BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 25255810 · Received May 22, 2026

    Report

    Report Number
    1220648-2026-08080
    Event Type
    Injury
    Date Received
    May 22, 2026
    Date of Event
    May 15, 2026
    Report Date
    May 21, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    B1 PRODUCT PROBLEM AND H6 MEDICAL DEVICE PROBLEM CODE A01 WAS INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT.

    Description of Event or Problem · 0

    A 78-YEAR-OLD MALE WITH A PRE-PROCEDURAL CLINICAL STATE CONSISTENT WITH SCAI SHOCK STAGE A UNDERWENT IMPELLA CP PLACEMENT VIA RIGHT FEMORAL ARTERIAL PERCUTANEOUS ACCESS FOR SUPPORT DURING HIGH-RISK PCI OF THE LEFT MAIN CORONARY ARTERY. DURING THE PROCEDURE, PUMP POSITIONING BECAME SUB-OPTIMALLY DEEP WITHIN THE LEFT VENTRICLE, AND THE PATIENT SUBSEQUENTLY EXPERIENCED RUNS OF VENTRICULAR TACHYCARDIA. REPOSITIONING OF THE DEVICE WAS ATTEMPTED UNDER IMAGING GUIDANCE; HOWEVER, THE INTERVENTIONAL CARDIOLOGIST REPORTED DIFFICULTY DUE TO CHALLENGING ANATOMY, SPECIFICALLY A SMALL AND ACUTE AORTIC ARCH, WHICH PREVENTED ADEQUATE REPOSITIONING. AS REPOSITIONING ATTEMPTS WERE UNSUCCESSFUL AND APPROPRIATE POSITIONING COULD NOT BE ACHIEVED, THE DECISION WAS MADE TO REMOVE THE DEVICE PRIOR TO COMPLETION OF PCI. BASED ON AVAILABLE INFORMATION, THE POSITIONING ISSUE (DEEP PLACEMENT) WAS NOT RESOLVED DUE TO PATIENT-SPECIFIC ANATOMICAL CHALLENGES, AND THE DEVICE WAS REMOVED AS A PRECAUTION PRIOR TO PCI CONTINUATION. THE EVENT TACHYCARDIA APPEARS TO BE RELATED TO PUMP POSITIONING BECOMING SUB-OPTIMALLY DEEP WITHIN THE LEFT VENTRICLE. THE PATIENT SURVIVED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576833 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027898859 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1