BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA 5.5

    MDR report key: 23208987 · Received October 3, 2025

    Report

    Report Number
    1220648-2025-47139
    Event Type
    Death
    Date Received
    October 3, 2025
    Date of Event
    September 4, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER. THEREFORE, THE INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    CORRECTION D6A, D6B. THE INVESTIGATION OF THE REPORTED FAILURE MODE HAS BEEN COMPLETED. OPTICAL SENSOR ISSUE: ONGOING PLACEMENT SIGNAL LOW ALARMS REPORTED. NO RELEVANT PATIENT CONDITION OR ABNORMALITY NOTED. NO VOLUME ISSUES NOTED. THE LOGS CONFIRM PLACEMENT SIGNAL LOW ALARMS AND SHOW INITIAL PLACEMENT SIGNAL VALUE AT THE START OF SUPPORT WAS 0. THE 5S PARAMETERS WERE STABLE THROUGH SUPPORT. THE CAUSE OF THE OPTICAL SIGNAL ISSUE WAS NOT ESTABLISHED AS NO PRODUCT WAS RETURNED AND LIMITED CLINICAL INFORMATION WAS PROVIDED. PUMP SUCTION: THE DATA LOGS CONFIRM SUCTION ALARMS AND CORRECT TRIGGER. CLINICAL REPORTED SUCTION AND REPOSITIONING ATTEMPT WHICH DID NOT RESOLVE SUCTION ALARMS. NO PATIENT VOLUME ISSUES WERE NOTED NOR WAS ECMO USED. THE CAUSE OF THE SUCTION ALARMS WAS NOT ESTABLISHED AS NO PRODUCT WAS RETURNED AND LIMITED CLINICAL INFORMATION WAS PROVIDED. PAROXYSMAL ATRIAL FIBRILLATION: THE ROOT CAUSE OF THE INJURY WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. DEVICE HISTORY REVIEW: THE DEVICE PASSED ALL THE POST STERILE INSPECTION CHECKS.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED A PATIENT ON SUPPORT WITH AN IMPELLA 5.5. UPON EXCHANGE OF THE IMPELLA CP FOR AN IMPELLA 5.5, PLACEMENT SIGNAL ALARM (PSL) ACTIVE ALARM OCCURRED WHILE UTILIZING A DOUBLE BARREL TECHNIQUE. THE PSL ALARM WAS ONGOING SINCE PLACEMENT. AFTER PULLING THE PULMONARY ARTERY CATHETER AND CENTRAL LINE, THE PATIENT WENT INTO ATRIAL FIBRILLATION. MULTIPLE SUCTION ALARMS OCCURRED OVERNIGHT AND INTO THE MORNING. THE PHYSICIAN WAS CALLED TO THE BESIDE AND THE IMPELLA 5.5 WAS REPOSITIONED TO APPROXIMATELY 4.4. EVENTUALLY, CARE WAS WITHDRAWN AND THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2623053 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.5 2026719851

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Required Intervention| D