BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24661110 · Received March 23, 2026

    Report

    Report Number
    1220648-2026-05787
    Event Type
    Injury
    Date Received
    March 23, 2026
    Date of Event
    March 12, 2026
    Report Date
    April 13, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502013474
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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

    UPON REVIEW, IT WAS IDENTIFIED THAT THE MANUFACTURER FAX (D3) WAS INADVERTENTLY OMITTED IN ERROR; THE COMPLETE FAX NUMBER HAS NOW BEEN PROVIDED. H6 INVESTIGATION: TYPE, FINDINGS, AND CONCLUSION CODES AND H6 COMPONENT CODES WERE UPDATED ACCORDINGLY BASED ON THE COMPLETED INVESTIGATION. THE ROOT CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Description of Event or Problem · 0

    AN IMPELLA CP DEVICE WAS INSERTED INTO THE RIGHT FEMORAL ARTERY IN A 74-YEAR-OLD MALE PATIENT WITH A PAST MEDICAL HISTORY OF CORONARY ARTERY BYPASS GRAFT (CABG), AND CORONARY ARTERY DISEASE (CAD), PRESENTING IN SCAI STAGE A SHOCK, PRIOR TO INITIATION OF SUPPORT. THE IMPELLA WAS INSERTED FOR VENTRICULAR SUPPORT FOR A PROTECTED PERCUTANEOUS CORONARY INTERVENTION (PCI). POST-PROCEDURE, THE DEVICE WAS SUCCESSFULLY REMOVED. THE 14FR SHEATH WAS REWIRED AND PERCLOSE X 2 FAILED DUE TO CALCIUM. ATTEMPTED AN UP AND OVER DRY CLOSURE; HOWEVER THE PHYSICIAN WAS STRUGGLING TO GET THROUGH THE ENDOVASCULAR ANEURYSM REPAIR (EVAR). IT WAS NOTED THAT THERE WAS A PERFORATION DUE TO CALCIUM. A COVERED STENT WAS PLACED. THE POST-PROCEDURE OUTCOME IS SURVIVED AT EXPLANT. THE IMPELLA FUNCTIONED AS INTENDED. VASCULAR INJURY MAY BE INFLUENCED BY DEVICE-RELATED AND PATIENT-SPECIFIC FACTORS SUCH AS THE PATIENT'S CALCIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566933 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 S9998662 00813502013474

    Patients

    Seq Age Sex Outcome Treatment
    1