BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRASTENT LD

    MDR report key: 6151051 · Received December 7, 2016

    Report

    Report Number
    2183870-2016-00701
    Event Type
    Injury
    Date Received
    December 7, 2016
    Date of Event
    January 1, 2013
    Report Date
    November 8, 2016
    Manufacturer
    COVIDIEN
    Product Code
    FGE
    PMA / PMN Number
    K020528
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DAY AND MONTH ARE ESTIMATES. ARCHIVES OF CARDIOVASCULAR DISEASE (2015) 108, 650¿660 HTTP://DX.DOI.ORG/10.1016/J.ACVD.2015.07.002 1875-2136/© 2015 PUBLISHED BY ELSEVIER MASSON SAS. CORRESPONDING AUTHOR AT: CARDIOLOGIE PÉDIATRIQUE, HÔPITAL DES ENFANTS, CHU DE TOULOUSE, 330, AVENUE DE GRANDE-BRETAGNE, TSA 70034,31059 TOULOUSE CEDEX 9, FRANCE. E-MAIL ADDRESSES: [email protected], [email protected] (S. HASCOËT). A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    BACKGROUND ¿ MANY STENTS ARE USED ¿¿OFF-LABEL¿¿ DURING THE MANAGEMENT OF CONGENITAL HEART DISEASES (CHD). AIMS ¿ TO DESCRIBE INDICATIONS FOR, RESULTS OF, AND ADVERSE EVENTS ASSOCIATED WITH STENTING IN CHD IN CURRENT PRACTICE. METHODS ¿ PARTICIPATION IN THIS STUDY WAS PROPOSED TO ALL CATHETERIZATION LABORATORIES THAT SPECIALIZE IN CHD IN FRANCE (M3C NETWORK). ALL PAEDIATRIC AND ADULT CHD CASES WITH STENT IMPLANTATION IN 2013 WERE INCLUDED RETROSPECTIVELY. RESULTS ¿ OVERALL, 207 STENTS WERE IMPLANTED IN 151 PATIENTS ACROSS 11 CENTRES. MEDIAN AGE WAS 13.7 YEARS (RANGE, 5 DAYS TO 70.1 YEARS). MAIN PROCEDURE INDICATIONS WERE BRANCH PULMONARY ARTERY ANGIOPLASTY (N = 46, 29.1%), AORTIC (RE)COARCTATION STENTING (N = 43, 27.2%), PERCUTANEOUS PULMONARY VALVE IMPLANTATION (N = 32, 20.2%) AND DUCTUS ARTERIOSUS STENTING (N = 14, 8.9%). THE MAIN STENTS IMPLANTED WERE THE CP STENT ¿(N = 61, 29.5%), THE MAX¿ LD STENT (N = 43, 20.8%),THE VALEO®STENT (N = 28, 13.5%) AND VALVED STENTS (N = 30, 14.5%). PROCEDURES WERE CONSIDERED SUCCESSFUL IN 96.8% OF CASES (95% CONFIDENCE INTERVAL [CI] 92.8¿99.0%). ADVERSE EVENTS WERE OBSERVED IN 23 PROCEDURES (14.7%, 95% CI 9.5¿21.0%). A STROKE OCCURRED IN 2 PATIENTS WHERE THE MAX¿LD STENT WAS USED. CONCLUSIONS ¿ STENTS ARE USED IN VARIOUS CHD CATHETERIZATION PROCEDURES, FROM INFANCY TO ADULT AGE. THE ADVERSE EVENTS RATE IS SIGNIFICANT AND IS RELATED TO THE TYPE OF PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803397 INTRASTENT LD CATHETER, BILIARY, DIAGNOSTIC FGE COVIDIEN UNK-PLY-INTRA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention