BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA CP

    MDR report key: 23777222 · Received December 11, 2025

    Report

    Report Number
    1220648-2025-48924
    Event Type
    Death
    Date Received
    December 11, 2025
    Date of Event
    November 10, 2025
    Report Date
    January 21, 2026
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    04260113630280
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER. THEREFORE, THE INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED. AS NOTED IN THE IMPELLA INSTRUCTIONS FOR USE: IMPELLA CP WITH SMARTASSIST SYSTEM. SECTION: POTENTIAL ADVERSE EVENTS (UNITED STATES). ¿ACUTE RENAL DYSFUNCTION, AORTIC VALVE INJURY, BLEEDING, CARDIOGENIC SHOCK, CEREBRAL VASCULAR ACCIDENT/STROKE, DEATH, HEMOLYSIS, LIMB ISCHEMIA, MYOCARDIAL INFARCTION, RENAL FAILURE, THROMBOCYTOPENIA AND CARDIAC OR VASCULAR INJURY (INCLUDING VENTRICULAR PERFORATION)".

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: PPAE (ISCHEMIA): IN ORDER TO MAKE A CAUSE DETERMINATION, ALL OF THE CLINICAL DETAILS OUTLINED IN (B)(4) WOULD HAVE TO BE PROVIDED. THE ROOT CAUSE OF THE INJURY WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. DEVICE HISTORY LOT. DEVICE LOT: 1955206. DEVICE HISTORY BATCH. SUBCOMPONENT LOT: N/A. DEVICE HISTORY REVIEW: THE PUMP SN (B)(6) PASSED ALL THE POST STERILE INSPECTION CHECKS.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED A PATIENT WAS IMPLANTED WITH AN IMPELLA CP FOR MECHANICAL CIRCULATORY SUPPORT. THE PATIENT WAS UNDER IMPELLA CP SUPPORT FOR CARDIOGENIC SHOCK SECONDARY TO MYOCARDIAL INFARCTION COMPLICATED BY VENTRICULAR SEPTAL DEFECT. AFTER SIX DAYS OF UNCOMPLICATED CARE WITH THE IMPELLA CP, THE PATIENT UNDERWENT SURGERY TO RESOLVE THE MECHANICAL COMPLICATION RESULTING FROM THE HEART ATTACK. EXTREME VASOPLEGIA DEVELOPED POSTOPERATIVELY. DUE TO HIGH DOSES OF NOREPINEPHRINE, LIMB ISCHEMIA DEVELOPED, AND IT WAS DECIDED TO EXPLANT THE IMPELLA. THE PATIENT'S CONDITION DETERIORATED, AND HE DIED HOURS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2775580 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2026709043 04260113630280

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Death| R