BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA CP

    MDR report key: 22457496 · Received July 9, 2025

    Report

    Report Number
    1220648-2025-30162
    Event Type
    Death
    Date Received
    July 9, 2025
    Date of Event
    June 14, 2025
    Report Date
    August 11, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502011876
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL SAFETY OFFICER REVIEW: THERE IS NOT ENOUGH EVIDENCE TO EXCLUDE THE IMPELLA CP DEVICE USED AS AN ASSOCIATED FACTOR IN THE PATIENT'S OUTCOME. 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 MANUFACTURER DEVICE REPORT WILL BE FILED. AS NOTED IN THE IMPELLA INSTRUCTIONS FOR USE: IMPELLA CP WITH SMART ASSIST SYSTEM SECTION: GENERAL PATIENT CARE CONSIDERATIONS ¿ASSESS ACCESS SITE FOR BLEEDING AND HEMATOMA.¿ SECTION: ENTERING CARDIAC OUTPUT USE OF THE REPOSITIONING SHEATH AND PEEL-AWAY INTRODUCER ¿REMOVE THE PEEL-AWAY INTRODUCER COMPLETELY FROM THE ARTERY OVER THE CATHETER SHAFT TO PREVENT TRAUMA AND SIGNIFICANT BLEEDING AND APPLY MANUAL PRESSURE ABOVE THE PUNCTURE SITE.¿ SECTION: POTENTIAL ADVERSE EVENTS (UNITED STATES) ¿ACUTE RENAL DYSFUNCTION, AORTIC VALVE INJURY, BLEEDING, CARDIOGENIC SHOCK, CEREBRAL VASCULAR ACCIDENT/STROKE, DEATH, HEMOLYSIS, LIMB ISCHEMIA, MYOCARDIAL INFARCTION, RENAL FAILURE, THROMBOCYTOPENIA AND CARDIAC OR VASCULAR INJURY (INCLUDING VENTRICULAR PERFORATION).¿

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF LOW PUMP FLOW AND ACCESS SITE BLEEDING HAS BEEN COMPLETED. THE IMPELLA DEVICE WAS NOT RETURNED FOR EVALUATION. ACCESS SITE BLEEDING: THE CAUSE OF REPORTED BLEEDING ISSUE MOST LIKELY PATIENT CONDITION RELATED SINCE BLEEDING OCCURRED IN MULTIPLE SITES. LOW PUMP FLOW: THE CAUSE OF LOW PUMP FLOW ISSUE MOST LIKELY WAS PATIENT CONDITION RELATED BECAUSE IMPELLA WAS USED AS A VENT FOR ECMO IN ADDITION TO THE BOLUS OF 25% ALBUMIN, AND ADJUSTING P-LEVEL TO BREAK SUCTION.

    Description of Event or Problem · 0

    THE PATIENT WAS INITIALLY PRESENTED TO AN OUTSIDE EMERGENCY DEPARTMENT WITH COMPLAINTS OF CHEST PAIN. A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED A TYPE A AORTIC DISSECTION WITH A DILATED AORTIC ROOT MEASURING 6.5 CENTIMETERS. DUE TO LEFT VENTRICULAR DISTENSION WHILE ON VENOARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION (VA ECMO), THE DECISION WAS MADE TO PLACE A PERCUTANEOUS IMPELLA CP FOR LEFT VENTRICULAR UNLOADING. DURING SUPPORT, THE PATIENT DEVELOPED BLEEDING AROUND THE REPOSITIONING SHEATH. A FEM-STOP WAS APPLIED FOR HEMOSTASIS, AND ONE UNIT OF PACKED RED BLOOD CELLS WAS TRANSFUSED. THE IMPELLA CP ALSO EXHIBITED INTERMITTENT SUCTION EVENTS WHICH WERE MANAGED WITH BOLUSES OF 25% ALBUMIN AND BY ADJUSTING THE P-LEVEL SETTINGS TO RELIEVE SUCTION. DUE TO PERSISTENT HEMODYNAMIC INSTABILITY, THE PATIENT WAS ESCALATED TO AN IMPELLA 5.5. THE PATIENT WAS ON IMPELLA 5.5 SUPPORT FOR 12 DAYS AND CARE WAS ULTIMATELY WITHDRAWN, AND THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147536 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2026685040 00813502011876

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Male Required Intervention| D