BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA CP

    MDR report key: 21240604 · Received January 27, 2025

    Report

    Report Number
    1220648-2025-25798
    Event Type
    Death
    Date Received
    January 27, 2025
    Date of Event
    January 7, 2025
    Report Date
    March 13, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    04260113630280
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER AND THEREFORE, AN EVALUATION OF THE DEVICE WAS NOT POSSIBLE. UPON INVESTIGATION CLOSURE, A SUPPLEMENTAL MDR WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF PURGE LEAK ¿ PUMP HAS BEEN COMPLETED. NO PRODUCT RETURNED AND NO DATA LOGS. CLINICAL DETAILS REPORTED A LEAKAGE BETWEEN THE FILTER AND PRESSURE RESERVOIR. BYPASS WAS PERFORMED. THE CAUSE OF THE PURGE LEAK - PUMP WAS MOST LIKELY A LEAK FROM THE SIDEARM BUT THE EXACT LOCATION OF THE LEAK WAS UNKNOWN. AS NOTED IN THE IMPELLA INSTRUCTIONS FOR USE: IMPELLA CP WITH SMARTASSIST FOR USE DURING CARDIOGENIC SHOCK AND HIGH RISK PERCUTANEOUS CORONARY INTERVENTION. SECTION: CLEANING. ¿DO NOT CLEAN WITH OR EXPOSE ANY PART OF THE CLEAR SIDEARM OF THE IMPELLA CATHETER (E.G. INFUSION FILTER, PRESSURE RESERVOIR) TO ALCOHOL. ALCOHOL HAS BEEN SHOWN TO CAUSE CRACKS AND LEAKS IN THESE COMPONENTS. CAREFULLY READ LABELS ON COMMON SKIN PREPS AND LOTIONS TO AVOID USING ANY ALCOHOL-CONTAINING PRODUCTS IN THE AREA OF THE INFUSION FILTER OR PRESSURE RESERVOIR." ¿CLEAN THE CONNECTOR CABLE WITH 70% ISOPROPYL ALCOHOL.¿ A.1 REVISED PATIENT IDENTIFIER AS IT WAS REPORTED INCORRECTLY ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-25798. D.3 REVISED US ZIP CODE AS IT WAS INADVERTENTLY OMITTED FROM THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-25798. E.1 REVISED LAST NAME AS IT WAS REPORTED INCORRECTLY ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-25798. E.4 SHOULD HAVE BEEN LEFT BLANK ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-25798 AS IT IS UNKNOWN IF THE INITIAL REPORTER ALSO SENT THE REPORT TO THE FOOD AND DRUG ADMINISTRATION. H.4 REVISED DEVICE MANUFACTURE DATE AS IT WAS REPORTED INCORRECTLY ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-25798. H.10 INSTRUCTIONS FOR USE WERE INADVERTENTLY OMITTED FROM THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-25798.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED A PATIENT WITH CARDIOMYOPATHY WAS IMPLANTED WITH AN IMPELLA CP DEVICE FOR MECHANICAL CIRCULATORY SUPPORT AND TWO DAYS AFTER START OF SUPPORT, A LEAKAGE BETWEEN IMPELLA FILTER AND PRESSURE RESERVOIR WAS OBSERVED. PROTOCOL FOR PURGE FILTER BYPASS WAS REQUESTED. REPORTEDLY THE FOLLOWING DAY MEDICAL STAFF DECIDED TO END THERAPY DUE TO THE PATIENT'S "POOR" GENERAL CONDITION. THE RELATIONSHIP BETWEEN THE PATIENT'S OUTCOME AND THE IMPELLA DEVICE USED IS UNKNOWN. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468084 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2025592499 04260113630280

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Death