BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 25174801 · Received May 14, 2026

    Report

    Report Number
    1220648-2026-07847
    Event Type
    Injury
    Date Received
    May 14, 2026
    Date of Event
    May 11, 2026
    Report Date
    May 14, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    PYX
    UDI-DI
    00813502012811
    PMA / PMN Number
    P170011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    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.

    Additional Manufacturer Narrative · 0

    E4 WAS INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT.

    Description of Event or Problem · 0

    AN IMPELLA RP FLEX DEVICE WAS INSERTED SURGICALLY INTO THE RIGHT INTERNAL JUGULAR VEIN IN A 66-YEAR-OLD MALE PATIENT WITH A PAST MEDICAL HISTORY OF DIABETES, PRESENTING IN SCAI STAGE E SHOCK, ON A LEFT VENTRICULAR ASSIST DEVICE (LVAD), ON MULTIPLE INOTROPES AND VASOPRESSORS, AND ON BILEVEL POSITIVE AIRWAY PRESSURE (BIPAP) CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP), FOR RESPIRATORY SUPPORT, PRIOR TO INITIATION OF SUPPORT. THE IMPELLA WAS INSERTED FOR VENTRICULAR SUPPORT POST-OPERATIVELY CARDIOTHORACIC (CT) SURGERY. THE IMPELLA WAS PLACED DUE TO RIGHT HEART FAILURE. WHILE THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU), THE IMPELLA FLOWS DECREASED SUDDENLY TO 1LPM. IT WAS REPORTED THAT THE PHYSICIAN REPOSITIONED THE DEVICE PRIOR TO THE FLOW DROP. FLOWS CONTINUED TO DROP, SO A DECISION WAS MADE TO REMOVE THE DEVICE. THE POST-PROCEDURE OUTCOME IS SURVIVED AT EXPLANT. THE IMPELLA FUNCTIONED AT P-7 AT 2.5 L/MIN AS INTENDED. THE IMPELLA IS BEING CONSERVATIVELY REPORTED DUE TO THE EARLY EXPLANT OF THE DEVICE; HOWEVER, THE REMOVAL WAS PERFORMED WITH NO CLINICAL CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311976 IMPELLA TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP PYX ABIOMED, INC. - 1220648 2027827065 00813502012811

    Patients

    Seq Age Sex Outcome Treatment
    1