BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA CP

    MDR report key: 21047515 · Received December 31, 2024

    Report

    Report Number
    1220648-2024-25229
    Event Type
    Death
    Date Received
    December 31, 2024
    Date of Event
    December 14, 2024
    Report Date
    February 24, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    04260113630280
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION FOR THE REPORTED VENTRICULAR FIBRILLATION (VF) HAS BEEN COMPLETED. THE DEVICE NOR SUFFICIENT CLINICAL INFORMATION WAS RETURNED FOR EVALUATION. AS THE NECESSARY INFORMATION WAS NOT PROVIDED, THE ROOT CAUSE OF THE VF WAS NOT DETERMINED. B.2 REVISED DATE OF DEATH AS IT WAS PREVIOUSLY ENTERED INCORRECTLY ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-25229. H.6 CODE 4617 WAS INADVERTENTLY OMITTED FROM THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-25229 AND WAS ADDED.

    Additional Manufacturer Narrative · 0

    THE ROOT CAUSE OF THE INVESTIGATION FOR ARRHYTHMIAS SUCH AS ATRIAL FIBRILLATION (AF), VENTRICULAR FIBRILLATION, VENTRICULAR TACHYCARDIA, AND ATRIAL TACHYCARDIA COULD NOT BE DETERMINED WITHOUT ADDITIONAL CLINICAL INFORMATION OR A DEVICE RETURN. THEREFORE, THE ROOT CAUSE OF THE AF ALSO COULD NOT BE DETERMINED WITHOUT ADDITIONAL INFORMATION. B.5 THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-25229 STATED THAT THE PATIENT EXPERIENCED VENTRICULAR FIBRILLATION (VF). HOWEVER, THE CORRECT ADVERSE EVENT SHOULD HAVE BEEN NOTED AS ATRIAL FIBRILLATION (AF). D.3 REVISED US ZIP CODE AS IT WAS INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-25229, H.6 CLINICAL CODE CHANGED FROM 2130 ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-25229 TO CODE 1729 DUE TO INFORMATION MENTIONED ABOVE IN B.5 CORRECTIONS. H.10 THE COMPLETED INVESTIGATION IN THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-25229 WAS FOR VF. THE INVESTIGATION HAS BEEN UPDATED TO INCLUDE AF INSTEAD OF VF.

    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.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED A PATIENT (UNKNOWN RACE AND ETHNICITY) UNDERGOING A HIGH-RISK PERCUTANEOUS CORONARY INTERVENTION WAS IMPLANTED WITH AN IMPELLA CP DEVICE FOR MECHANICAL CIRCULATORY SUPPORT AND THE FOLLOWING DAY AFTER START OF SUPPORT, THE PATIENT EXPERIENCED VENTRICULAR FIBRILLATION AND RECEIVED CARDIOVERSION MULTIPLE TIMES. THE POSITION OF THE PUMP WAS CORRECTED, AND THE PATIENT WAS REPORTED TO BE STABLE WHILE ON IMPELLA SUPPORT. UPDATE A COUPLE OF DAYS LATER NOTED, THE PATIENT STILL SEDATED AND INTUBATED WITH THE NEED FOR CATECHOLAMINES FOR WHAT THE PHYSICIAN CONSIDERS THE CAUSE COULD BE SEPTIC STATUS. VITAL SIGNS ARE STABLE AND THE IMPELLA WAS NOTED WORKING WITHOUT ANY PROBLEMS. FOLLOWING IT WAS NOTED CATECHOLAMINES ARE SLOWING BEING REDUCED AND THE PATIENT IS NOW ON DIALYSIS. NOW DAY FIVE OF SUPPORT, THE PHYSICIAN NOTED THE FIRST SIGNIFICANT RECOVERY SIGNS WITH LESS NEED FOR CATECHOLAMINES. ACCORDING TO THE PHYSICIAN'S REPORT, NEPHROLOGICAL STATUS IS SLOWLY RECOVERING DUE TO PERMANENT DIALYSIS. NO ISSUES WERE NOTED WITH THE IMPELLA CP DEVICE. THE FOLLOWING DAY SLOW WEANING STARTED. HOWEVER, THEREAFTER, NOW SEVEN DAYS AFTER START OF SUPPORT IT WAS NOTED THE PATIENT EXPIRED DUE TO AN "OVERALL BAD" HEALTH STATE. ALTHOUGH NOTED THE PATIENT EXPIRED DAYS LATER FROM "OVERALL BAD" HEATH STATE, THE IMPELLA DEVICE CANNOT BE EXCLUDED AS A POSSIBLE CONTRIBUTING FACTOR WHEN CONSIDERING THE IMPELLA-RELATED VENTRICULAR FIBRILLATION EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1090482 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2025535848 04260113630280

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Death| R| L