BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 23163385 · Received September 28, 2025

    Report

    Report Number
    1220648-2025-46938
    Event Type
    Death
    Date Received
    September 28, 2025
    Date of Event
    August 25, 2025
    Report Date
    April 28, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A140508 REMOVED FROM H6. A141203 ADDED TO H6. THE INVESTIGATION IS STILL ONGOING.

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER, THEREFORE, INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT PRESENTED WITH 100% OCCLUDED MID LEFT MAIN AND MID-LEFT ANTERIOR DESCENDING. DECISION WAS MADE TO PLACE IMPELLA CP. IT WAS NOTED THAT THE CP WAS PLACED, HOWEVER THE STAFF REPORTED THAT WHEN THE IMPELLA CP WAS STARTED, THE PUMP DID NOT GO INTO AUTO BUT RATHER STARTED AT P-0. IT WAS ABOUT 20-30 SECONDS BEFORE THE STAFF NOTICED THAT THE PATIENT WAS NOT BEING SUPPORTED. STAFF SAID THAT IT CAUSED NO HARM OR PROCEDURAL PROBLEMS, THEY JUST HAD TO TURN UP THE P-LEVEL. THE PATIENT WAS ON TWO PRESSORS AND THE PATIENT¿S LACTIC HAD RISEN. THE CRITICAL CARE TEAM PLACED A SWAN, A-LINE, HEMISPHERE, AND TRIPLE-LUMEN CATHETER, BUT BY THAT TIME THE PATIENT¿S CREATININE HAD RISEN FURTHER AND HIS LACTIC ACID WAS NOW 14.1. PHYSICIAN PREPARED TO CANNULATE TO EXTRACORPOREAL MEMBRANE OXYGENATION, HOWEVER THEY BELIEVED THE PATIENT WAS TOO FAR GONE. BY THAT POINT THE PATIENT¿S LACTIC WAS 17, THE PATIENT WAS ON 5 VASOACTIVE DRIPS AND HIS SVO2 WAS 50%. THE DECISION WAS MADE TO MEDICALLY/CHEMICALLY TREAT THE PATIENT. THE PATIENT¿S FAMILY SOON DECIDED TO WITHDRAWAL CARE AND THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146885 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 IMPELLA CP 2026674555

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention| D