BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA CP

    MDR report key: 23888536 · Received December 24, 2025

    Report

    Report Number
    1220648-2025-49300
    Event Type
    Death
    Date Received
    December 24, 2025
    Date of Event
    September 24, 2025
    Report Date
    February 14, 2026
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    04260113630280
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING CODES HAVE BEEN ADDED: H6 CLINICAL CODE: E0511, E0619. H6 MEDICAL DEVICE PROB CODE: A0414, A0502 AND REMOVED A0405,A051205.

    Additional Manufacturer Narrative · 0

    PATIENT-SPECIFIC INFORMATION A5. ETHNICITY AND A6. RACE ARE UNKNOWN AT THE TIME OF THIS MDR WRITING. SHOULD THIS INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. MEDICAL SAFETY REVIEW. MEDICAL SAFETY REVIEWED THE EVENT AND NOTED THE FOLLOWING: A SERIOUS INJURY LEADING TO DEATH ¿ DEVICE-RELATED ADVERSE EVENT. FURTHER NOTED, THE PUMP MALFUNCTION DID CONTRIBUTE TO THE CAUSE OF DEATH, AND THE MALFUNCTION WAS CAUSED BY USER. USER ERROR DURING PATIENT TRANSPORT LED TO MECHANICAL DAMAGE OF THE DEVICE CONNECTOR, CAUSING LOSS OF PUMP FUNCTION RESULTING IN PATIENT DEATH. CONTRIBUTING FACTORS ARE PATIENT'S CRITICAL CONDITION WITH DEPENDENCE ON HEMODYNAMIC SUPPORT AND LACK OF PRECAUTIONARY MEASURES DURING TRANSPORT. NOTE: THIS MSO REVIEW DOES NOT IMPACT/CHANGE THE USMDR REPORTABILITY ASSESSMENT. TYPE OF REPORTABLE EVENT REMAINS DEATH FOR USMDR. DEVICE STATUS. 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 THE INDICATION FOR USE WAS SEVERE TRIPLE VESSEL DISEASE, CARDIOGENIC SHOCK, AND AN IMPELLA CP WAS PLACED IN A PATIENT WITH SEVERE TRIPLE VESSEL DISEASE DURING A HIGH-RISK INTERVENTION. DURING THE INTERVENTION PROCEDURE, A CORONARY PERFORATION OCCURRED, RESULTING IN A HEMODYNAMICALLY SIGNIFICANT PERICARDIAL EFFUSION. EMERGENCY PERICARDIAL DRAINAGE WAS PERFORMED, STABILIZING THE PATIENT. THE PERFORATION COULD NOT BE TREATED WITH A COVERED STENT DUE TO THE LESION BEING UNRECOVERABLE, AND THE PATIENT BECAME FULLY DEPENDENT ON THE IMPELLA PUMP FOR CIRCULATORY SUPPORT. A DECISION WAS MADE TO TRANSFER THE PATIENT TO CARDIAC SURGERY AT A HUB HOSPITAL. DURING TRANSPORT TO THE AMBULANCE, THE HYDRAULIC STRETCHER WAS INADVERTENTLY LOWERED WITHOUT WARNING, CAUSING THE STRETCHER TO BREAK THE IMPELLA CONNECTOR CABLE PLUG, RESULTING IN IMMEDIATE DEVICE FAILURE. THE PATIENT, WHO WAS 100% DEPENDENT ON THE DEVICE, UNFORTUNATELY PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2381140 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2026706056 04260113630280

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Required Intervention