BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 4180634 · Received October 17, 2014

    Report

    Report Number
    9616099-2014-00663
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    July 29, 2013
    Report Date
    November 18, 2014
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NIO
    PMA / PMN Number
    P020036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED ADVERSE EVENT AND ARE ASSOCIATED MANUFACTURER REPORT NUMBERS: 9616099-2014-00662 & 9616099-2014-00663. THIS DEVICE IS NOT AVAILABLE FOR TESTING AND EVALUATION. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED ADVERSE EVENT AND ARE ASSOCIATED MANUFACTURER REPORT NUMBERS: 9616099-2014-00662 & 9616099-2014-00663. COMPLAINT CONCLUSION: AS REPORTED BY THE (B)(4) STUDY, 50-99% RESTENOSIS WAS FOUND IN BOTH STUDY STENTS 53 DAYS POST INDEX PROCEDURE. THE LESION WAS TREATED BY PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) (POBA). THE PATIENT RECOVERED THE FOLLOWING DAY. THE (B)(6) MALE PATIENT WITH A HISTORY OF PERIPHERAL ARTERIAL DISEASE HAD TWO SMART CONTROL STENTS PLACED IN THE DISTAL PORTION OF THE RIGHT SUPERFICIAL FEMORAL ARTERY AT THE TIME OF THE INDEX PROCEDURE. THE RATE OF STENOSIS WAS 100%. THERE WAS GOOD WALL APPOSITION OF THE STENTS. THERE WAS NO INDICATION OF VESSEL DISSECTION. IT IS UNKNOWN IF THE STENTS WERE POST-DILATION. THERE WAS NO DISEASE DISTAL TO THE STENTS. THE PATIENT WAS COMPLIANT WITH ANTIPLATELET THERAPY. THERE WAS NO STENT THROMBOSIS REPORTED. THE PATIENT IS CURRENTLY IN STABLE CONDITION. THE COMPLAINT PRODUCT WAS NOT RETURNED FOR ANALYSIS AS THE DEVICE REMAINS IMPLANTED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THESE LOTS OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. IN-STENT RESTENOSIS (ISR) IS ASSOCIATED WITH THE PROGRESSION OF ATHEROSCLEROTIC DISEASE AND IS A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING STENT IMPLANTATION AND DOES NOT REPRESENT A DEVICE FAILURE. INTRA-ARTERIAL STENT PLACEMENT IS A TREATMENT OF THE DISEASE PROCESS, IT IS NOT A PREVENTIVE OR CURE FOR THE PROGRESSION OF SYMPTOMS OF ATHEROSCLEROTIC ARTERY DISEASE. IN-STENT STENOSIS RATES RANGE FROM 11% TO 39% FROM 6 TO 12 MONTHS AFTER STENT PLACEMENT. RATES WERE HIGHER IN OLDER PATIENTS WITH MORE SEVERE ATHEROSCLEROSIS AND DEPENDED ON THE TYPE OF STENOSIS TREATED. STENOSES IN STENTS ARE USUALLY TREATED WITH INTRASTENT PTA OR PLACEMENT OF A SECOND STENT. FACTORS THAT MAY HAVE INFLUENCED THIS EVENT INCLUDE PATIENT, PROCEDURAL, PHARMACOLOGICAL AND LESION. 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.

    Description of Event or Problem · 1

    AS REPORTED BY THE (B)(4) STUDY, 50-99% RESTENOSIS WAS FOUND IN BOTH STUDY STENTS 53 DAYS POST INDEX PROCEDURE. THE LESION WAS TREATED BY PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) (POBA). THE PATIENT RECOVERED THE FOLLOWING DAY. THE PATIENT HAD TWO SMART CONTROL STENTS PLACED IN THE DISTAL PORTION OF THE RIGHT SUPERFICIAL FEMORAL ARTERY AT THE TIME OF THE INDEX PROCEDURE. THE RATE OF STENOSIS WAS 100%. THERE WAS GOOD WALL APPOSITION OF THE STENTS. THERE WAS NO INDICATION OF VESSEL DISSECTION. IT IS UNKNOWN IF THE STENTS WERE POST-DILATION. THERE WAS NO DISEASE DISTAL TO THE STENTS. THE PATIENT WAS COMPLIANT WITH ANTIPLATELET THERAPY. THERE WAS NO STENT THROMBOSIS REPORTED. THE PATIENT IS CURRENTLY IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663216 SMART CONTROL NITINOL STENT SYSTEM SELF EXPANDING STENTS (NIO) NIO CORDIS CORPORATION C07040ML 15624207

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention SMART CONTROL, ASPIRIN AND CLOPIDOGREL