BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA 5.5

    MDR report key: 23526225 · Received November 11, 2025

    Report

    Report Number
    1220648-2025-48276
    Event Type
    Injury
    Date Received
    November 11, 2025
    Date of Event
    September 12, 2025
    Report Date
    November 11, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE HAS NOT BEEN RECEIVED FROM THE CUSTOMER. THEREFORE, INVESTIGATION OF THE DEVICE IS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED FROM THE REPRESENTATIVE CONFIRMS THE PATIENT SURVIVED. SECTION D1 BRAND NAME CORRECTED. SECTION D4 CATALOG NUMBER WAS CORRECTED. SECTION D4 SERIAL NUMBER WAS CORRECTED.

    Additional Manufacturer Narrative · 0

    THE PUMP WAS NOT RETURNED FOR INVESTIGATION. THE CAUSE OF THE INFLAMMATION WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. THE CAUSE OF THE ACCESS SITE BLEEDING ISSUE WAS NOT DETERMINED DUE TO LACK OF RETURNED PRODUCT FOR INVESTIGATION AND INSUFFICIENT CLINICAL INFORMATION. THE CAUSE OF THE SUCTION ISSUE WAS MOST LIKELY RELATED TO PATIENT CONDITION, BASED ON CLINICAL DETAILS AND RETURNED LOG ANALYSIS. THE CAUSE OF THE OPTICAL SIGNAL ISSUE WAS NOT DETERMINED SINCE THE PRODUCT WAS NOT RETURNED. THE PUMP PASSED ALL POST STERILE INSPECTION CHECKS.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THEY ENCOUNTERED A PLACEMENT SIGNAL ISSUE, PUMP SUCTION AND THAT THE PATIENT HAD ACCESS SITE BLEEDING AND RIGHT ARM SWELLING DURING IMPELLA 5.5 SUPPORT. IT WAS REPORTED THAT THE ¿PLACEMENT SIGNAL NOT RELIABLE¿ ALARM ALARMED THREE TIMES ON NIGHT SHIFT PER RN (REGISTERED NURSE) AND THAT IT WAS CONFIRMED VIA IMPELLA CONNECT. LATER, PATIENT HAD SWELLING IN RIGHT ARM SO PLANS WERE MADE FOR DUPLEX TODAY TO ASSESS FOR CLOT, BUT NO FURTHER MENTION OF CLOT WAS MADE. ACCESS SITE BLEEDING WAS ALSO NOTED AND A FEW DAYS LATER OOZING WAS NOTED AGAIN. THE DRESSING WAS CHANGED. OOZING WAS ALSO NOTED FROM INCISION SITE WHERE GRAFT WAS HANGING OUT OF BODY. NO HEMATOMA. FINALLY, PATIENT ENCOUNTERED SUCTION ALARMS BUT AFTER 2 UNITS OF PACKED RED BLOOD CELLS, THE PUMP WAS ABLE TO GO BACK UP TO P7.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2502475 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.5 2025473835 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Required Intervention