BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA 5.5

    MDR report key: 23085046 · Received September 18, 2025

    Report

    Report Number
    1220648-2025-46574
    Event Type
    Injury
    Date Received
    September 18, 2025
    Date of Event
    August 19, 2025
    Report Date
    April 1, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502013276
    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

    CORRECTION: G1 MANUFACTURING SITE NAME AND ADDRESS. THE INVESTIGATION OF THE REPORTED FAILURE MODE HAS BEEN COMPLETED. UNABLE TO DELIVER OR ADVANCE: THE CAUSE OF THE DELIVER ISSUE WAS DETERMINED TO BE PATIENT CONDITION AS THE PATIENT HAD AN ANATOMICAL NARROWING DIRECTLY ON THE ANASTOMOSIS, PREVENTING SUCCESSFUL DELIVERY OF IMPELLA. DEVICE HISTORY REVIEW: THE DEVICE PASSED ALL THE POST STERILE INSPECTION CHECKS.

    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.

    Additional Manufacturer Narrative · 0

    B1, B5, AND H1 UPDATED.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED A PATIENT IN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK WAS TRIED TO BE IMPLANTED WITH AN IMPELLA 5.5 DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. THE NATIVE ANATOMY PRECLUDED THE PLACEMENT OF THE 5.5 AND SO THE TEAM MADE DECISION TO PLACE A CP. NO PATIENT HARM WAS REPORTED DUE TO THE ISSUE.

    Description of Event or Problem · 0

    UPDATED CLINICAL RATIONALE: AN IMPELLA 5.5 WAS BEING INSERTED VIA THE AXILLARY GRAFT SITE TO SUPPORT THE 72 YEAR OLD MALE PATIENT WHO HAD BEEN ADMITTED IN WITH ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK, PRESENTING IN SCAI STAGE E SHOCK. THE PATIENT WAS PLACED ON AN EXTRA-CORPOREAL MEMBRANE OXYGENATION (ECMO) ALSO. THE PATIENT WAS ON INOTROPES, VASOPRESSORS, AND A VENT FOR RESPIRATORY NEEDS PRIOR. THE PATIENT WAS UNABLE TO COME OFF OF THE HEART LUNG MACHINE IN THE OPERATING SUITE AND NEEDED THE HEMODYNAMIC SUPPORT. THE NATIVE ANATOMY DID NOT ALLOW THE 5.5 TO BE DELIVERED, AS THERE WAS THOUGHT TO BE PROBABLY AN ANATOMICAL NARROWING DIRECTLY ON THE ANASTOMOSIS. THE TEAM REMOVED THE 5.5 AND INSTEAD PLACED AN IMPELLA CP. THE EXCHANGE FROM 5.5 TO CP WAS PERFORMED WITH NO CONSEQUENCE TO THE PATIENT AND SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2874052 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 IMPELLA 5.5 2026709835 00813502013276

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male