BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24924518 · Received April 20, 2026

    Report

    Report Number
    1220648-2026-06960
    Event Type
    Injury
    Date Received
    April 20, 2026
    Date of Event
    April 7, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502011678
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VESSEL PERFORATION : THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. ASAE/ HEMATOMA : THE CAUSE OF THE ACCESS SITE ADVERSE EVENT WAS USE RELATED AS BLEEDING WAS CAUSED BY CLOSURE DEVICE/SUTURE FAILURE REQUIRING SURGICAL ARTERIAL REPAIR.

    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

    AN IMPELLA CP DEVICE WAS INSERTED INTO THE LEFT FEMORAL ARTERY IN A 62-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). THE DEVICE WAS SUCCESSFULLY WEANED IN THE PROCEDURE ROOM. UPON EXPLANT, THE PERCLOSE STRING BROKE AND A LARGE HEMATOMA FORMED. AN 8FR ANGIOSEAL WAS ATTEMPTED TO BE PLACED, BUT WAS UNSUCCESSFUL. A 14FR NON-ABIOMED SHEATH (COOK) WAS PLACED AND A CARDIOVASCULAR (CV) SURGEON WAS CONSULTED TO REMOVE THE SHEATH AND SURGICALLY REPAIR THE ARTERY. IT WAS NOTED THAT THE PATIENT WAS ON AN ANGIOMAX DRIP DURING THE PROCEDURE. THE POST-PROCEDURE OUTCOME IS SURVIVED AT EXPLANT. THE IMPELLA FUNCTIONED AS INTENDED. VASCULAR INJURY IS LISTED AS A POTENTIAL ADVERSE EVENT, AND CONSISTENT WITH KNOWN DEVICE-RELATED, PATIENT-RELATED FACTORS AND/OR CAN BE ATTRIBUTED TO USER TECHNIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    986487 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 S9998669 00813502011678

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention