BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 24857035 · Received April 13, 2026

    Report

    Report Number
    1220648-2026-06664
    Event Type
    Death
    Date Received
    April 13, 2026
    Date of Event
    April 6, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502013276
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D9. DATE DEVICE RETURNED TO MANUFACTURER ADDED.

    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.

    Additional Manufacturer Narrative · 0

    B5. ADDITIONAL EVENT DESCRIPTION ADDED.

    Description of Event or Problem · 0

    CLINICAL NARRATIVE: AN IMPELLA 5.5 DEVICE WAS INSERTED SURGICALLY INTO THE RIGHT AXILLARY/SUBCLAVIAN ARTERY IN A 77-YEAR-OLD MALE PATIENT PRESENTING IN POST-CARDIOTOMY CARDIOGENIC SHOCK (PCCS) AND LOW CARDIAC OUTPUT SYNDROME (LCOS), PRIOR TO INITIATION OF SUPPORT. THE IMPELLA WAS INSERTED FOR VENTRICULAR SUPPORT DURING A CARDIOTHORACIC (CT) SURGERY: CORONARY ARTERY BYPASS GRAFT (CABG). WHILE THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU), THE PHYSICIAN DID NOT SEE ANY PLACEMENT SIGNAL (PS) OR LEFT VENTRICLE (LV) CURVES AND VALUES. THE MOTOR CURRENT (MC) WAS FINE AND THE IMPELLA WAS NOTED TO BE IN THE CORRECT POSITION. THE ARTERIAL PRESSURE WAS 120/80 MMHG. THE LV REMAINED NARROW. PUMP CHANGE WAS SUGGESTED DUE TO POSSIBLE DAMAGE OF THE PS SENSOR. NINE DAYS AFTER IMPELLA INSERTION, THE FAMILY WITHDREW CARE AND THE PATIENT EXPIRED ON SUPPORT. THE IMPELLA FUNCTIONED AT P-9 AT 5.2L/MIN AS INTENDED. THE IMPELLA IS CONSERVATIVELY BEING 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 IN POST-CARDIOTOMY CARDIOGENIC SHOCK AND LOW CARDIAC OUTPUT SYNDROME.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION INDICATES "MD REPORTS NO LONGER SEEING PS AND LV CURVES AND VALUES. MC IS GOOD. IMPELLA POSITION IS CORRECT. ARTERIAL PRESSURE IS 120/80 MMHG. LV REMAINS NARROW. IT IS RECOMMENDED TO ADJUST THE IMPELLA BASED ON THESE PARAMETERS AND CONSIDER CHANGING THE PUMP. THE PS SENSOR MAY BE DAMAGED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920008 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026810811 00813502013276

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Death