BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA CP

    MDR report key: 19005657 · Received March 29, 2024

    Report

    Report Number
    1220648-2024-09059
    Event Type
    Injury
    Date Received
    March 29, 2024
    Date of Event
    March 26, 2024
    Report Date
    September 23, 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
    NV, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER AND THEREFORE, AN EVALUATION OF THE DEVICE WAS NOT POSSIBLE. UPON INVESTIGATION CLOSURE, A SUPPLEMENTAL MDR WILL BE FILED. INSTRUCTIONS FOR USE FOR THE RELATED EVENT ARE AS FOLLOWS: ASSESS ACCESS SITE FOR BLEEDING AND HEMATOMA.¿ ¿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.¿ ¿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 VASCULAR INJURY.¿

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION INTO THE ACCESS SITE BLEEDING ¿ MAJOR AND THE OPTICAL SIGNAL ISSUES HAS BEEN COMPLETED SINCE THE ORIGINAL REPORT WAS SUBMITTED. THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. THE ROOT CAUSE OF THE OPTICAL SIGNAL ISSUE AND THE ACCESS SITE BLEEDING WAS NOT DETERMINED SINCE PRODUCT WAS NOT RETURNED, SOME DATA LOGS ARE MISSING, AND THERE ARE LIMITED CLINICAL DETAILS. D6A

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF OPTICAL SIGNAL ISSUES, PER FDA RECOMMENDATION. THE INVESTIGATION HAS BEEN COMPLETED. DATA LOGS SHOW THAT ABOUT 110 HOURS INTO SUPPORT, THE PLACEMENT SIGNAL SPIKES TO 3000 MMHG, THE SIGNAL-TO-NOISE RATIO DROPS TO 0, LIGHT DECREASES, LAMP GOES TO 100. CONTRAST INCREASES IN ALTITUDE, AND GAIN INCREASES. THE ROOT CAUSE OF THE OPTICAL SIGNAL ISSUE WAS NOT DETERMINED SINCE PRODUCT WAS NOT RETURNED AND SOME DATA LOGS ARE MISSING. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE SUSPECT PRODUCT AND HISTORICAL COMPLAINT DATA WAS CONDUCTED. THIS REVIEW REVEALED THAT THE PRODUCT MET ALL MANUFACTURING RELEASE CRITERIA, AND NO PRODUCT DEFICIENCIES WERE IDENTIFIED AT THE TIME THE PRODUCT WAS MANUFACTURED AND RELEASED TO THE CUSTOMER. ALL PERTINENT INFORMATION AVAILABLE TO ABIOMED HAS BEEN SUBMITTED AT THIS TIME. B1 PRODUCT PROBLEM UPDATED. B5 UPDATED TO INCLUDE OPTICAL SIGNAL ISSUE DESCRIPTION. H6 UPDATED TO INCLUDE OPTICAL SIGNAL CODING. CORRECTIONS THAT WERE MADE FROM THE INITIAL MANUFACTURER DEVICE REPORT NUMBER. B7 OTHER RELEVANT HISTORY, INCLUDING PREEXISTING MEDICAL CONDITIONS UPDATED. D6B UPDATED. D10 CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES UPDATED. F6 AND F8 HAVE ERRONEOUS ENTRIES IN THE INITIAL REPORT - SHOULD HAVE BEEN BLANK. G1 REPORTING CONTACT EMAIL AND REPORTING CONTACT FAX NUMBER UPDATED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED A 79-YEAR-OLD MALE NOTED AS HIGH RISK PERCUTANEOUS CORONARY INTERVENTION WAS IMPLANTED WITH AN IMPELLA CP DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. IT WAS REPORTED THAT THE PATIENT DEVELOPED AN ACCESS SITE HEMATOMA AND HEPARIN WAS PUT ON HOLD. THE PATIENT WAS REPORTED AS STABLE.

    Description of Event or Problem · 0

    THE COMPLAINANT ALSO REPORTED THAT THERE WERE PLACEMENT SIGNAL ALARMS, AND THE STAFF DISABLED THE AUDIO AND MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2242115 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC IMPELLA CP 2025447076 00813502011876

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Required Intervention AUTOMATED IMPELLA CONTROLLER