BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA CP

    MDR report key: 21506175 · Received March 3, 2025

    Report

    Report Number
    1220648-2025-26454
    Event Type
    Death
    Date Received
    March 3, 2025
    Date of Event
    February 5, 2025
    Report Date
    April 2, 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

    MEDICAL SAFETY REVIEW OF THE EVENT NOTED THAT THE PATIENT DID NOT RECEIVE SUPPORT IN CRITICAL NEED. THERE WAS A DELAY IN TREATMENT. A NEW IMPELLA CP WAS IMPLANTED AND SUPPORTED THE PATIENT ABOUT THREE HOURS BEFORE THE PATIENTS DEMISE. THE NOTED DEVICE ISSUE MAY HAVE ADDED TO AN ALREADY COMPLEX SITUATION. THERE IS NOT ENOUGH INFORMATION TO DISSOCIATE THE DELAY IN THERAPY. B.1 REVISED AS PRODUCT PROBLEM WAS INADVERTENTLY OMITTED FROM THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-26454. B.2 REVISED TO ADD DEATH AND DATE OF DEATH AS THEY WERE INADVERTENTLY OMITTED FROM THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-26454. B.5 ADDED MEDICAL SAFETY OFFICER REVIEW AS IT WAS INADVERTENTLY OMITTED FROM THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-26454. E.1 REVISED CITY AND ADDRESS LINE 1 AS THEY WERE PREVIOUSLY ENTERED INCORRECTLY ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-26454. ADDED FACILITY NAME AS IT WAS INADVERTENTLY OMITTED FROM THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-26454. E.4 SHOULD HAVE BEEN LEFT BLANK ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-26454 AS IT IS UNKNOWN IF THE INITIAL REPORTER ALSO SENT THE REPORT TO THE FOOD AND DRUG ADMINISTRATION. F.6 AND F.8 DATES WERE REPORTED ON MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-26454 AND SHOULD NOT HAVE BEEN. G.1 REVISED REPORTING CONTACT FIRST AND LAST NAME AND MANUFACTURING SITE NAME AND ADDRESS SECTION AS THEY WERE PREVIOUSLY ENTERED INCORRECTLY ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-26454. G.2 ADDED HEALTH PROFESSIONAL AS IT WAS INADVERTENTLY OMITTED FROM THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-26454. G.3 30-DAY SHOULD HAVE BEEN SELECTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-26454 AND WAS NOT. H.1 REVISED AS IT WAS PREVIOUSLY SELECTED INCORRECTLY ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-26454 H.6 ADDED DEATH CODE AS IT WAS INADVERTENTLY OMITTED FROM THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-26454. H.10 ADDED MEDICAL SAFETY OFFICER REVIEW AS IT WAS INADVERTENTLY OMITTED FROM THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-26454.

    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

    MEDICAL SAFETY REVIEW OF THE EVENT NOTED THAT THE PATIENT DID NOT RECEIVE SUPPORT IN CRITICAL NEED. THERE WAS A DELAY IN TREATMENT. A NEW IMPELLA CP WAS IMPLANTED AND SUPPORTED THE PATIENT ABOUT THREE HOURS BEFORE THE PATIENTS DEMISE. THE NOTED DEVICE ISSUE MAY HAVE ADDED TO AN ALREADY COMPLEX SITUATION. THERE IS NOT ENOUGH INFORMATION TO DISSOCIATE THE DELAY IN THERAPY.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED A PATIENT WAS IMPLANTED WITH AN IMPELLA DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. SHORTLY AFTER IMPLANT THE FLOWS ON THE PUMP DROPPED AND THE TEAM MADE THE DECISION TO EXPLANT THE REPLACE THE PUMP. THE SECOND PUMP WAS PLACED BUT, THE PATIENT EXPIRED LATER ON THAT SECOND PUMP WHILE IN THE INTENSIVE CARE UNIT. THE TEAM NOTED THE DEATH WAS NOT DUE TO THE PUMP PER THE FIELD REP. THE SECOND PUMP SUPPORTED THE PATIENT FOR UNDER 3 HOURS BEFORE THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1345303 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2025608322 04260113630280

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention| D AUTOMATED IMPELLA CONTROLLER.