BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 25172069 · Received May 14, 2026

    Report

    Report Number
    1220648-2026-07820
    Event Type
    Death
    Date Received
    May 14, 2026
    Date of Event
    April 30, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A5 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 WAS INSERTED INTO THE RIGHT FEMORAL ARTERY IN A 68 YEAR OLD MALE WITH KNOWN CORONARY ARTERY DISEASE (CAD) AND DIABETES (DM) FOR ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK. THE PURGE SOLUTION WAS 5% DEXTROSE IN WATER. PATIENT REPORTED TO BE IN SCAI SHOCK STAGE D. PATIENT WAS ON A VENTILATOR FOR RESPIRATORY SUPPORT AND ON MULTIPLE INOTROPES/VASOPRESSORS PRIOR TO IMPELLA DEVICE PLACMENT. WHILE IN THE CATH LAB, OOZING NOTED AT RIGHT FEMORAL ACCESS SITE. ACT WAS GREATER THAN 400 WITH PLATELETS AT 50. HEMOSTASIS WAS ACHEIVED WITH ANGLE MATCHING, FORWARD TENSION SUTURES ON BLUE BUTTERFLY, AND ULTIMATELY A FEM STOP WAS PLACED OVER SITE. AFTER FIVE DAYS ON SUPPORT, THE FAMILY WITHDREW CARE, AND THE PATIENT EXPIRED. THE IMPELLA FUNCTIONED AT P-7 AT 3.1L/MIN AS INTENDED. BLEEDING IS A KNOWN RISK DUE TO THE IMPELLA'S ANTICOAGULATION REQUIREMENTS. THE IMPELLA IS BEING CONSERVATIVELY REPORTED FOR DEATH; HOWEVER, IS UNLIKELY TO HAVE CONTRIBUTED TO THE PATIENT'S DEATH, WHICH WAS MOST LIKELY DUE TO THE CLINICAL CONDITION OF A CRITICALLY ILL PATIENT NOTED TO HAVE AN ELEVEATED ALANINE AMINOTRANSFERASE (ALT) LIVER FUNCTION READING AT 1399, WHICH COULD CONTRIBUTE TO BLOOD CLOTTING ABILITY. THIS CAN BE FURTHER COMPLICATED WITH PATIENT'S CONDITION OF ACUTE MYOCARDIAL INFARCTION AND STAGE D SHOCK. CARDIOGENIC SHOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152657 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027850956 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Death