BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24651435 · Received March 20, 2026

    Report

    Report Number
    1220648-2026-05731
    Event Type
    Injury
    Date Received
    March 20, 2026
    Date of Event
    March 11, 2026
    Report Date
    April 10, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDED: D3 (MANUFACTURER FAX), D10 (CONCOMITANT). CORRECTED: D4 (CATALOG & SERIAL). NO PRODUCT WAS RETURNED FOR THIS INVESTIGATION. THE CLINICAL DETAILS SPECIFY THAT PATIENTS FRIABLE TISSUE WAS A CONTRIBUTING FACTOR TO PATIENT DEVICE INTERACTION PROBLEM. THE CAUSE OF THE DEVICE IN WRONG POSITION WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS AND NO PRODUCT RETURN.

    Additional Manufacturer Narrative · 0

    H6 UPDATED WITH A01. CORRECTED DATA. D1 BRAND NAME. THE INVESTIGATION IS STILL ONGOING.

    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.

    Description of Event or Problem · 0

    CLINICAL RATIONALE: AN IMPELLA 5.5 DEVICE WAS INSERTED SURGICALLY INTO THE RIGHT AXILLARY/SUBCLAVIAN ARTERY IN A 57-YEAR-OLD MALE PATIENT PRESENTING IN SCAI STAGE D SHOCK, ON MULTIPLE INOTROPES AND VASOPRESSORS, PRIOR TO INITIATION OF SUPPORT. THE IMPELLA 5.5 WAS INSERTED AS AN ESCALATION OF THERAPY FROM AN IMPELLA CP. THE IMPELLA WAS INSERTED FOR VENTRICULAR SUPPORT FOR A CARDIOTHORACIC (CT) SURGERY: VENTRICULAR SEPTAL DEFECT REPAIR. WHILE THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU), THE POSITION WAS NOTED TO BE TILTED TOWARD THE MITRAL VALVE. REPOSITIONING ATTEMPTED UNDER ECHOCARDIOGRAM GUIDANCE DUE TO FRIABLE TISSUE. THE IMPELLA PERFORATED THE LEFT VENTRICLE (LV) WALL REQUIRING EMERGENT EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) CANNULATION WITH SURGICAL INTERVENTION AND REMOVAL OF THE IMPELLA. THE POST-PROCEDURE OUTCOME IS SURVIVED AT EXPLANT. THE IMPELLA FUNCTIONED AT P-4 AT 1.6L/MIN AS INTENDED. CARDIAC/VENTRICULAR PERFORATION IS A POTENTIAL ADVERSE EVENT, AND CONSISTENT WITH KNOWN DEVICE-RELATED AND PATIENT-RELATED FACTORS, AND/OR CAN BE ATTRIBUTED TO USER TECHNIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259892 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027826204 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1