BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 25162006 · Received May 13, 2026

    Report

    Report Number
    1220648-2026-07798
    Event Type
    Death
    Date Received
    May 13, 2026
    Date of Event
    May 8, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A5: ETHNICITY AND A6: RACE ARE 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO DOCUMENT THAT THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR INVESTIGATION. SECTION D9 HAS BEEN UPDATED TO REFLECT THAT THE PRODUCT WAS RETURNED FOR INVESTIGATION. RELATED MEDICAL DEVICE REPORTS: THIS IMPELLA CP DEVICE REPORT IS ONE OF TWO DEVICES ASSOCIATED WITH THE EVENT. REFER TO THE RELATED MANUFACTURER REPORT NUMBER AS NOTED IN SECTION H10 FOR THE MEDICAL DEVICE REPORT ON THE IMPELLA CP (PUMP 1).

    Description of Event or Problem · 0

    CLINICAL NARRATIVE: AN IMPELLA CP DEVICE WAS INSERTED VIA THE RIGHT FEMORAL ARTERY IN A 58-YEAR-OLD FEMALE PATIENT PRESENTING WITH CARDIOMYOPATHY. PATIENT'S COMORBIDITIES WERE UNKNOWN. THE PATIENT¿S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS IDENTIFIED AS SCAI SHOCK STAGE D. THE PUMP WAS PLACED AND APPEARED TO HAVE KINKED BY THE OUTLET CAGE. IT APPEARED TWISTED, SO THE DECISION WAS MADE TO REMOVE THE DEVICE AND SWAP IT OUT FOR A NEW ONE. AFTER INSERTION OF THE NEW CP DEVICE, THE PATIENT REMAINED ON SUPPORT AND EXPIRED A FEW DAYS LATER. THE DEVICE WILL BE CONSERVATIVELY REPORTED FOR DEATH; HOWEVER, THE DEATH IS MOST LIKELY ATTRIBUTED TO THE PATIENT¿S UNDERLYING CRITICAL CLINICAL CONDITION AS THEY PRESENTED IN SCAI SHOCK STAGE D.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436621 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027863682 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Death