BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICAST COVERED STENT

    MDR report key: 9767355 · Received February 27, 2020

    Report

    Report Number
    3011175548-2020-00335
    Event Type
    Injury
    Date Received
    February 27, 2020
    Report Date
    February 27, 2020
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    JCT
    PMA / PMN Number
    K050814
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE INVESTIGATION WAS NOT ABLE TO BE PERFORMED AS NO PRODUCT CODE, LOT NUMBER OR SAMPLE WAS PROVIDED. PER THE STUDY, DRUG-ELUTING STENTS (DES) HAVE SIGNIFICANTLY LOWERED LUMEN LOSS RATE WHEN COMPARED TO BAREMETAL STENTS (BMS) AT MEDIUM TERM FOLLOW-UP AND CAN BE FRACTURED TO ENABLE LARGER DIAMETERS. AVAILABILITY OF LARGER DIAMETER DES WOULD BE IDEAL.

    Description of Event or Problem · 1

    RECEIVED AN ARTICLE TITLED: KHAN, A. E. (2019). COMPARISON OF DRUG ELUTING VERSUS BARE METAL STENTS FOR PULMONARY VEIN STENOSIS IN CHILDHOOD. CATHETER CARDIOVASCULAR INTERVENTIONS, PP. 233-242. PURPOSE: COMPARISON OF OUTCOMES USING BAREMETAL (BMS) AND DRUG-ELUTING (DES) STENTS IN PULMONARY VEIN STENOSIS (PVS). METHOD: A RETROSPECTIVE REVIEW OF ALL PATIENTS WHO UNDERWENT STENT IMPLANTATION BETWEEN 08/93 AND 11/17 FOR PVS AT TEXAS CHILDREN'S HOSPITAL WAS PERFORMED. PER THE ARTICLE DEATHS OCCURRED WITHIN THE STUDY PERIOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230171 ICAST COVERED STENT PROSTHESIS, TRACHEAL, EXPANDABLE JCT ATRIUM MEDICAL CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention