BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA CP

    MDR report key: 23143932 · Received September 25, 2025

    Report

    Report Number
    1220648-2025-46838
    Event Type
    Death
    Date Received
    September 25, 2025
    Date of Event
    August 26, 2025
    Report Date
    September 24, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO PRODUCT WAS RETURNED. ADVERSE SITE ACCESS EVENT (HEMATOMA): THE CAUSE OF THE HEMATOMA WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. HEMOLYSIS: NO PRODUCT WAS RETURNED. AFTER REVIEWING LOGS, SUCTION ALARMS WERE OBSERVED. THE CAUSE OF HEMOLYSIS CANNOT BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS PROVIDED. PAROXYSMAL ATRIAL FIBRILLATION: IN ORDER TO MAKE A CAUSE DETERMINATION, ALL OF THE CLINICAL DETAILS OUTLINED IN ES2023-0158 WOULD HAVE TO BE PROVIDED. THE CAUSE OF THE INJURY WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. DEVICE IN WRONG POSITION (POSITIONING ISSUE): THE CAUSE OF THE POSITIONING ISSUE WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. DEVICE HISTORY REVIEW: DEVICE (SN: (B)(6)) PASSED ALL POST STERILE INSPECTION CHECKS.

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER. THEREFORE, THE INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED. AS NOTED IN THE IMPELLA INSTRUCTIONS FOR USE: IMPELLA CP WITH SMARTASSIST 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: USE OF ECHOCARDIOGRAPHY FOR POSITIONING OF THE IMPELLA CATHETER: ¿EVALUATE THE POSITION OF THE IMPELLA CATHETER IF THE AUTOMATED IMPELLA CONTROLLER DISPLAYS POSITION ALARMS OR IF YOU OBSERVE LOWER THAN EXPECTED FLOWS OR SIGNS OF HEMOLYSIS. IF THE CATHETER DOES NOT APPEAR TO BE CORRECTLY POSITIONED, INITIATE STEPS TO REPOSITION IT.¿. IMPELLA CATHETER TOO FAR INTO THE LEFT VENTRICLE: ¿OBSTRUCTION OF THE IMPELLA CATHETER INLET AREA CAN LEAD TO INCREASED MECHANICAL FORCES ON BLOOD CELL WALLS AND SUBSEQUENT HEMOLYSIS, WHICH OFTEN PRESENTS AS DARK OR BLOOD COLORED URINE.¿. SECTION: HEMOLYSIS: ¿HEMOLYSIS SHOULD BE MONITORED DURING SUPPORT. PATIENTS WHO DEVELOP HIGH LEVELS OF HEMOLYSIS MAY SHOW SIGNS OF DECREASED HEMOGLOBIN LEVELS, DARK OR BLOOD-COLORED URINE, AND IN SOME CASES, ACUTE RENAL FAILURE. PLASMA-FREE HEMOGLOBIN (PFHGB) IS THE BEST INDICATOR TO CONFIRM WHETHER A PATIENT IS EXPOSED TO AN UNACCEPTABLE LEVEL OF HEMOLYSIS¿. ¿PATIENT CONDITIONS, INCLUDING CATHETER POSITION, PRE-EXISTING MEDICAL CONDITIONS, AND SMALL LEFT VENTRICULAR VOLUMES, MAY ALSO PLAY A ROLE IN PATIENT SUSCEPTIBILITY TO HEMOLYSIS.¿. SECTION: SUCTION: ¿SUCTION MAY OCCUR IF THE BLOOD VOLUME AVAILABLE FOR THE IMPELLA CATHETER IS INADEQUATE OR RESTRICTED. SUCTION LIMITS THE AMOUNT OF SUPPORT THAT THE IMPELLA CATHETER CAN PROVIDE TO THE PATIENT AND RESULTS IN A DECREASE IN ARTERIAL PRESSURE AND CARDIAC OUTPUT. IT CAN DAMAGE BLOOD CELLS, LEADING TO HEMOLYSIS. IT MAY ALSO BE AN INDICATOR OF RIGHT HEART FAILURE.¿.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT DURING IMPELLA CP SUPPORT A HEMATOMA SUPERIOR LATERALLY TO THE IMPELLA AND SWAN SITE (LEFT GROIN) WAS NOTED. MANUAL PRESSURE WAS HELD BY THE MEDICAL DOCTOR. THE HEMATOMA WAS SOFT POST HOLD. CHANGING TO THE DRESSING WAS NOTED. THE PATIENT WAS HEMODYNAMICALLY UNSTABLE DURING AN EPISODE OF ATRIAL FIBRILLATION AND WAS TREATED WITH AMIODARONE. INOTROPES WERE INCREASED. THE INTERDISCIPLINARY TEAM DISCUSSED VIABILITY AND THE NEXT STEPS. PLAN WAS PENDING. NO HEMATOMA WAS NOTED AND REPOSITION GIVEN HEMOLYSIS AND SHOWN DEEP ON ECHOCARDIOGRAM. THE PATIENT'S FAMILY MADE THE DECISION TO WITHDRAW CARE AND THE PATIENT PASSED AWAY OVERNIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1614717 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2026703379

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Death| R