BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 4213388 · Received October 30, 2014

    Report

    Report Number
    9616099-2014-00699
    Event Type
    Injury
    Date Received
    October 30, 2014
    Date of Event
    December 3, 2013
    Report Date
    October 6, 2014
    Manufacturer
    CORDIS CORPORATION
    Product Code
    FGE
    PMA / PMN Number
    K042969
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE. PLEASE REFERENCE MFR. REPORT # 9616099-2014-00698 AND # 9616099-2014-00699.

    Additional Manufacturer Narrative · 1

    AS REPORTED, THE PATIENT WAS ENROLLED IN A (B)(4) STUDY (B)(4) SMART PMS FOR SFA AND THE CASE NUMBER IS (B)(4). THE PATIENT HAS TWO (2 EACH) STENTS IMPLANTED DURING THE STUDY INDEX PROCEDURE: A SMART CONTROL 7 X 100, AND A SMART 120/150 CM. SMART 7X 150 STENT. THE TARGET LESION WAS THE LEFT SUPERFICIAL FEMORAL ARTERY (LSFA). THE LESION WAS A 100% STENOSIS. RESTENOSIS WAS FOUND IN THE PLACED STENT-DATE UNKNOWN AND THE RATE OF STENOSIS WAS UNKNOWN. APPROXIMATELY SIX MONTHS AFTER THE STUDY INDEX PROCEDURE, THE RESTENOSIS WAS TREATED BY PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). THE PATIENT WAS REPORTED TO HAVE RECOVERED THE DAY AFTER THE PROCEDURE. THE TWO (2) STENTS WERE IMPLANTED IN OVERLAPPING FASHION. THE RESTENOSIS INVOLVED BOTH STENTS. THE EXACT DATE OF IMPLANTATION WAS UNKNOWN. THE PATIENT¿S MEDICAL HISTORY WAS UNKNOWN. THE PATIENT¿S MEDICAL REGIMEN POST-INDEX PROCEDURE WAS UNKNOWN DUAL ANTIPLATELET THERAPY. THE PATIENT WAS COMPLIANT WITH THE MEDICAL REGIMEN. NO ADDITIONAL INFORMATION IS AVAILABLE. THE DEVICES REMAIN IMPLANTED IN THE PATIENT AND ARE NOT AVAILABLE FOR INSPECTION. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 15849814 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. RESTENOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH IMPLANTING PERIPHERAL ARTERY STENTS AND IS OFTEN ASSOCIATED WITH THE PROGRESSION OF PERIPHERAL VASCULAR DISEASE. LESION FACTORS, A 100% STENOSIS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE AVAILABLE INFORMATION THERE IS NO EVIDENCE TO SUGGEST THAT THE EVENT WAS DESIGN OR MANUFACTURING RELATED THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE. PLEASE REFERENCE MFR. REPORT # 9616099-2014-00698 AND # 9616099-2014-00699.

    Description of Event or Problem · 1

    AS REPORTED, THE PATIENT WAS ENROLLED IN A (B)(4) STUDY AND THE CASE NUMBER IS (B)(4). THE PATIENT HAS TWO (2 EACH) STENTS IMPLANTED DURING THE STUDY INDEX PROCEDURE: A SMART CONTROL 7 X 100, AND A SMART 120/150 CM. SMART 7X 150 STENT. THE TARGET LESION WAS THE LEFT SUPERFICIAL FEMORAL ARTERY (LSFA). THE LESION WAS A 100% STENOSIS. RESTENOSIS WAS FOUND IN THE PLACED STENT-DATE UNKNOWN AND THE RATE OF STENOSIS WAS UNKNOWN. APPROXIMATELY SIX MONTHS AFTER THE STUDY INDEX PROCEDURE, THE RESTENOSIS WAS TREATED BY PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). THE PATIENT WAS REPORTED TO HAVE RECOVERED THE DAY AFTER THE PROCEDURE. THE TWO (2) STENTS WERE IMPLANTED IN OVERLAPPING FASHION. THE RESTENOSIS INVOLVED BOTH STENTS. THE EXACT DATE OF IMPLANTATION WAS UNKNOWN. THE PATIENT¿S MEDICAL HISTORY WAS UNKNOWN. THE PATIENT¿S MEDICAL REGIMEN POST-INDEX PROCEDURE WAS UNKNOWN DUAL ANTIPLATELET THERAPY. THE PATIENT WAS COMPLIANT WITH THE MEDICAL REGIMEN. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696071 SMART CONTROL NITINOL STENT SYSTEM SELF EXPANDING STENTS (FGE) FGE CORDIS CORPORATION C07150ML 15849814

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization| L| R