BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 24927495 · Received April 20, 2026

    Report

    Report Number
    1220648-2026-06967
    Event Type
    Death
    Date Received
    April 20, 2026
    Date of Event
    April 13, 2026
    Report Date
    May 14, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502013054
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E050304, F2301, A150202, AND A140508 ADDED TO H6. CORRECTED DATA: D4 SERIAL NUMBER UPDATED/CORRECTED. THE INVESTIGATION IS STILL ONGOING.

    Additional Manufacturer Narrative · 0

    A4 WEIGHT 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

    CLINICAL NARRATIVE: AN IMPELLA 5.5 DEVICE WAS INSERTED SURGICALLY INTO THE RIGHT AXILLARY/SUBCLAVIAN ARTERY IN AN 82-YEAR-OLD MALE PATIENT. THE IMPELLA WAS INSERTED FOR VENTRICULAR SUPPORT DURING A CARDIOTHORACIC (CT) SURGERY. DURING THE PROCEDURE, THERE WAS A LEFT VENTRICULAR (LV) PERFORATION. A VENOUS-ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION (VA ECMO) WAS INSERTED AND THE PATIENT WAS SWITCHED TO ECPELLA. IT WAS NOTED THAT THE LEFT VENTRICULAR WALL WAS VERY THIN DUE TO VENTRICULAR SEPTAL PERFORATION (VSP), AND THE IMPELLA WAS INSERTED INTO THIS AREA CAUSING THE PERFORATION. DUE TO DIFFICULTY REPAIRING THE PERFORATION, A DO NOT ATTEMPT RESUSCITATION (DNAR) ORDER WAS ISSUED. AFTER ONE DAY ON SUPPORT, THE PATIENT EXPIRED. THE IMPELLA FUNCTIONED AT P-8 AT 4.6L/MIN AS INTENDED. CARDIAC PERFORATION (INCLUDING LV PERFORATION) IS A POTENTIAL ADVERSE EVENT, AND CONSISTENT WITH KNOWN DEVICE-RELATED AND PATIENT-RELATED FACTORS, AND/OR CAN BE ATTRIBUTED TO USER TECHNIQUE. THE IMPELLA WILL BE REPORTED FOR DEATH AS RELATED TO THE LV PERFORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357717 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027847671 00813502013054

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Death