONSISTENT WITH SCAI SHOCK STAGE A. AN IMPELLA CP PUMP (SN (B)(6)) WAS IMPLANTED PERCUTANEOUSLY VIA THE RIGHT FEMORAL ARTERY ON (B)(6) 2026 AT 11:45 AM. THE DEVICE HAD BEEN IN PLACE FOR APPROXIMATELY 20 DAYS AT THE TIME OF THE EVENT. THE IMPELLA CP PUMP STOPPED AND COULD NOT BE RESTARTED LEADING TO DEVICE REMOVAL FROM THE LEFT VENTRICLE AND WITHDRAWAL OF CARE. IT IS IMPORTANT TO NOTE THAT IMPELLA CP INTENDED FOR CLINICAL USE IS UP TO 5 DAYS. DUE TO THE UNAVAILABILITY OF THE EXPLANTED PRODUCT FOR INVESTIGATION AND LIMITED DEVICE DIAGNOSTIC DATA AT THIS TIME, THE DEFINITIVE ROOT CAUSE OF THE PUMP STOPPAGE COULD HAVE BEEN CONTRIBUTED NOT FOLLOWING THE RECOMMENDED THE DAYS OF USE OF TREATMENT. THE PATIENT OUTCOME OF DEATH WAS INFLUENCED BY THE UNDERLYING CRITICAL CLINICAL CONDITION AND THE DECISION TO WITHDRAW CARE FOLLOWING THE DEVICE MALFUNCTION. FURTHER EVALUATION IS PENDING RECEIPT OF AVAILABLE CONSOLE DATA DOWNLOAD, IF OBTAINABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366084 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027820534 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1