BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA 5.0

    MDR report key: 16660495 · Received March 31, 2023

    Report

    Report Number
    1220648-2023-01992
    Event Type
    Injury
    Date Received
    March 31, 2023
    Date of Event
    November 9, 2021
    Report Date
    October 17, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502010053
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

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

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF HISTORICAL RECORDS. D4 MODEL NUMBER WAS ERRONEOUSLY ENTERED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-01992. D6A AND D6B REVISED FROM THE INITIAL MANUFACTURER DEVICE REPORT 1220648-2023-01992 IN ACCORDANCE WITH UPDATED PROCEDURES. F6/F8-SHOULD HAVE BEEN LEFT BLANK ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-01992 IN ACCORDANCE WITH UPDATED PROCEDURES. G1 REPORTING CONTACT EMAIL REVISED ON MANUFACTURER DEVICE REPORT 1220648-2023-01992 IN ACCORDANCE WITH UPDATED PROCEDURES. H4 AND H5 WAS INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-01992. H6 COMPONENT CODE REVISED FROM THE INITIAL SUBMISSION IN ACCORDANCE WITH UPDATED PROCEDURES.

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS DISCARDED BY THE CUSTOMER AND THEREFORE, INVESTIGATION OF DEVICE WAS NOT POSSIBLE. SHOULD ANY NEW INFORMATION BE RETURNED, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION NOTED THAT PATIENT EXPERIENCED BLEEDING AND HEPARIN WAS WITHHELD.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED A 60 YEAR OLD MALE PATIENT PRESENTING FOR IMPELLA SUPPORT. THE PATIENT DEVELOPED THROMBOCYTOPENIA IN RELATIONSHIP TO THE IMPELLA DEVICE. AS TREATMENT, A PLATELET TRANSFUSION WAS DELIVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399458 IMPELLA 5.0 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.0 1452229 00813502010053

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Life Threatening| R