BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA CP

    MDR report key: 20097537 · Received August 29, 2024

    Report

    Report Number
    1220648-2024-17247
    Event Type
    Death
    Date Received
    August 29, 2024
    Date of Event
    October 25, 2022
    Report Date
    August 29, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION FOR THE REPORTED SEPSIS AND ACCESS SITE BLEED HAS BEEN COMPLETED. THE DEVICE NOR SUFFICIENT CLINICAL INFORMATION WAS RETURNED FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE SEPSIS AND ACCESS SITE BLEED COULD NOT BE DETERMINED. AS NOTED IN THE IMPELLA IFU: ACCESS SITE BLEEDING: 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).¿ INFECTION/SEPSIS: IMPELLA 5.5 WITH SMARTASSIST FOR USE DURING CARDIOGENIC SHOCK & CP WITH SMARTASSIST: SECTION: TABLE 3.2 IMPELLA CATHETER COMPONENTS: ¿THE INFUSION FILTER PREVENTS BACTERIAL CONTAMINATION AND AIR FROM ENTERING THE PURGE LUMEN.¿ SECTION: WARNINGS & CAUTIONS: WARNINGS: ¿TO REDUCE THE POSSIBILITY OF FIBERS BEING DRAWN INTO THE IMPELLA, CUSTOMERS SHOULD AVOID EXPOSING THE INLET AND CANNULA SECTION OF THE IMPELLA HEART PUMPS TO ANY SURFACES OR FLUID BATHS WHERE THE DEVICE CAN COME INTO CONTACT WITH LOOSE OR FLOATING FIBERS.¿ THIS REPORT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF HISTORICAL RECORDS.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED A PATIENT NOTED AS HIGH-RISK PERCUTANEOUS CORONARY INTERVENTION WAS IMPLANTED WITH AN IMPELLA CP DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. FOLLOWING IMPELLA IMPLANT, THE PATIENT DEVELOPED SEPSIS AND HAD OOZING AT THE ACCESS SITE. THESE WERE MANAGED BY EXPLANTING THE IMPELLA AND INSERTING AN INTRA-AORTIC BALLOON PUMP (IABP). THE PATIENT ULTIMATELY EXPIRED. MEDICAL SAFETY REVIEW OF THE EVENT NOTED THERE IS NOT ENOUGH INFORMATION TO EXCLUDE THE IMPELLA DEVICE AS AN ASSOCIATED FACTOR IN THE PATIENT'S DEMISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1765573 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2023202569

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention| D