BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICAST COVERED STENT

    MDR report key: 9767350 · Received February 27, 2020

    Report

    Report Number
    3011175548-2020-00337
    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 ADVERSE EVENTS INCLUDED OCCLUSION, STENT DISLODGEMENT, PULMONARY EDEMA, HEMORRHAGE AT ACCESS SITE, ARRHYTHMIA AND AIR EMBOLUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230114 ICAST COVERED STENT PROSTHESIS, TRACHEAL, EXPANDABLE JCT ATRIUM MEDICAL CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention