BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 25071661 · Received May 4, 2026

    Report

    Report Number
    1220648-2026-07421
    Event Type
    Injury
    Date Received
    May 4, 2026
    Date of Event
    April 9, 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
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A4 IS 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

    B5 CLINICAL NARRATIVE UPDATED AND H6. MEDICAL DEVICE PROBLEM CODE WAS CORRECTED FROM A0101 TO A150204. MALFUNCTION WAS CHANGED TO SERIOUS INJURY WAS. FAILURE TO ADVANCE : THE CAUSE OF THE DELIVERY ISSUE WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IMPLANTATION OF AN IMPELLA CP WAS ABORTED DUE TO ISSUES GETTING THE WIRE THROUGH THE RED WIRE GUIDE, AND FURTHER ISSUES TRACKING OVER THE WIRE AND DELIVERING INTO THE LEFT VENTRICLE. ANOTHER PUMP WAS IMPLANTED TO CONTINUE PATIENT SUPPORT. NO PATIENT HARM WAS REPORTED.

    Description of Event or Problem · 0

    US CLINICAL NARRATIVE: AN IMPELLA CP WAS INSERTED VIA THE RIGHT FEMORAL ARTERY TO SUPPORT THE 82 YEAR OLD FEMALE WHO HAD BEEN ADMITTED IN WITH ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK, PRESENTING IN SCAI STAGE D SHOCK AT PUMP INSERTION. THE UNDERLYING MEDICAL HISTORY WAS NOT SHARED. THE CP FAILED TO FULLY ADVANCE TO THE LEFT VENTRICLE. THERE WAS ISSUES WITH THE PUMP DELIVERY OVER THE .018 GUIDEWIRE AND THROUGH THE RED LUMEN. THE TEAM DID NOT SUCCESSFULLY TRACK AND DELIVER AND SO THE PUMP WAS REMOVED AND REPLACED BY A NEW 2ND CP PUMP. THE PATIENT SURVIVED THE PUMP REPLACEMENT AND THE 2ND CP SUPPORTED TIL WEAN AND EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221397 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027859434 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1