BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 2040204 · Received April 5, 2011

    Report

    Report Number
    9616099-2011-00223
    Event Type
    Injury
    Date Received
    April 5, 2011
    Date of Event
    December 13, 2010
    Report Date
    February 5, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    K021898
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED UPON 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    THE PATIENT FROM THE (B)(4) STUDY EXPERIENCED RESTENOSIS APPROXIMATELY ONE YEAR POST IMPLANTATION OF A CYPHER STENT. PAST MEDICAL HISTORY WAS UNKNOWN. TREATMENT OF A 70% ECCENTRIC, DE NOVO AND CALCIFIED LESION IN THE RIGHT TIBIOPERONEAL ARTERY WAS CONDUCTED DURING THE INDEX PROCEDURE. THE LESION WAS 15MM IN LENGTH. A 3.0 X 18MM CYPHER SELECT PLUS STENT IMPLANTED. APPROXIMATELY A MONTH POST INDEX PROCEDURE, THE PATIENT WAS NOTED TO HAVE STENOSIS IN THE LEFT SUPERFICIAL FEMORAL ARTERY, A NON-TARGET VESSEL. THE PATIENT WAS TREATED BY PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. APPROXIMATELY A YEAR POST INDEX PROCEDURE, THE PATIENT HAD A DIAGNOSTIC ANGIOGRAM PERFORMED. HIGH GRADE IN-STENT RESTENOSIS WAS OBSERVED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY; THIS LESION HAD BEEN PREVIOUSLY TREATED WITH A SMART STENT. HIGH GRADE, 90%, IN-STENT RESTENOSIS WAS OBSERVED IN THE RIGHT TIBIOPERONEAL TRUNK. ANGIOPLASTY OF THE RIGHT SUPERFICIAL FEMORAL ARTERY AND RIGHT TIBIOPERONEAL TRUNK WAS PERFORMED. THE PRODUCT REMAINS IMPLANTED IN THE PATIENT AND IS THUS NOT AVAILABLE FOR EVALUATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. RESTENOSIS IS A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING STENT IMPLANTATION AND IS OFTEN ASSOCIATED WITH THE PROGRESSION OF PERIPHERAL VASCULAR DISEASE. PATIENTS WHO ARE KNOWN TO BE AT HIGH-RISK FOR RESTENOSIS INCLUDE THOSE WITH DIABETES, LONG LESIONS, SMALL VESSELS, BIFURCATIONS, AND RESTENOTIC LESIONS. REVIEW OF THE INFORMATION PROVIDED SUGGESTS THAT THERE ARE POSSIBLE VESSEL/LESION FACTORS (CALCIFICATION) AND PROGRESSION OF DISEASE THAT MAY HAVE CONTRIBUTED TO THIS PATIENT'S RESTENOTIC EVENT. NEITHER THE DHR NOR THE INFORMATION AVAILABLE FOR REVIEW INDICATE THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE, THEREFORE NO CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE PATIENT WAS ENROLLED IN THE (B)(4) STUDY WITH A 70% ECCENTRIC, DE NOVO AND CALCIFIED LESION IN THE RIGHT TIBIOPERONEAL ARTERY. THE LESION WAS 15MM IN LENGTH. A 3.0 X 18MM CYPHER SELECT PLUS STENT IMPLANTED. APPROXIMATELY A YEAR POST INDEX PROCEDURE, THE PATIENT HAD A DIAGNOSTIC ANGIOGRAM PERFORMED. HIGH GRADE IN-STENT RESTENOSIS WAS OBSERVED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY; THIS LESION HAD BEEN PREVIOUSLY TREATED WITH A SMART STENT. HIGH GRADE, 90%, IN-STENT RESTENOSIS WAS OBSERVED IN THE RIGHT TIBIOPERONEAL TRUNK. ANGIOPLASTY OF THE RIGHT SUPERFICIAL FEMORAL ARTERY AND RIGHT TIBIOPERONEAL TRUNK WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMART CONTROL NITINOL STENT SYSTEM SELF EXPANDING STENTS (FGE) FGE CORDIS DE MEXICO NA 15023417

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention