BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 25283795 · Received May 26, 2026

    Report

    Report Number
    1220648-2026-08166
    Event Type
    Death
    Date Received
    May 26, 2026
    Date of Event
    May 20, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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 NARRATIVE: AN IMPELLA CP DEVICE WAS INSERTED VIA THE RIGHT FEMORAL ARTERIAL APPROACH IN A 74-YEAR-OLD FEMALE PATIENT FOR THE INDICATION OF ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK. THE PATIENT¿S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS CONSISTENT WITH SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY AND INTERVENTIONS (SCAI) STAGE E CARDIOGENIC SHOCK. DURING IMPELLA CP SUPPORT, IT WAS REPORTED THAT THE PATIENT DEVELOPED BLEEDING AT THE GROIN ACCESS SITE, REQUIRING MANUAL PRESSURE AND PLACEMENT OF A FEMSTOP. THE IMPELLA CP DEVICE WAS OPERATING AT PERFORMANCE LEVEL SEVEN, PROVIDING APPROXIMATELY 2.9 LITERS PER MINUTE OF FLOW. THE PURGE SOLUTION CONSISTED OF 5 PERCENT DEXTROSE IN WATER WITH 25 MILLIEQUIVALENTS PER LITER OF SODIUM BICARBONATE. NO ADDITIONAL CLINICAL WERE AVAILABLE. THE PATIENT EXPIRED WHILE ON IMPELLA CP SUPPORT. THE DEATH IS BEING CONSERVATIVELY REPORTED; HOWEVER, THE OUTCOME IS MOST CONSISTENT WITH THE PATIENT¿S UNDERLYING ACUTE MYOCARDIAL INFARCTION, CARDIOGENIC SHOCK (SCAI STAGE E), AND CRITICAL CLINICAL CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86387 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027843363 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1