BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA CP

    MDR report key: 19700658 · Received July 9, 2024

    Report

    Report Number
    1220648-2024-13001
    Event Type
    Injury
    Date Received
    July 9, 2024
    Date of Event
    January 2, 2024
    Report Date
    August 14, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502011876
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION VENTRICULAR FIBRILLATION/VENTRICULAR TACHYCARDIA (VF/VT) HAS BEEN COMPLETED. THE IMPELLA DEVICE WAS NOT RETURNED FOR EVALUATION. AS THE NECESSARY INFORMATION WAS NOT PROVIDED, THE ROOT CAUSE OF THE VT/VF WAS NOT DETERMINED. B.2 OUTCOMES ATTRIBUTED TO ADVERSE EVENT WAS REVISED AS SELECTION WAS INADVERTENTLY OMITTED FROM THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-13001. B.3 DATE OF EVENT WAS REVISED AS IT WAS ENTERED INCORRECTLY ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-13001. B.7 INFORMATION WAS ADDED AS IT WAS INADVERTENTLY OMITTED FROM THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-13001. G.1 REVISED MANUFACTURING SITE NAME AND ADDRESS SECTION AS PREVIOUSLY ENTERED INCORRECTLY ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-13001. H.6 CODE 4755 AND 4114 WERE REPORTED INCORRECTLY. NEW CODES WERE ADDED. H.10 ADDITIONAL MANUFACTURER NARRATIVE ON THE PREVIOUSLY SUBMITTED MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-13001 STATED THAT THE DEVICE WAS NOT RETURNED BUT THE DEVICE WAS DISCARDED. TYPE OF INVESTIGATION CODES HAS BEEN UPDATED TO REFLECT DISCARDED. ADDITIONAL MANUFACTURER NARRATIVE INSTRUCTIONS FOR USE (IFUS) WERE REPORTED ON THE PREVIOUSLY SUBMITTED MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-13001 INCORRECTLY. NO IFUS ARE NEEDED TO BE REPORTED FOR THIS REPORT IN ACCORDANCE WITH UPDATED PROCEDURES.

    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: SECTION: 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.¿

    Description of Event or Problem · 0

    WE RECEIVED A NOTIFICATION VIA ABIOMED¿S LONG-TERM OUTCOME AND QUALITY INDICATOR IMPELLA REGISTRY REGARDING A PATIENT THAT ENDURED VENTRICULAR TACHYCARDIA/VENTRICULAR FIBRILLATION ARREST WITH A "POSSIBLE" RELATIONSHIP TO THE IMPELLA DEVICE USED: ¿VT/VF ARREST IN SETTING OF HYPOKALEMIA WITH 45 MIN OF CPR. SUPPORTED WITH ECMO (EXTRACORPOREAL MEMBRANE OXYGENATION) AND TAKEN TO CATH LAB. RECURRENT BRACHY CARDIA MEDIATED VT AFTER CATHETERIZATION. STOPPED IV AMIODARONE AND PLACED TEMPORARY PACEMAKER. PATIENT ON IV LIDOCAINE.¿ THE PATIENT RECOVERED WITH NO SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1269271 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2024424183 00813502011876

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Life Threatening| R