BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA 5.5

    MDR report key: 19220014 · Received May 1, 2024

    Report

    Report Number
    1220648-2024-10617
    Event Type
    Injury
    Date Received
    May 1, 2024
    Date of Event
    March 18, 2024
    Report Date
    June 7, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B5 AND H6 HAS BEEN UPDATED AS PER ADDITIONAL INFORMATION RECEIVED.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION FOR THE REPORTED VENTRICULAR TACHYCARDIA (VT), HEMOLYSIS, AND THROMBOCYTOPENIA HAS BEEN COMPLETED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. CLINICAL DETAILS WERE INSUFFICIENT TO DETERMINE THE ROOT CAUSE OF THE THROMBOCYTOPENIA AND THE VT. HOWEVER, BASED UPON CLINICAL DETAILS, THE ROOT CAUSE OF THE HEMOLYSIS WAS PATIENT CONDITION RELATED AND UNRELATED TO IMPELLA SINCE THE HEMOLYSIS BEGAN TO DEVELOP FIVE DAYS AFTER IMPELLA REMOVAL. THE INSTRUCTIONS FOR USE REFERENCED IN THE INITIAL REPORT IS FOR THE IMPELLA 5.5 WITH SMARTASSIST FOR USE IN THE POTENTIAL ADVERSE EVENTS (UNITED STATES) SECTION. D4-UPDATED MODEL NUMBER

    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: ¿ARRHYTHMIA, ATRIAL FIBRILLATION, BLEEDING, CARDIAC TAMPONADE, CARDIOGENIC SHOCK, DEATH, DEVICE MALFUNCTION, HEMOLYSIS, HEPATIC FAILURE, INSERTION SITE INFECTION, PERFORATION, PHLEGMASIA CERULEA DOLENS (A SEVERE FORM OF DEEP VENOUS THROMBOSIS), PULMONARY VALVE INSUFFICIENCY, RESPIRATORY DYSFUNCTION, SEPSIS, THROMBOCYTOPENIA, THROMBOTIC VASCULAR (NON-CENTRAL NERVOUS SYSTEM COMPLICATION, TRICUSPID VALVE INJURY, VASCULAR INJURY, VENOUS THROMBOSIS, VENTRICULAR FIBRILLATION AND/OR TACHYCARDIA.¿

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED VIA ABIOMED¿S LONG-TERM OUTCOME AND QUALITY INDICATOR IMPELLA REGISTRY REGARDING A PATIENT THAT ENDURED RECURRING THROMBOCYTOPENIA WITH A "POSSIBLE" RELATIONSHIP TO THE IMPELLA DEVICE USED: ¿THE PATIENT DEVELOPED REPORTABLE THROMBOCYTOPENIA ON (B)(6) 2024. ADMISSION PLATELETS 272 K/UL, PLATELETS (B)(6) 2024 49 K/UL, LOWEST PLATELET COUNT 39 K/UL ((B)(6) 2024), AND RECOVERED ABOVE REPORTABLE THRESHOLD (B)(6) 2024 (57 K/UL). THE PATIENT EXPERIENCED RECURRING THROMBOCYTOPENIA (B)(6) 2023 WITH PLATELETS AS LOW AS 12 K/UL.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED VIA ABIOMED¿S LONG-TERM OUTCOME AND QUALITY INDICATOR IMPELLA REGISTRY REGARDING A PATIENT THAT ENDURED RECURRING HEMOLYSIS WITH A "DEFINITE" RELATIONSHIP TO THE IMPELLA DEVICE USED: ¿THE PATIENT DEVELOPED RECURRING HEMOLYSIS. ADMISSION TOTAL HEMOGLOBIN (B)(4), ADMISSION BILIRUBIN 2.4 MG/DL (LDH NOT DONE). LOWEST TOTAL HEMOGLOBIN (B)(4) ((B)(6) 2024) PEAK LDH 38298 U/L ((B)(6) 2024), PEAK BILIRUBIN (B)(4) MG/DL ((B)(6) 2024). PLASMA FREE HEMOGLOBIN PEAK WHILE ON IMPELLA SUPPORT 45.0 MG/DL ((B)(6) 2024).¿ THE PATIENT OUTCOME IS "UNKNOWN" AT THIS TIME.

    Description of Event or Problem · 0

    WE RECEIVED A NOTIFICATION FROM OUR MEDICAL SAFETY TEAM VIA LOQI (ABIOMED¿S LONG-TERM OUTCOME AND QUALITY INDICATOR IMPELLA REGISTRY), PERTAINING TO THE ABOVE CASE. IT WAS NOTED THAT VENTRICULAR TACHYCARDIA OCCURRED WITH A DEFINITE RELATIONSHIP TO THE IMPELLA 5.5 USED ON THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2143903 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.5 2025443202 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Male Life Threatening