BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA CP

    MDR report key: 19940744 · Received August 8, 2024

    Report

    Report Number
    1220648-2024-14317
    Event Type
    Death
    Date Received
    August 8, 2024
    Date of Event
    July 10, 2024
    Report Date
    August 20, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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. 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 ACCESS SITE BLEEDING AND LIMB ISCHEMIA HAS BEEN COMPLETED. THE IMPELLA DEVICE WAS NOT RETURNED FOR EVALUATION. WITHOUT ADDITIONAL CLINICAL DETAILS, THE ROOT CAUSE OF THE REPORTED ISSUES COULD NOT BE DETERMINED. E4 SHOULD HAVE BEEN LEFT BLANK ON MANUFACTURER DEVICE REPORT 1220648-2024-14317.

    Description of Event or Problem · 0

    THE COMPLAINANT HAD A IMPELLA CP PLACED FOR SUPPORT OF A PATIENT ADMITTED IN ACUTE MYOCARDIAL INFARCTION/ CARDIOGENIC SHOCK AND WAS TRANSFERRED TO A TERTIARY CENTER FROM THE COMMUNITY. IT WAS REPORTED THAT WHILE ON SUPPORT THE PATIENT EXPIRED. LATER THE ABIOMED'S LONG-TERM OUTCOME AND QUALITY INDICATOR REGISTRY DATABASE REPORTED UPON TWO ADVERSE EVENTS IN THE SUPPORT TIME. THE DOCUMENTATION NOTED A 'DEFINITE' RELATIONSHIP OF THE PUMP TO THE ACCESS SITE BLEED AND 'PROBABLE' TO THE LIMB INJURY AND COMPARTMENT SYNDROME. THE PATIENT'S OUTCOME WAS REVIEWED BY ABIOMED'S MEDICAL SAFETY OFFICER AND IT WAS DETERMINED THAT THERE IS NOT ENOUGH EVIDENCE TO EXCLUDE THE IMPELLA DEVICE AS AN ASSOCIATED FACTOR IN THE PATIENT'S OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2395352 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2025517666 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Death