BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA CP

    MDR report key: 19773543 · Received July 18, 2024

    Report

    Report Number
    1220648-2024-13183
    Event Type
    Death
    Date Received
    July 18, 2024
    Date of Event
    March 28, 2022
    Report Date
    October 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

    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. THIS REPORT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF HISTORICAL RECORDS.

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT HAS BEEN IDENTIFIED AS PART OF A RETROSPECTIVE REVIEW. DUE TO THE LIMITED CLINICAL INFORMATION AND LACK OF AVAILABLE DATA/PRODUCT THE ROOT CAUSE OF THIS INVESTIGATION IS NOT DETERMINED. B1 ADVERSE EVENT WAS INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-13183. B2 DEATH AND DATE OF DEATH WAS INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-13183. G1 REPORTING CONTACT EMAIL REVISED ON MANUFACTURER DEVICE REPORT 1220648-2024-13183 IN ACCORDANCE WITH UPDATED PROCEDURES. H1 TYPE OF REPORT WAS ERRONEOUSLY SELECTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-13183. H6 HEALTH EFFECT - CLINICAL CODE 4582 WAS ERRONEOUSLY ENTERED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-13183 H6 HEALTH EFFECT - IMPACT CODE 1802 AND 4629 WAS INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-13183.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED A PATIENT WAS IMPLANTED WITH AN IMPELLA CP DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. WHILE ON SUPPORT, THE IMPELLA DISLOCATED AND WAS UNABLE TO BE REPOSITIONED. ANOTHER IMPELLA CP WAS IMPLANTED. NO ADDITIONAL INFORMATION RELATED TO THE CONDITION OF THE PATIENT WAS PROVIDED.

    Description of Event or Problem · 0

    THE DECISION WAS MADE TO WITHDRAW CARE AND THE PATIENT EXPIRED. IT IS UNKNOWN IF THE USE OF THE IMPELLA WAS RELATED TO PATIENT DEATH, THUS THERE IS NOT ENOUGH EVIDENCE TO EXCLUDE IMPELLA AS AN ASSOCIATED FACTOR IN THE PATIENT'S OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1500272 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2022121938 04260113630280

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male Death