BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA CP SMART ASSIST SET, EU

    MDR report key: 24544297 · Received March 9, 2026

    Report

    Report Number
    1220648-2026-04731
    Event Type
    Death
    Date Received
    March 9, 2026
    Date of Event
    February 25, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A5 AND A6 ARE UNKNOWN. 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

    ADDITIONAL INFORMATION NOTED THE IMPELLA DEVICE WAS RECEIVED, AND AN EVALUATION/ANALYSIS IS UNDERWAY. UPON COMPLETION OF THE EVALUATION/ANALYSIS, A SUPPLEMENTAL REPORT WILL BE FILED. CORRESPONDINGLY, SECTIONS D9: DEVICE RECEIVED BY MANUFACTURER WITH RECEIPT DATE AND H6: INVESTIGATION TYPE, FINDINGS AND CONCLUSION CODES WERE UPDATED ACCORDINGLY. 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

    UPON REVIEW, IT WAS IDENTIFIED THAT THE MANUFACTURER FAX (D3) WAS INADVERTENTLY OMITTED IN ERROR; THE COMPLETE FAX NUMBER HAS NOW BEEN PROVIDED. CORRECTED INFORMATION HAS BEEN PROVIDED IN D4 SERIAL NUMBER. H3 UPDATED THE DEVICE EVALUATED BY MANUFACTURER. H6 INVESTIGATION: TYPE, FINDINGS, AND CONCLUSION CODES AND H6 COMPONENT CODES WERE UPDATED ACCORDINGLY BASED ON THE COMPLETED INVESTIGATION. THE CAUSE OF THE PRIMING PROBLEM WAS NOT DETERMINED AS THE RETURNED PUMP HAD NO DEFECTS FOUND AND INSUFFICIENT CLINICAL DETAILS. THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Description of Event or Problem · 0

    AN IMPELLA CP WAS BEING PREPARED FOR USE AND PLACEMENT VIA THE FEMORAL ACCESS SITE TO SUPPORT THE 75-YEAR-OLD MALE PATIENT WHO HAD BEEN ADMITTED IN WITH THE INDICATION OF CARDIOMYOPATHY AND CARDIOGENIC SHOCK. THE PATIENT PRESENTED IN SCAI STAGE E SHOCK. UNDERLYING MEDICAL HISTORY WAS NOT SHARED. THE PRIMING OF THE PURGE FOR THE CP PUMP FAILED. TROUBLESHOOTING MEASURES DID NOT RESOLVE THE ISSUES AND SO THE TEAM REPLACED THE PUMP. THERE WAS NO HARM NOTED FROM THE REPLACEMENT AND DELAY IN SUPPORT INITIATION. THE SECOND CP WAS PLACED AND SUPPORTED FOR 1 DAY AND CARE WAS WITHDRAWN. 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 E.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243721 IMPELLA CP SMART ASSIST SET, EU TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026708906

    Patients

    Seq Age Sex Outcome Treatment
    1