BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA CP

    MDR report key: 22737852 · Received August 7, 2025

    Report

    Report Number
    1220648-2025-31097
    Event Type
    Death
    Date Received
    August 7, 2025
    Date of Event
    July 24, 2025
    Report Date
    September 16, 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
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF ACCESS SITE BLEEDING, HEMOLYSIS, AND POSITIONING ISSUES HAS BEEN COMPLETED. THE IMPELLA DEVICE WAS NOT RETURNED FOR EVALUATION. DATA REVIEW: DATA LOGS CONFIRMED PUMP WAS IN IMPROPER POSITION CORRESPONDED WITH THE TIME HEMOLYSIS WAS REPORTED PER CLINICAL DESCRIPTION THAT TRIGGERED ALARMS IMPELLA POSITION IS UNKNOWN. NO OTHER ISSUES WERE FOUND ON THE LOGS. PRODUCT WAS NOT RETURNED FOR REVIEW. BASED ON CLINICAL DESCRIPTION, THE ROOT CAUSE OF ACCESS SITE BLEEDING WAS MOST LIKELY USE RELATED SINCE ACCESSING SITE WAS SECURED WITHOUT ANGLE MATCHING. THE ROOT CAUSE OF HEMOLYSIS WAS MOST LIKELY DUE TO PUMP WAS NOT IN THE PROPER POSITION SINCE IMPELLA REPOSITIONING UNIT WAS NOT LOCKED IN PLACE. THE ROOT CAUSE OF POSITIONING ISSUE WAS MOST LIKELY USE RELATED SINCE IMPELLA REPOSITIONING UNIT WAS NOT LOCKED IN PLACE.

    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. THE INSTRUCTIONS FOR USE FOR THE IMPELLA CP WITH SMART ASSIST SYSTEM STATES THE FOLLOWING: 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).¿

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE PATIENT EXPERIENCED ACCESS SITE BLEEDING A COUPLE OF HOURS AFTER BEING IN THE INTENSIVE CARE UNIT. MANUAL PRESSURE WAS HELD, AND HEPARIN WAS STOPPED. ADDITIONALLY, THE PATIENT DEVELOPED RED URINE. THE IMPELLA CP WAS TURNED DOWN TO P7 FROM P8. UNDER ECHOCARDIOGRAM IT LOOKED LIKE THE IMPELLA WAS TOO DEEP, SO IT WAS REPOSITIONED. IT WAS FURTHER REPORTED THAT CARE WAS WITHDRAWN AND THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531204 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2026694086 00813502011876

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Death| R