BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP 371 14F LT CMR SET

    MDR report key: 24340860 · Received February 14, 2026

    Report

    Report Number
    1220648-2026-03185
    Event Type
    Injury
    Date Received
    February 14, 2026
    Date of Event
    December 31, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502011876
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN PROVIDED IN B5. CORRECTED INFORMATION HAS BEEN PROVIDED IN D3(MANUFACTURER FAX). UPON REVIEW, IT WAS IDENTIFIED THAT THE INFORMATION WAS INADVERTENTLY NOT SUBMITTED IN THE INITIAL REPORT. THE CAUSE OF THE HEMODYNAMIC INSTABILITY WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. THE CAUSE OF THE FAILURE TO ADVANCE WAS DETERMINED TO BE PATIENT CONDITION AS THE PATIENT HAD SMALL AORTIC ARCH PREVENTING SUCCESSFUL DELIVERY OF IMPELLA.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: THE CAUSE OF THE HEMODYNAMIC INSTABILITY WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. THE CAUSE OF THE FAILURE TO ADVANCE WAS DETERMINED TO BE PATIENT CONDITION AS THE PATIENT HAD SMALL AORTIC ARCH PREVENTING SUCCESSFUL DELIVERY OF IMPELLA. DEVICE HISTORY LOT: DEVICE LOT : 1800974. DEVICE HISTORY BATCH: SUBCOMPONENT LOT : N/A. DEVICE HISTORY REVIEW: THE PUMP SN (B)(6) 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.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION INDICATES "PATIENT ANATOMY WAS NOT CONDUCIVE TO PUMP PLACEMENT."

    Description of Event or Problem · 0

    A 53-YEAR-OLD PATIENT WITH KNOWN DIABETES MELLITUS AND LOW CARDIAC OUTPUT SYNDROME/POST-CARDIOTOMY CARDIOGENIC SHOCK AFTER CORONARY ARTERY BYPASS GRAFTING, WITH A LEFT VENTRICULAR EJECTION FRACTION OF 20%, WAS INITIALLY INTENDED TO RECEIVE AN IMPELLA 5.5 DEVICE. A COMPLAINT WAS FILED STATING THAT THE DEVICE COULD NOT BE PLACED SURGICALLY DUE TO A SHORT AORTA AND LIMITED AVAILABLE SPACE, AND THE PATIENT¿S AXILLARY ARTERY WAS DESCRIBED AS NOT BEING AN OPTION. THE IMPELLA 5.5 DEVICE WAS REMOVED, AND AN IMPELLA CP DEVICE WAS THEN CONSIDERED FOR INSERTION. HOWEVER, THE SECOND DEVICE WAS ALSO UNABLE TO PASS THROUGH THE VASCULATURE AND HAD TO BE REMOVED. ACCORDING TO THE IMPELLA CP AND 5.5 INSTRUCTIONS FOR USE, THIS INSERTION TECHNIQUE REPRESENTS AN OFF-LABEL APPLICATION. INSUFFICIENT INFORMATION IS AVAILABLE ON THE PATIENT, AND THE OUTCOME REMAINS UNCLEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560480 PUMP 371 14F LT CMR SET TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 PUMP 371 14F LT CMR SET 2025502105 00813502011876

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Required Intervention