BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA 5.5 WITH SMARTASSIST S2 SET, US

    MDR report key: 24208932 · Received January 29, 2026

    Report

    Report Number
    1220648-2026-01836
    Event Type
    Injury
    Date Received
    January 29, 2026
    Date of Event
    January 20, 2026
    Report Date
    February 2, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: FAILURE TO ADVANCE: THE CAUSE OF THE DELIVERY ISSUE WAS DETERMINED TO BE PATIENT CONDITION RELATED TO THE PATIENT¿S TORTUOUS ANATOMY. HEMODYNAMIC INSTABILITY: THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. DEVICE HISTORY LOT. DEVICE LOT: 1974040. DEVICE HISTORY BATCH. SUBCOMPONENT LOT: N/A. DEVICE HISTORY REVIEW: THIS PUMP SN (B)(6) PASSED ALL 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.

    Description of Event or Problem · 0

    A 73 YEAR OLD MALE UNDERGOING MECHANICAL CIRCULATORY SUPPORT FOR ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK REQUIRED IMPELLA THERAPY. THE DEVICE WAS UNABLE TO BE ADVANCED PAST THE INNOMINATE ARTERY DUE TO SIGNIFICANT VESSEL TORTUOSITY, IDENTIFIED AS THE LOCATION OF RESISTANCE. NO PRODUCT DAMAGE WAS REPORTED, NO PRODUCT RETURN WAS INDICATED, AND NO PATIENT HARM OCCURRED. THE 5.5 WAS SUBSEQUENTLY ABORTED AND A IMPELLA CP WAS IMPLANTED. THE REPORTED EVENT IS CONSISTENT WITH A DELIVERY CHALLENGE RELATED TO PATIENT SPECIFIC VASCULAR TORTUOSITY RATHER THAN DEVICE MALFUNCTION. THE INABILITY TO ADVANCE THE IMPELLA 5.5 APPEARS ATTRIBUTABLE TO ANATOMICAL RESISTANCE, AND THERE IS NO ALLEGATION OF DEVICE PERFORMANCE ISSUES AT THIS TIME. THE IMPELLA 5.5 WILL BE CONSERVATIVELY REPORTED FOR HEMODYNAMIC INSTABILITY DUE TO TEMPORARY HEMODYNAMIC SUPPORT INTERRUPTION DURING THE EXCHANGE HOWEVER THE EXCHANGE WAS PERFORMED WITH NO CONSEQUENCE TO THE PATIENT AND SUPPORT WAS RESUMED WITHOUT ANY KNOWN ADVERSE EVENTS. THE PATIENT SURVIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274431 IMPELLA 5.5 WITH SMARTASSIST S2 SET, US TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026741805 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention