BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA RP

    MDR report key: 20219928 · Received September 14, 2024

    Report

    Report Number
    1220648-2024-17849
    Event Type
    Injury
    Date Received
    September 14, 2024
    Date of Event
    April 21, 2021
    Report Date
    September 14, 2024
    Manufacturer
    ABIOMED. INC.
    Product Code
    PYX
    UDI-DI
    00813502011029
    PMA / PMN Number
    P170011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER, THEREFORE, INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED. INSTRUCTIONS FOR USE FOR THE RELATED EVENT ARE AS FOLLOWS: IMPELLA RP WITH SMART ASSIST SYSTEM WITH AUTOMATED IMPELLA CONTROLLER SECTION: WARNINGS AND CAUTIONS ¿MAKE SURE THERE IS NO BLEEDING AT THE TRANSITION FROM THE REPOSITIONING SHEATH TO THE INTERNAL JUGULAR VEIN. CLOSE AND DRESS THE WOUND ¿BE SURE THAT THE STOPCOCK ON THE REPOSITIONING SHEATH IS ALWAYS KEPT IN THE CLOSED POSITION. SIGNIFICANT BLEED BACK CAN RESULT IF THE STOPCOCK IS OPEN.¿. ¿MAKE SURE THERE IS NO BLEEDING AT THE TRANSITION FROM THE REPOSITIONING SHEATH TO THE FEMORAL VEIN. CLOSE AND DRESS THE WOUND.¿. THIS REPORT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF HISTORICAL RECORDS.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED A PATIENT WITH POST CARDIOTOMY CARDIOGENIC SHOCK / LOW CARDIAC OUTPUT SYNDROME WAS IMPLANTED WITH AN IMPELLA RP FOR MECHANICAL CIRCULATORY SUPPORT. DURING SUPPORT, THE PATIENT EXPERIENCED BLEEDING AT THE ACCESS SITE. IT WAS REPORTED THAT THE STAFF ADDED HEPARIN TO THE PURGE AND APPLIED A MATTRESS SUTURE. ADDITIONALLY, AFTER PLACING A CENTRAL LINE THE PATIENT'S READING JUMPED TO 113/109. TROUBLE SHOOTING WAS CONDUCTED, AND IT WAS DETERMINED THAT THE CAUSE MIGHT BE A CLOT INGESTION DURING THE LINE EXCHANGE. THE PHYSICIAN DECIDED TO EXPLANT THE DEVICE. IT WAS REPORTED THAT THE PATIENT SURVIVED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1114312 IMPELLA RP TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP PYX ABIOMED. INC. IMPELLA RP 2022038665 00813502011029

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Required Intervention