BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART 120 150, SFA - 7X150MM

    MDR report key: 6087653 · Received November 8, 2016

    Report

    Report Number
    9616099-2016-00711
    Event Type
    Injury
    Date Received
    November 8, 2016
    Date of Event
    May 11, 2016
    Report Date
    January 19, 2017
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    UDI-DI
    20705032063439
    PMA / PMN Number
    K042969
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THESE LOTS OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT HAD IN-STENT RE-STENOSIS WITH TWO SMART STENTS AND A SMART CONTROL STENT. PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS PERFORMED FOR THE EDGES OF THE LESION, INSIDE THE IN-STENT RE-STENOSIS, AND WHOLE LESION. THE PATIENT RECOVERED. TWO SMART STENTS AND A SMART CONTROL STENT WERE PLACED IN THE TARGET LESION WITHOUT ANY ISSUE ON (B)(6) 2013. THREE YEARS LATER ((B)(6) 2016), INTERMITTENT CLAUDICATION WAS CONFIRMED ON THE PATIENT. THE PATIENT HAD AN ANGIOGRAPHY EXAMINATION ON (B)(6) 2016, AND PPI WAS PERFORMED. THE RATE OF ABI BEFORE PPI WAS 0.96 IN THE RIGHT AND 0.48 IN THE LEFT. THE RATE OF STENOSIS BEFORE PPI WAS 50 TO 99 % OF STENOSIS. THE TARGET LESION WAS THE DISTAL, MIDDLE, AND PROXIMAL PORTIONS OF THE LEFT SUPERFICIAL FEMORAL ARTERY. THE LESION WAS MODERATELY CALCIFIED AND NOT TORTUOUS. THE RATE OF STENOSIS WAS 100%. (B)(4). (B)(4): THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. MANUFACTURING RECORD (DHR) REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE PER THE APPLICABLE MANUFACTURING QUALITY PLAN. (B)(4): THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. MANUFACTURING RECORD (DHR) REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE PER THE APPLICABLE MANUFACTURING QUALITY PLAN. (B)(4): THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. MANUFACTURING RECORD (DHR) REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE PER THE APPLICABLE MANUFACTURING QUALITY PLAN. BASED ON THE LIMITED INFORMATION PROVIDED, IT IS NOT POSSIBLE TO DRAW A CONCLUSION ABOUT A CLINICAL RELATIONSHIP BETWEEN THE DEVICE AND THE EVENT. WITHOUT THE RETURN OF THE DEVICE FOR ANALYSIS, THE REPORTED CUSTOMER COMPLAINT COULD NOT BE CONFIRMED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. 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. VESSEL OCCLUSION, RESTENOSIS, INTIMAL HYPERPLASIA OR RECURRENT STRICTURES ARE WELL KNOWN DOCUMENTED POTENTIAL COMPLICATIONS OF THIS TYPE OF PROCEDURE AND ARE LISTED IN THE IFU AS SUCH. IN THE LITERATURE, 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. ISR IS MORE PREVALENT IN OSTIAL STENT PLACEMENT PROCEDURES. STENOSIS 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 LIMITED INFORMATION PROVIDED, IT IS NOT POSSIBLE TO DRAW A CONCLUSION ABOUT A CLINICAL RELATIONSHIP BETWEEN THE DEVICE AND THE EVENT. HOWEVER, NEITHER THE DHR REVIEW NOR THE PRODUCT ANALYSIS RESULTS SUGGESTS THAT THE REPORTED FAILURES COULD BE RELATED TO THE MANUFACTURING PROCESS OF THE UNIT. THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE TAKEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD IN-STENT RE-STENOSIS WITH TWO SMART STENTS AND A SMART CONTROL STENT. PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS PERFORMED FOR THE EDGES OF THE LESION, INSIDE THE IN-STENT RE-STENOSIS, AND WHOLE LESION. THE PATIENT RECOVERED. TWO SMART STENTS AND A SMART CONTROL STENT WERE PLACED IN THE TARGET LESION WITHOUT ANY ISSUE ON (B)(6) 2013. THREE YEARS LATER ((B)(6) 2016), INTERMITTENT CLAUDICATION WAS CONFIRMED ON THE PATIENT. THE PATIENT HAD AN ANGIOGRAPHY EXAMINATION ON (B)(6) 2016, AND PPI WAS PERFORMED. THE RATE OF ABI BEFORE PPI WAS 0.96 IN THE RIGHT AND 0.48 IN THE LEFT. THE RATE OF STENOSIS BEFORE PPI WAS 50 TO 99 % OF STENOSIS. THE TARGET LESION WAS THE DISTAL, MIDDLE, AND PROXIMAL PORTIONS OF THE LEFT SUPERFICIAL FEMORAL ARTERY. THE LESION WAS MODERATELY CALCIFIED AND NOT TORTUOUS. THE RATE OF STENOSIS WAS 100%. THIS IS A CASE FROM (B)(6) SMART PMS FOR SFA AND THE CASE NUMBER IS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737182 SMART 120 150, SFA - 7X150MM CATHETER, BILIARY, DIAGNOSTIC FGE CORDIS DE MEXICO C07150ML 15849814 20705032063439

    Patients

    Seq Age Sex Outcome Treatment
    1