BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA LD

    MDR report key: 20813695 · Received November 30, 2024

    Report

    Report Number
    1220648-2024-24455
    Event Type
    Death
    Date Received
    November 30, 2024
    Date of Event
    March 22, 2022
    Report Date
    November 30, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502011227
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION FOR THE REPORTED LOW FLOW AND POSITIONING ISSUES HAS BEEN COMPLETED. THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER AND THEREFORE, AN EVALUATION OF THE DEVICE WAS NOT POSSIBLE. HOWEVER, CLINICAL DETAILS PROVIDED WERE SUFFICIENT TO DETERMINE A ROOT CAUSE. BASED ON THE CLINICAL ACCOUNT, THE ROOT CAUSE OF THE LOW FLOW WAS IMPROPER POSITIONING DUE TO PATIENT ANATOMY. THIS REPORT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF HISTORICAL RECORDS.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED A PATIENT IN POST CARDIOTOMY CARDIOGENIC SHOCK AND WITH LOW CARDIAC OUTPUT SYNDROME WAS IMPLANTED WITH AN IMPELLA LD FOR MECHANICAL CIRCULATORY SUPPORT. IT WAS REPORTED WHILE ON IMPELLA LD SUPPORT, THE PUMP HAD POSITIONING ISSUES WHICH CAUSED THE PUMP FLOW TO BE <1.0 L/MIN. THE PHYSICIAN REPORTED ISSUES WITH OBTAINING OPTIMAL PLACEMENT OF THE DEVICE, AND COULD NOT CORRECT THE LOW PUMP FLOW WITH REPOSITIONING. THE PHYSICIAN DECIDED TO EXPLANT THE IMPELLA LD, AND REPLACE THE DEVICE WITH AN IMPELLA 5.5. THE PATIENT UNDERWENT SURGICAL INTERVENTION TO PLACE THE IMPELLA 5.5. IT WAS NOTED THAT THE PATIENT'S CARE WAS WITHDRAWN 11 DAYS LATER AND THE PATIENT EXPIRED. THE POSITIONING ISSUES THAT REQUIRED SURGICAL INTERVENTION TO RESOLVE COULD NOT BE EXCLUDED AS A CONTRIBUTING FACTOR WITH THE LIMITED INFORMATION AT HAND, EVEN THOUGH THE PATIENT EXPIRED 11 DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2615781 IMPELLA LD TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA LD 2022119927 00813502011227

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female Death