BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA

    MDR report key: 25171342 · Received May 14, 2026

    Report

    Report Number
    1220648-2026-07817
    Event Type
    Malfunction
    Date Received
    May 14, 2026
    Date of Event
    May 7, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    04260113630303
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS ONE OF TWO RELATED REPORTS. THIS REPORT REPRESENTS THE GUIDEWIRE AND ANOTHER REPORT WILL BE SUBMITTED TO REPRESENT THE IMPELLA CP. 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 WAS RECEIVED. WHEN THE CLINICAL CONSULTANT LEFT THE HOSPITAL, THE DEVICE HAD BEEN PLACED BACK IN THE BOX. IF THE DEVICE IS STILL AVAILABLE FOR RETURN THEN IT WILL BE SENT IN. D4 PRIMARY UDI NUMBER WAS REVISED.

    Additional Manufacturer Narrative · 0

    D9 DEVICE WAS RETURNED AND DATE RECEIVED WAS ADDED. H6 TYPE OF INVESTIGATION CODE WAS UPDATED DUE TO THE DEVICE BEING RETURNED. H11 UPDATED ADDITIONAL MANUFACTURER NARRATIVE DUE TO 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 RIGHT FEMORAL ARTERY TO SUPPORT AN 80-YEAR-OLD MALE PATIENT WHO HAD BEEN ADMITTED IN WITH ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK, PRESENTING IN SCAI STAGE E SHOCK. THE OTHER UNDERLYING MEDICAL HISTORY WAS NOT SHARED. THE CP WAS DELIVERED TO THE LEFT VENTRICLE FOR SUPPORT OVER THE .018 GUIDEWIRE AS PER BEST PRACTICES. THE WIRE WAS THEN BEING REMOVED, BUT THE TEAM WAS UNABLE TO DO SO. THE ENTIRE SYSTEM OF WIRE AND PUMP WERE REMOVED AND REPLACED BY A NEW 2ND CP PUMP. THE TEAM OBSERVED THE WIRE HAD KINKED AND WAS STUCK IN THE CANNULA OF THE PUMP. THE PATIENT EXPIRED ON THE 2ND DAY OF THE REPLACEMENT CP PUMP SUPPORT. THE OFFICIAL CAUSE OF DEATH HAS BEEN SHARED AS CARDIAC ARREST. THE TEAM NOTED THE CP WAS NOT ENOUGH SUPPORT, THE PATIENT'S UNDERLYING CONDITION WAS DISCUSSED WITH THE FAMILY. THE FAMILY MADE DECISION NOT TO ESCALATE AND ADD RIGHT SIDED IMPELLA SUPPORT. THE FAMILY MADE DECISION TO WITHDRAW CARE AND PATIENT EXPIRED AFTER BEING MADE A DNR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130286 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 9464335 04260113630303

    Patients

    Seq Age Sex Outcome Treatment
    1