BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 25084852 · Received May 5, 2026

    Report

    Report Number
    1220648-2026-07516
    Event Type
    Death
    Date Received
    May 5, 2026
    Date of Event
    April 29, 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
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP IS AVAILABLE FOR RETURN. 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

    B5 ADDITIONAL INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 0

    B5 ADDITIONAL INFORMATION WAS ADDED. D9 DEVICE WAS RECEIVED AND DATE RETURNED WAS ADDED. H6 TYPE OF INVESTIGATION CODE WAS UPDATED DUE TO THE DEVICE BEING RETURNED. H11 ADDITIONAL MANUFACTURER NARRATIVE WAS UPDATED DUE TO THE DEVICE BEING RETURNED. THE IMPELLA DEVICE WAS RETURNED, AND AN EVALUATION IS UNDERWAY. UPON INVESTIGATION CLOSURE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    CLINICAL NARRATIVE: AN IMPELLA CP WAS INSERTED VIA THE FEMORAL ARTERY TO SUPPORT THE 54-YEAR-OLD MALE PATIENT WHO HAD BEEN ADMITTED IN WITH ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK, PRESENTING IN SCAI STAGE D SHOCK. THE UNDERLYING MEDICAL HISTORY WAS NOT SHARED. THE PUMP SUPPORT WAS PLACED BUT THE PATIENT SUFFERED A CARDIAC ARREST AND REQUIRED CPR RESUSCITATION. THE ALARM OF "IN AORTA" TRIGGERED AND THE TEAM REPOSITIONED THE PUMP UNDER ECHO IMAGING AND THE FLOWS WERE NOTED BE SATURATED. THE SATURATION PROMPTED THE TEAM TO REPLACE THE CP WITH A 2ND CP PUMP. THE ACCESS SITE WAS SEEN TO HAVE A SMALL HEMATOMA. THE BLEED WAS MINOR AND NO INTERVENTION WAS DEEMED NECESSARY. WHILE ON THE 2ND PUMP THE PATIENT DID EXPIRE. THE DEATH IS CONSERVATIVELY BEING REPORTED ALTHOUGH AN UNLIKELY CONTRIBUTING FACTOR TO THE DEATH, AND MORE LIKELY THE PATIENT'S PRESENTING NATIVE CRITICAL CONDITION AS PRESENTED IN SCAI STAGE D.

    Description of Event or Problem · 0

    US CLINICAL NARRATIVE: (UPDATED 2026-5-27). WITH FURTHER INQUIRY THE TEAM DID REVEAL THE ALARM, THAT WAS OBSERVED AT THE TIME THEY SAW THE KINKED PURGE LINE, WAS FOR HIGH PURGE PRESSURE. IMPELLA FLOWS APPEARED TO BE SATURATED. TO TROUBLESHOOT THE PUMP ON P-4 WITH FLOWS AT 3.0L/MIN WAS INCREASED TO P-6 WITH 3.2L. AND FINAL RECOMMENDATION WAS TO REPLACE THE PUMP. AN IMPELLA CP WAS INSERTED VIA THE FEMORAL ARTERY TO SUPPORT THE 54-YEAR-OLD MALE PATIENT WHO HAD BEEN ADMITTED IN WITH ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK, PRESENTING IN SCAI STAGE D SHOCK. THE UNDERLYING MEDICAL HISTORY WAS NOT SHARED. THE PUMP SUPPORT WAS PLACED BUT THE PATIENT SUFFERED A CARDIAC ARREST AND REQUIRED CPR RESUSCITATION. THE ALARM OF "IN AORTA" TRIGGERED AND THE TEAM REPOSITIONED THE PUMP UNDER ECHO IMAGING AND THE FLOWS WERE NOTED BE SATURATED. THE SATURATION PROMPTED THE TEAM TO REPLACE THE CP WITH A 2ND CP PUMP. THE ACCESS SITE WAS SEEN TO HAVE A SMALL HEMATOMA. THE BLEED WAS MINOR AND NO INTERVENTION WAS DEEMED NECESSARY. WHILE ON THE 2ND PUMP THE PATIENT DID EXPIRE. THE DEATH IS CONSERVATIVELY BEING REPORTED ALTHOUGH AN UNLIKELY CONTRIBUTING FACTOR TO THE DEATH, AND MORE LIKELY THE PATIENT'S PRESENTING NATIVE CRITICAL CONDITION AS PRESENTED IN SCAI STAGE D.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED. THE IMPELLA FLOWS APPEARED TO BE SATURATED. THE CUSTOMER NOTICED A KINK IN LINE DUE TO THE PURGE ALARM, FOLLOWED BY DAMPENED WAVEFORMS. THE PUMP WAS ON P-4 WITH FLOWS AT 3.0 LITERS PER MINUTE. THE PUMP WAS INCREASED TO P-6 WITH 3.2 LITERS. IT WAS RECOMMENDED TO REPLACE THE PUMP WHICH WAS REPORTED TO HAVE BEEN DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274420 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026815848 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1