BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 25172723 · Received May 14, 2026

    Report

    Report Number
    1220648-2026-07831
    Event Type
    Injury
    Date Received
    May 14, 2026
    Date of Event
    May 5, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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.

    Description of Event or Problem · 0

    IMPELLA CP WAS INSERTED VIA THE LEFT FEMORAL ARTERY IN A 59-YEAR-OLD FEMALE FOR THE INDICATION OF ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK. THE PATIENT WAS IN SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY AND INTERVENTIONS SHOCK STAGE C. DURING DEVICE PREPARATION, WHILE PLACING THE WIRE THROUGH THE EASY LUMEN, A FOREIGN BODY WAS NOTED ON THE PIGTAIL. THE PHYSICIAN EXPRESSED CONCERN THAT THE MATERIAL MAY HAVE TRAVELED TO THE MOTOR AND COULD POTENTIALLY HARM THE PATIENT. AS A PRECAUTIONARY MEASURE, THE DECISION WAS MADE TO OPEN AND PLACE A NEW IMPELLA CP DEVICE. FURTHER ASSESSMENT IDENTIFIED A SMALL BLOOD CLOT AT THE END OF THE PIGTAIL, LIKELY RELATED TO WIRE LOADING. IT WAS REPORTED THAT THE RED INTRODUCER WAS ACCIDENTALLY REMOVED PRIOR TO WIRE PLACEMENT, AND WHILE ATTEMPTING TO WIRE WITHOUT THE INTRODUCER, THE CLOT WAS OBSERVED AT THE PIGTAIL TIP. IT COULD NOT BE CONFIRMED WHETHER ANY PORTION OF THE CLOT TRAVELED THROUGH THE CANNULA TO THE MOTOR; HOWEVER, DUE TO POTENTIAL RISK, A SECOND DEVICE WAS OPENED. THE SECOND IMPELLA CP WAS SUCCESSFULLY PLACED, AND THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. THE FIRST DEVICE WAS NOT ACTIVATED. NO PATIENT COMPLICATIONS WERE REPORTED IN ASSOCIATION WITH THIS EVENT BASED ON THE AVAILABLE INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93941 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027847699 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1