BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA 5.5

    MDR report key: 23543206 · Received November 13, 2025

    Report

    Report Number
    1220648-2025-48333
    Event Type
    Injury
    Date Received
    November 13, 2025
    Date of Event
    October 15, 2025
    Report Date
    November 13, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY NO PRODUCT WAS RETURNED FOR INVESTIGATION. FEVER: THE CAUSE OF THE CLINICAL SYMPTOM WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. DEVICE HISTORY LOT DEVICE LOT: 1872080. DEVICE HISTORY BATCH SUBCOMPONENT LOT: N/A. DEVICE HISTORY REVIEW DEVICE WITH 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

    THE COMPLAINANT REPORTED THAT A PATIENT NOTED AS HIGH-RISK OFF-PUMP TRIPLE CORONARY ARTERY BYPASS GRAFT (OPCAB) WAS IMPLANTED WITH AN IMPELLA 5.5 DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. THE IMPELLA 5.5 WAS SUCCESSFULLY PLACED WITHOUT COMPLICATIONS VIA THE AORTA AND THE OPCAB WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT TO REST AND RECOVER. ON DAY 2 OF SUPPORT, IT WAS REPORTED THAT THE PATIENT HAD A FEVER, WITH A TEMPERATURE OF 102.4 DEGREES FAHRENHEIT. BLOOD CULTURES WERE DRAWN AND IT WAS NOTED THAT ANTICOAGULATION WAS WITHHELD. THE FOLLOWING DAY, THE PATIENT¿S TEMPERATURE DROPPED TO 99.1 DEGREES FAHRENHEIT AND THE PATIENT WAS SITTING UP IN BED AND ALERT. THE DEVICE WAS EXPLANTED SUCCESSFULLY AFTER WEANING. THE EXPLANT WAS NOT CONSIDERED PREMATURE AND WAS UNRELATED TO THE REPORTED COMPLICATION. THE PATIENT'S OUTCOME AT THE TIME OF EXPLANT WAS SURVIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2248859 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.5 2025597704 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention