BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRASTENT MAX LD

    MDR report key: 8423916 · Received March 15, 2019

    Report

    Report Number
    2183870-2019-00134
    Event Type
    Malfunction
    Date Received
    March 15, 2019
    Date of Event
    December 25, 2018
    Report Date
    March 15, 2019
    Manufacturer
    COVIDIEN
    Product Code
    FGE
    PMA / PMN Number
    K020528
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE OR DATE OF BIRTH: AVERAGE AGE. SEX: MAJORITY GENDER. DATE OF EVENT: DATE OF PUBLICATION. JOURNAL ARTICLE TITLE: "PREDICTIVE FACTORS FOR RESIDUAL HYPERTENSION FOLLOWING AORTIC COARCTATION STENTING." J CLIN HYPERTENS. 2019; 21: 291¿298. WILEYONLINELIBRARY.COM/JOURNAL/JCH ©2018 WILEY PERIODICALS, INC., 291 XAVIER IRIART. HTTPS://ORCID.ORG/0000-0002-4911-7432. RECEIVED: 8 JULY 2018, REVISED: 23 SEPTEMBER 2018, ACCEPTED: 5 OCTOBER 2018. DOI: 10.1111/JCH.13452. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE AIM OF THIS RETROSPECTIVE STUDY WAS TO IDENTIFY THE PREDICTIVE FACTORS FOR RESIDUAL HT IN PATIENTS WHO HAD UNDERGONE COA STENTING. THIRTY CONSECUTIVE PATIENTS WHO HAD UNDERGONE COA STENTING BETWEEN 2007 AND 2015 WERE INCLUDED IN THE STUDY. ALL PROCEDURES WERE PERFORMED BY A SINGLE EXPERIENCED OPERATOR. THE TECHNICAL PARAMETERS WERE RECORDED DURING THE PROCEDURE. THE OPTIMAL OUTCOME OF THE PROCEDURE WAS DEFINED AS A RESIDUAL GRADIENT OF 10MM HG. THE LENGTH OF THE STENT WAS CHOSEN IN ORDER TO NORMALIZE THE PRESSURE GRADIENT BETWEEN THE ASCENDING AND DESCENDING AORTA CAUSED BY VARIOUS ANOMALIES RANGING FROM FOCAL NARROWING OF THE ISTHMIC AREA (DISTAL TO THE LEFT SUBCLAVIAN ARTERY), TO DIFFUSE AORTIC ARCH HYPOPLASIA. AS CHILDREN AND ADULTS WERE INCLUDED IN THE STUDY AN INDEXED STENT LENGTH, CORRESPONDING TO THE LENGTH OF THE STENT IN MILLIMETRES DIVIDED BY THE PATIENT'S HEIGHT IN METERS, WAS CALCULATED FOR USE IN THE STATISTICAL ANALYSIS THE INDICATION FOR STENTING WAS NATIVE COA OR RECOA . THREE PATIENTS UNDERWENT TWO CATHETERIZATION PROCEDURES TO ACHIEVE A SATISFACTORY HEMODYNAMIC OUTCOME (TRANSAORTIC GRADIENT 10MM HG). MEDIAN STENT LENGTH EMPLOYED WAS 29 MM. OF THE STENTS USED IN THE PROCEDURES, 19 PATIENTS WERE TREATED WITH AN INTRASTENT MAX LD. TWO SERIOUS COMPLICATIONS LINKED TO THE CATHETERIZATION PROCEDURE WERE OBSERVED: MIGRATION OF THE STENT AND CEREBELLAR STROKE. FOURTEEN OF THE PATIENTS (46.7%) HAD HT AFTER STENTING, THREE OF WHOM WERE CHILDREN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219183 INTRASTENT MAX LD CATHETER, BILIARY, DIAGNOSTIC FGE COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR