BEUDAMED
    FDA Adverse Event Death Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 21896037 · Received April 23, 2025

    Report

    Report Number
    1220648-2025-27788
    Event Type
    Death
    Date Received
    April 23, 2025
    Date of Event
    April 17, 2025
    Report Date
    July 10, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502010428
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF OPTICAL SIGNAL ISSUE HAS BEEN COMPLETED. BASED ON THE DEVICE ANALYSIS, DATA ANALYSIS, AND THE CLINICAL DETAILS; THE ROOT CAUSE FOR THE PLACEMENT SIGNAL NOT RELIABLE ALARM (OPTICAL SIGNAL ISSUE) WAS DUE TO THE DEFECTIVE OPTICAL BENCH WITH LOW SIGNAL NOT RELIABLE (SNR). B3 DATE OF EVENT WAS ERRONEOUSLY ENTERED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-27788. D4 LOT NUMBER WAS INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-27788. D6A SHOULD HAVE BEEN LEFT BLANK ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-27788. E4 SHOULD HAVE BEEN LEFT BLANK ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-27788 AS IT IS UNKNOWN IF THE INITIAL REPORTER ALSO SENT THE REPORT TO THE FOOD AND DRUG ADMINISTRATION. H5 WAS ERRONEOUSLY SELECTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-27788. H8 WAS ERRONEOUSLY SELECTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-27788.

    Additional Manufacturer Narrative · 0

    MEDICAL SAFETY REVIEW OF THE EVENT WAS COMPLETED AND NOTED THERE IS NOT ENOUGH INFORMATION TO EXCLUDE THE AUTOMATED IMPELLA CONTROLLER (AIC) AS A CONTRIBUTING FACTOR IN THE OUTCOME. OPTICAL SIGNAL ISSUE REQUIRED EXCHANGE IN AIC DEVICE, AND THERE WAS A BRIEF PERIOD OF INTERRUPTED SUPPORT TO THE PATIENT. UPDATES WERE MADE TO RESPECTIVE SECTIONS: B1, B2, H1, AND H6 CODING (HEALTH/PRODUCT PROBLEM) ACCORDINGLY GIVEN THE MEDICAL SAFETY REVIEW OUTCOME. ADDITIONALLY, UPDATES WERE MADE TO SECTION D9 AND H6 CODING (INVESTIGATION) ACCORDINGLY, AS THE AUTOMATED IMPELLA CONTROLLER DEVICE WAS RETURNED, AND AN EVALUATION IS UNDERWAY. UPON COMPLETION OF THE EVALUATION/ANALYSIS, A SUPPLEMENTAL REPORT WILL BE FILED. SECTION B5 WAS UPDATED TO INCLUDE COMPLETE DETAILS OF THE REPORTED EVENT.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED DURING USE WITH A 56 YEAR OLD MALE PATIENT, THE AO POSITION WAVEFORM ON THE CONSOLE (AIC) WAS OVERSHOT WHEN THE P VALUE WAS INCREASED TO P8 OR HIGHER. THE AIC WAS REPLACED AND THE PROBLEM WAS RESOLVED. THERE WAS NO PATIENT HARM REPORTED.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED A PATIENT WITH AN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK WAS IMPLANTED WITH AN IMPELLA CP DEVICE FOR MECHANICAL CIRCULATORY SUPPORT AND POST IMPLANT, SAME DAY, IT WAS NOTED WHEN THE P VALUE WAS INCREASED TO PERFORMANCE LEVEL P-8 OR HIGHER, THE AORTIC POSITION WAVEFORM OVERSHOT. CONSEQUENTLY, THE AUTOMATED IMPELLA CONTROLLER WAS EXCHANGED, AND THE ISSUE RESOLVED. HOWEVER, FOLLOWING, APPROXIMATELY SIX DAYS LATER THE PATIENT EXPIRED NOTED FROM CIRCULATORY FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679995 AUTOMATED IMPELLA CONTROLLER TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. AUTOMATED IMPELLA CONTROLLER 180905 00813502010428

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Required Intervention| D