BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA RP

    MDR report key: 7421463 · Received April 11, 2018

    Report

    Report Number
    1220648-2018-00020
    Event Type
    Injury
    Date Received
    April 11, 2018
    Date of Event
    March 15, 2018
    Report Date
    March 16, 2018
    Manufacturer
    ABIOMED, INC.
    Product Code
    OJE
    UDI-DI
    00813502010022
    PMA / PMN Number
    P170011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO KNOWN MALFUNCTION THAT WE ARE AWARE OF, HOWEVER NEITHER THE PUMP NOR THE INTRODUCER WAS RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    AN IMPELLA RP WAS PLACED FOR SUPPORT FOR RIGHT VENTRICULAR FAILURE, POST-PULMONARY EMBOLISM AND PULMONARY HYPERTENSION ON (B)(6). WHILE THE CLINICAL TEAM WAS REMOVING THE 23 X 30 PEEL AWAY SHEATH, A MATTRESS SUTURE WAS PLACED; HOWEVER IT WAS NOT SUFFICIENT TO MAINTAIN HEMOSTASIS. A SECOND MATTRESS WAS PLACED AND FEMOSTOP WAS APPLIED. UPON ARRIVAL TO CVICU, THERE WAS STILL CONTINUOUS BLEEDING FROM THE RIGHT FEMORAL VEIN. THE PATIENT WAS BROUGHT TO THE OPERATING ROOM FOR REPAIR OF THE VASCULATURE AND REMOVAL OF THE IMPELLA RP. THE PATIENT WAS THEN RETURNED TO THE CVICU WHERE SHE CONTINUED TO BLEED, REQUIRING THE ADMINISTRATION OF A BLOOD TRANSFUSION. THE PATIENT WENT INTO PULSELESS ELECTRICAL ACTIVITY (PEA) AND ARRESTED. CPR WAS PERFORMED HOWEVER THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264535 IMPELLA RP RIGHT VENTRICULAR BYPASS (ASSIST) DEVICE OJE ABIOMED, INC. IMPELLA RP 1311325 00813502010022

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Death| L| R| S