BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA CP

    MDR report key: 18394226 · Received December 26, 2023

    Report

    Report Number
    1220648-2023-05557
    Event Type
    Death
    Date Received
    December 26, 2023
    Date of Event
    November 26, 2023
    Report Date
    November 15, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION FOR THE REPORTED STROKE HAS BEEN COMPLETED. THE DEVICE NOR SUFFICIENT CLINICAL INFORMATION WAS RETURNED FOR EVALUATION. AS THIS CLINICAL INFORMATION WAS NOT PROVIDED, THE TRUE ROOT CAUSE OF THE STROKE COULD NOT BE DETERMINED. AS NOTED IN THE IMPELLA INSTRUCTIONS FOR USE: IMPELLA CP WITH SMART ASSIST SYSTEM. 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).¿ SECTION: WARNINGS, CAUTIONS & PRECAUTIONS: ¿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.¿ A.3 REVISED AS INFORMATION WAS INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-05557. B.2 REVISED AS DATE OF DEATH WAS PREVIOUSLY ENTERED INCORRECTLY ON INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-05557. D.6A AND D.6B REVISED FROM THE INITIAL SUBMISSION OF INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-05557 IN ACCORDANCE WITH UPDATED PROCEDURES. E.1 REVISED FIRST NAME AS IT WAS PREVIOUSLY ENTERED INCORRECTLY ON INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-05557. F.6 AND F.8 DATES WERE REPORTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-05557 AND SHOULD NOT HAVE BEEN. G.1 REPORTING CONTACT FACILITY NAME WAS INADVERTENTLY LEFT OFF THE PREVIOUSLY SUBMITTED MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-05557 AND WAS ADDED. H.6 ADDED CODE 925 IN ACCORDANCE WITH UPDATED PROCEDURES SINCE THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-05557 WAS SUBMITTED. H.10 ADDITIONAL MANUFACTURER NARRATIVE INSTRUCTIONS FOR USE WERE REVISED FROM THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-05557 IN ACCORDANCE WITH UPDATED PROCEDURES.

    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: ¿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.¿

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED A PATIENT OF UNKNOWN AGE AND GENDER IN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK WAS IMPLANTED WITH AN IMPELLA DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. THE PATIENT EXPERIENCED A CEREBRAL BLEED. THE BLEED CONTRIBUTED TO VENTRICULAR PERFORATION AS WELL. THE SUPPORT HAD GONE ON FOR SEVEN DAYS FOR THE PATIENT. WHEN THE BLEED OCCURRED, THE FAMILY MADE THE CHOICE TO NOT CONTINUE SUPPORT AND THE PATIENT EXPIRED. IT IS UNKNOWN WHETHER IT IS RELATED TO IMPELLA. IMPELLA OPERATED WITHOUT ANY PROBLEMS UNTIL THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2311732 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2024397031

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown Death| O