BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA CP

    MDR report key: 19261456 · Received May 7, 2024

    Report

    Report Number
    1220648-2024-10866
    Event Type
    Injury
    Date Received
    May 7, 2024
    Date of Event
    January 1, 2024
    Report Date
    October 10, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502011876
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. 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.¿

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION FOR THE REPORTED VENTRICULAR TACHYCARDIA (VT) HAS BEEN COMPLETED. THE DEVICE NOR SUFFICIENT CLINICAL INFORMATION WAS RETURNED FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE VT COULD NOT BE DETERMINED. ADDED- H6 COMPONENT CODE CORRECTIONS TO THE INITIAL MFR REPORT: D4-MODEL NUMBER. F6/F8 SHOULD HAVE BEEN LEFT BLANK.

    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 WORSENING RESPIRATORY FAILURE WITH A "POSSIBLE / DEFINITE / PROBABLE" RELATIONSHIP TO THE IMPELLA DEVICE USED: ¿PATIENT WAS POSITIVE PREVIOUSLY PRIOR TO THE IMPELLA WITH RHINOCIRUS/ENTEROVIRUS 11/29/23 AND WAS TREATED WITH ANTIBIOTICS. PATIENT WAS MONITORED FOR BREATHING THROUGHOUT (ALSO HAD HX OF PE). PATIENT INTUBATED ON (B)(6) 24 OR FOR IMPELLA PLACEMENT AND WAS EXTUBATED 1/4/24 1600. PATIENT WAS INTUBATED AGAIN 1/20/24 UNTIL 1/22/24.¿ ADDITIONALLY, THE PATIENT ENDURED PROGRESSION OF VENTRICULAR TACHYCARDIA WITH A "POSSIBLE" RELATIONSHIP TO THE IMPELLA DEVICE USED: ¿PATIENT HAD VT RUN PRIOR TO ADMISSION ON SITE FROM OSH. AFTER PATIENT WAS STARTED ON AMIODARONE, PATIENT DID NOT HAVE ANY VT SINCE (EP FOLLOWING). AFTER IMPELLA IMPLANT, PATIENT WAS CARDIOVERTED FOR VT AND CARDIOVERTED AGAIN 1/2/24 FOR SECOND RUN OF VT AND WAS STARTED ON AMIODARONE DRIP AND BOLUS. 1/8/24 FOR VT 200 HR. CARDIOVERTED AND LIDOCAINE STARTED.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401982 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2024407776 00813502011876

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Male Required Intervention| L