BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 3973414 · Received August 1, 2014

    Report

    Report Number
    9616099-2014-00507
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 10, 2014
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    K042969
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: APPROXIMATELY 13 MONTHS AFTER HAVING A SMART STENT IMPLANTED IN THE SUPERFICIAL ARTERY THE PATIENT UNDERWENT REVASCULARIZATION BY BALLOON ANGIOPLASTY SECONDARY TO RESTENOSIS. THE PATIENT WAS TAKING ASPIRIN AND CLOPIDOGREL. THERE WAS NO REPORTED PATIENT INJURY. DEVICE HISTORY REVIEW SHOWED NO ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. 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. 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. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. BASED ON THE LACK OF INFORMATION AND THE INABILITY TO ASSIGN OR DETERMINE A ROOT CAUSE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED BY THE QUAL REP, RESTENOSIS WAS FOUND IN THE PLACED 6X150MM SMART STENT. THE SMART STENT WAS IMPLANTED ON (B)(6) 2013 WITH ANY PROBLEM IN THE SUPERFICIAL FEMORAL ARTERY. ON (B)(6) 2014, THE PATIENT UNDERWENT A REVASCULARIZATION BY POBA. THE PATIENT IS NOW IN GOOD CONDITION. THE PATIENT DID NOT PRESENT WITH ANY SYMPTOMS RELATING TO THE RESTENOSIS. THE PATIENT¿S MEDICAL HISTORY IS UNKNOWN. ONLY ONE STENT HAD BEEN PREVIOUSLY IMPLANTED IN THE AREA OF REVASCULARIZATION. THE PATIENT WAS ON COMPLAINT ON ASPIRIN AND CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451126 SMART CONTROL NITINOL STENT SYSTEM SELF EXPANDING STENTS (FGE) FGE CORDIS DE MEXICO 15845064

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Life Threatening| R