BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA 5.5

    MDR report key: 19143296 · Received April 19, 2024

    Report

    Report Number
    1220648-2024-10123
    Event Type
    Injury
    Date Received
    April 19, 2024
    Date of Event
    October 27, 2023
    Report Date
    May 1, 2024
    Manufacturer
    ABIOMED, INC
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION INTO THE ACCESS SITE BLEEDING ¿ MINOR AND THE VF/VT/AF/AT ISSUES HAS BEEN COMPLETED SINCE THE ORIGINAL REPORT WAS SUBMITTED. THE DEVICE WAS NOT RETURNED BY THE USER FACILITY FOR INVESTIGATION. THE ROOT CAUSE OF THE ACCESS SITE BLEEDING CANNOT BE DETERMINED SINCE THE PRODUCT WAS NOT DETERMINED AND INSUFFICIENT CLINICAL DETAILS WERE PROVIDED. AS THE NECESSARY CLINICAL INFORMATION WAS NOT PROVIDED AND THE DEVICE WAS NOT RETURNED, THE ROOT CAUSE OF THE VT/VF WAS NOT DETERMINED. POTENTIAL ADVERSE EVENTS (UNITED STATES). ¿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, CARDIAC OR VASCULAR INJURY (INCLUDING VENTRICULAR PERFORATION), VENOUS THROMBOSIS, VENTRICULAR FIBRILLATION AND/OR TACHYCARDIA.¿ TO CONFORM WITH UPDATED PROCEDURES, SECTIONS D6 & H10 HAVE BEEN REVISED WITH UPDATED INFORMATION.

    Description of Event or Problem · 0

    A NOTIFICATION WAS RECEIVED LONG-TERM OUTCOME AND QUALITY INDICATOR IMPELLA REGISTRY THAT THE PATIENT ENDURED VENTRICULAR TACHYCARDIA (VT) STORM WITH A POSSIBLE RELATIONSHIP TO THE IMPELLA 5.5 DEVICE. SUBJECT ADMISSION COURSE WAS COMPLICATED BY ONSET OF VENTRICULAR TACHYCARDIA STORM. THE PATIENT HAD TORSADES, NO CHEST COMPRESSIONS, SHOCKED, THEN HAD VENTRICULAR FIBRILLATION. A PROCEDURE OF STELLATE GANGLION BLOCK WAS PERFORMED, ONGOING ORAL AMIODARONE AND MEXILTINE AS NEEDED THROUGHOUT COURSE. THE PATIENT WAS ULTIMATELY BRIDGED TO LEFT VENTRICULAR ASSIST DEVICE (LVAD).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035371 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC IMPELLA 5.5 2024394647 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Male Required Intervention