BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART 120 150, SFA - 7X150MM

    MDR report key: 5993860 · Received October 3, 2016

    Report

    Report Number
    9616099-2016-00630
    Event Type
    Injury
    Date Received
    October 3, 2016
    Date of Event
    December 31, 2015
    Report Date
    October 3, 2016
    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

    AS REPORTED, THE PATIENT WAS ENROLLED IN A CLINICAL STUDY (B)(4) SMART PMS FOR SFA AND THE CASE NUMBER IS (B)(6).  APPROXIMATELY THIRTY MONTHS ((B)(6) 2015) POST STENTING OF THE MIDDLE PORTION OF THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) WITH A SMART STENT (120 150, SFA - 7X150MM) THROMBUS OCCURRED ON THE EDGE AND INSIDE OF THE SMART STENT.  THROMBECTOMY WAS PERFORMED FOR THE ACUTE ARTERIAL OCCLUSION OF THE LEFT LOWER EXTREMITY.  THEN ON (B)(6) 2016, AN OCCLUSION WAS CONFIRMED IN THE LEFT SUPERFICIAL FEMORAL ARTERY. HOWEVER THE OCCLUSION WAS NOT TREATED BECAUSE THE PATIENT HAD AN OPERATION OF GASTRIC CANCER. NO FURTHER TREATMENT PLAN HAS BEEN MADE.  AS OF (B)(6) 2016, THE PATIENT HAS NOT RECOVERED.  AT THE TIME OF THE INDEX PROCEDURE, THE SMART STENT WAS PLACED IN THE TARGET LESION WITHOUT ANY ISSUE. THE TARGET LESION WAS MILDLY CALCIFIED AND NOT TORTUOUS. THE RATE OF STENOSIS WAS 100%.  THE PRODUCT REMAINS IMPLANTED THEREFORE IT IS NOT AVAILABLE FOR ANALYSIS. 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 15851699 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. EIGHT (8) UNITS WERE REJECTED DURING THE FINAL ASSEMBLY OF THIS LOT. THROMBOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH STENT IMPLANTATION PROCEDURES AND IS LISTED IN THE IFU AS SUCH. THE ACT OF STENT IMPLANTATION PRODUCES INTENDED DAMAGE TO THE INTIMA OF THE VESSEL WALL IN ORDER TO REMODEL THE WALL AND REESTABLISH PATENCY OF THE VESSEL. THE DISRUPTION OF THE INTIMAL LAYERS TRIGGERS THE IMMUNE SYSTEM TO HEAL THE DAMAGED AREAS, THUS ACTIVATING THE CLOTTING MECHANISM AS WELL AS THE INFLAMMATORY RESPONSE. THE COMBINATION OF INFLAMMATORY RESPONSE AND CLOTTING CASCADE CAN LEAD TO THROMBUS FORMATION IN SIDE OF THE STENT AROUND THE DAMAGED AREAS. ALTHOUGH BASED ON THE AVAILABLE INFORMATION NO DEFINITIVE CONCLUSION CAN BE MADE, IT IS POSSIBLE THAT PATIENT, PROCEDURAL, AND PHARMACOLOGICAL FACTORS INCLUDING RESPONSIVENESS TO ANTIPLATELET THERAPY AND ANTICOAGULATION MAY HAVE CONTRIBUTED.

    Description of Event or Problem · 1

    AS REPORTED, THE PATIENT WAS ENROLLED IN A CLINICAL STUDY (B)(4) SMART PMS FOR SFA AND THE CASE NUMBER IS (B)(6). APPROXIMATELY THIRTY MONTHS ((B)(6) 2015) POST STENTING OF THE MIDDLE PORTION OF THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) WITH A SMART STENT (120 150, SFA - 7X150MM) THROMBUS OCCURRED ON THE EDGE AND INSIDE OF THE SMART STENT. THROMBECTOMY WAS PERFORMED FOR THE ACUTE ARTERIAL OCCLUSION OF THE LEFT LOWER EXTREMITY. THEN ON (B)(6) 2016, AN OCCLUSION WAS CONFIRMED IN THE LEFT SUPERFICIAL FEMORAL ARTERY. HOWEVER, THE OCCLUSION WAS NOT TREATED BECAUSE THE PATIENT HAD AN OPERATION OF GASTRIC CANCER. NO FURTHER TREATMENT PLAN HAS BEEN MADE. AS OF (B)(6) 2016, THE PATIENT HAS NOT RECOVERED. AT THE TIME OF THE INDEX PROCEDURE, THE SMART STENT WAS PLACED IN THE TARGET LESION WITHOUT ANY ISSUE. THE TARGET LESION WAS MILDLY CALCIFIED AND NOT TORTUOUS. THE RATE OF STENOSIS WAS 100%. THE PRODUCT REMAINS IMPLANTED THEREFORE IT IS NOT AVAILABLE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646977 SMART 120 150, SFA - 7X150MM CATHETER, BILIARY, DIAGNOSTIC FGE CORDIS DE MEXICO C07150ML 15851699

    Patients

    Seq Age Sex Outcome Treatment
    1 74 Required Intervention