BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA CP

    MDR report key: 21776353 · Received April 4, 2025

    Report

    Report Number
    1220648-2025-27250
    Event Type
    Death
    Date Received
    April 4, 2025
    Date of Event
    March 11, 2025
    Report Date
    April 4, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502011463
    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 IMPELLA DEVICE WAS DISCARDED BY THE CUSTOMER AND THEREFORE, AN EVALUATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MANUFACTURER DEVICE REPORT WILL BE FILED. LITERATURE CITATION: YAMANA, F., DOMAE, K., KAWASUMI, R., SAKAMOTO, T., HATA, M., SHIRAKAWA, Y., MASAI, T., & SAWA, Y. (2023). AORTIC THROMBOSIS WITH VISCERAL MALPERFUSION DURING CIRCULATORY SUPPORT WITH A COMBINATION OF IMPELLA AND EXTRACORPOREAL MEMBRANE OXYGENATION FOR POSTCARDIOTOMY CARDIOGENIC SHOCK. JOURNAL OF ARTIFICIAL ORGANS, 26(4), 330¿334. HTTPS://DOI.ORG/10.1007/S10047-023-01382-3. 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: WARNINGS: SECTION: PRE-SUPPORT EVALUATION, SECTION: IMPELLA CP WITH SMART ASSIST CATHETER INSERTION, SECTION: AXILLARY INSERTION OF THE IMPELLA CP WITH SMART ASSIST CATHETER, SECTION: USE OF IMPELLA WITH TRANSCATHETER AORTIC VALVES: ¿IN PATIENTS WITH TRANSCATHETER AORTIC VALVES POSITION THE IMPELLA SYSTEM CAREFULLY TO AVOID INTERACTION WITH THE TRANSCATHETER AORTIC VALVE PROSTHESIS. UNINTENTIONAL INTERACTION OF THE IMPELLA MOTOR HOUSING WITH THE TAVR DEVICE MAY RESULT IN DESTRUCTION OF THE IMPELLER BLADES. THIS CAN LEAD TO SYSTEMIC EMBOLIZATION, SERIOUS INJURY, OR DEATH. IN THIS SITUATION, AVOID REPOSITIONING WHILE THE DEVICE IS RUNNING; TURN THE DEVICE TO P0 DURING REPOSITIONING OR ANY MOVEMENT THAT COULD BRING THE OUTLET WINDOWS INTO PROXIMITY TO THE VALVE STENT STRUCTURES. IF THERE IS LOW FLOW OBSERVED IN A PATIENT IMPLANTED WITH A TRANSCATHETER AORTIC VALVE PROSTHESIS, CONSIDER DAMAGE OF THE IMPELLER AND REPLACE THE IMPELLA AS SOON AS POSSIBLE.¿ "UNINTENTIONAL INTERACTION OF THE IMPELLA MOTOR HOUSING WITH THE TAVR DEVICE MAY RESULT IN DESTRUCTION OF THE IMPELLER BLADES. THIS CAN LEAD TO SYSTEMIC EMBOLIZATION, SERIOUS INJURY, OR DEATH."

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED A PATIENT WAS IMPLANTED WITH AN IMPELLA CP DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. THE PATIENT WAS SUPPORTED FOR 92 HOURS BEFORE THE PATIENT WAS EXPLANTED AND SUPPORTED BY EXTRACORPOREAL MEMBRANE OXYGENATION. IN 2025, A PUBLISHED ARTICLE WAS IDENTIFIED. THE AUTHORS NOTED THE FOLLOWING: "WE PERFORMED THE BENTALL PROCEDURE, MITRAL VALVE REPAIR, TRICUSPID ANNULOPLASTY, AND CORONARY ARTERY BYPASS GRAFT ON A 73-YEAR-OLD MAN ADMITTED WITH CONGESTIVE HEART FAILURE CAUSED BY ANNULOAORTIC ECTASIA, ALONG WITH SEVERE AORTIC AND MITRAL REGURGITATION. VA-ECMO AND IMPELLA WERE REQUIRED, SINCE THE CARDIOPULMONARY BYPASS WEANING WAS DIFFICULT. IMPELLA WAS REMOVED ON POSTOPERATIVE DAY 4. ON POSTOPERATIVE DAYS 5 AND 6, LABORATORY DATA SHOWED WORSENING RENAL DYSFUNCTION, LACTATE LEVELS, AND ACIDOSIS. CONTRAST-ENHANCED COMPUTED TOMOGRAPHY SHOWED THROMBOSIS IN THE CELIAC AND SUPERIOR MESENTERIC ARTERIES. AORTIC THROMBECTOMY WAS PERFORMED. HYPERKALEMIA, CAUSED BY A REPERFUSION INJURY, RESULTED IN VENTRICULAR FIBRILLATION. CONTINUOUS HEMODIAFILTRATION IMPROVED THE HYPERKALEMIA. HOWEVER, IRREVERSIBLE ACIDOSIS PROGRESSED, AND THE VA-ECMO FLOW RATE COULD NOT BE SUSTAINED. ON POSTOPERATIVE DAY 7, THE PATIENT DIED." NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2333638 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 1425034 00813502011463

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Death AUTOMATED IMPELLA CONTROLLER