BEUDAMED
    FDA Adverse Event Death Summary report: N

    ABIOMED IMPELLA RP

    MDR report key: 11900443 · Received May 27, 2021

    Report

    Report Number
    MW5101587
    Event Type
    Death
    Date Received
    May 27, 2021
    Date of Event
    May 6, 2021
    Report Date
    May 25, 2021
    Manufacturer
    ABIOMED INC.
    Product Code
    OJE
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS DIAGNOSED WITH MULTI-VESSEL CORONARY ARTERY DISEASE AND WAS REFERRED FOR CABG SURGERY. PATIENT WAS DECLINING AND SURGEON REQUESTED IMPELLA AND IMPELLA RP (RT HEART) BE PLACED PRIOR TO SURGERY. DEVICES WERE PLACED, BUT THERE WAS DIFFICULTY PLACING THE CATHETER FOR THE IMPELLA RP DUE TO PATIENT'S ANATOMY. DURING INSERTION THE CATHETER BROKE. ANOTHER CATHETER WAS SUCCESSFULLY PLACED, BUT THE PATIENT CONTINUED TO DECLINE AND EXPIRED IN THE CATH LAB. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795032 ABIOMED IMPELLA RP RIGHT VENTRICULAR BYPASS (ASSIST) DEVICE OJE ABIOMED INC. 004334

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death