BEUDAMED
    FDA Adverse Event Death Summary report: N

    LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET

    MDR report key: 12092786 · Received June 30, 2021

    Report

    Report Number
    2522007-2021-00021
    Event Type
    Death
    Date Received
    June 30, 2021
    Date of Event
    May 6, 2021
    Report Date
    February 23, 2022
    Manufacturer
    COOK VANDERGRIFT INC
    Product Code
    DRE
    UDI-DI
    10827002237374
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT CODE: DRE. PMA/510(K): K141148.

    Description of Event or Problem · 1

    THE LITERATURE REPORT SPECIFIES TWO DEATHS IN A RETROSPECTIVE STUDY IN PATIENTS RECOMMENDED FOR CIED (CARDIOVASCULAR IMPLANTABLE ELECTRONIC DEVICE) REMOVAL FROM JANUARY 2012 TO JUNE 2018. ALL PROCEDURES WERE PERFORMED BY THE SAME CARDIAC SURGEON. SIMPLE RETRACTION WAS ATTEMPTED FIRST AND, IF NOT SUCCESSFUL, THE EVOLUTION OR THE EVOLUTION RL MECHANICAL SHEATHS BY COOK MEDICAL WERE USED. TWO PATIENTS DIED DUE TO RIGHT ATRIUM AND SUPERIOR VENA CAVA TEARS DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    990914 LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET DRE COOK VANDERGRIFT INC G23737 N148412 10827002237374

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death