BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 2241895 · Received September 9, 2011

    Report

    Report Number
    9616099-2011-00717
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    August 12, 2011
    Report Date
    August 17, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    K021898
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT. THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2011-00717, 9616099-2011-00718, AND 9616099-2011-00719. IT WAS UNKNOWN IF EXCESSIVE FORCE WAS USED DURING THE PROCEDURE. NO RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE DEVICE OR WHILE WITHDRAWING THE DEVICE. THE SEPARATED PIECE DID NOT MIGRATE AND REMAINS IN THE PATIENT. IT WAS UNKNOWN IF THE DEVICE KINKED IN THE AREA OF SEPARATION. THE EXACT LOT NUMBER FOR THE FRACTURED STENT WAS NOT CLEAR. THE PATIENT WAS TREATED WITH BYPASS PROCEDURE AND NO OTHER INJURY OCCURRED. NO PROCEDURAL CD OR FILMS ARE AVAILABLE FOR REVIEW.

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2011-00717, 9616099-2011-00718, AND 9616099-2011-00719. DUE TO ARTERIOSCLEROSIS IN HIS LEFT LOWER LIMB, THE PATIENT HAD THREE SMART CONTROL STENTS PLACED IN THE LEFT SUPERFICIAL FEMORAL ARTERY. THE 1ST STENT OVERLAPPED WITH THE 2ND STENT, BUT THE 2ND STENT DID NOT OVERLAP WITH THE 3RD STENT. THE PATIENT RETURNED WITH PAIN IN HIS LEFT LOWER LIMB, AGGRAVATED AT NIGHT. THE MAIN PAIN SITE WAS AT HIS LEFT ANKLE, IT WAS PAROXYSMAL REST PAIN, NO SWELLING OR INTERMITTENT CLAUDICATION. COLOR DOPPLER ULTRASOUND WAS PERFORMED AND REVEALED LEFT LOWER LIMB HAD ARTERIOSCLEROSIS AND OCCLUSION. THE STENT IMPLANTED IN HIS LEFT SUPERFICIAL FEMORAL ARTERY (SFA) HAD AN IN-STENT THROMBOSIS OCCLUSION. CT SCAN WAS PERFORMED WHICH REVEALED THAT THE 1ST STENT WAS FRACTURED AND HAD SEPARATED. THE SEPARATED PIECE DID NOT MIGRATE AND REMAINS IN THE PATIENT. THE EXACT LOT NUMBER FOR THE FRACTURED STENT WAS NOT CLEAR. THE PATIENT WAS TREATED WITH BY-PASS AND WAS LISTED IN STABLE CONDITION. THE PRE-PROCEDURE STENOSIS PERCENTAGE WAS DESCRIBED AS COLOR DOPPLER ULTRASOUND REVEALING LEFT LOWER LIMB WITH ARTERIOSCLEROSIS AND OCCLUSION. RESIDUAL STENOSIS WAS 0%. THE LESION WAS DESCRIBED AS 25CM IN LENGTH, CHRONIC TOTAL OCCLUSION, CONCENTRIC WITH UNKNOWN CALCIFICATION. THE REFERENCE VESSEL WAS NON-TORTUOUS. AN UNKNOWN 4MMX120MM BALLOON CATHETER WAS USED TO PRE-DILATE THE LEFT SFA AND AN UNKNOWN 3MMX120MM BALLOON CATHETER WAS USED TO PRE-DILATE THE POPLITEAL ARTERY, TIBIAL ARTERY, AND FIBULAR ARTERY. NO POST-DILATION WAS DONE. IT WAS UNKNOWN IF EXCESSIVE FORCE WAS USED DURING THE PROCEDURE. NO RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE DEVICE OR WHILE WITHDRAWING THE DEVICE. (B)(4): THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. 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. (B)(4): THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. 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. (B)(4): THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. 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. THERE ARE MULTIPLE FACTORS THAT CAN CONTRIBUTE TO STENT FRACTURE IN THE SFA. THE SFA IS A VERY DYNAMIC VESSEL THAT UNDERGOES BIOMECHANICAL FORCES SUCH AS FLEXION, TORSION, COMPRESSION, AND ELONGATION. STUDIES HAVE ALSO REVEALED THAT NITINOL STENT FRACTURES OCCURRED IN CASES OF MULTIPLE STENTS AND OVERLAP RELATED TO AN ABNORMAL STRESS AREA THAT IS CREATED. THE CUMULATIVE LENGTH OF THE STENTED SEGMENT UNEQUIVOCALLY HAS BEEN IDENTIFIED AS THE MOST IMPORTANT DETERMINANT FOR MATERIAL FATIGUE AND SUBSEQUENT FRACTURE. IN THIS CASE, VESSEL/LESION CHARACTERISTICS, PROCEDURAL FACTORS AND/OR BIOMECHANICAL FORCES LIKELY CONTRIBUTED TO THE REPORTED EVENT. THROMBOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH STENT IMPLANTATION PROCEDURES AND IS LISTED IN THE INSTRUCTIONS FOR USE (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 INSIDE OF THE STENT AROUND THE DAMAGED AREAS. SEVERAL FACTORS, INCLUDING MECHANICAL PLAQUE DISRUPTION, INTIMAL INJURY, AND STENT THROMBOGENICITY PREDISPOSE THE PATIENT TO THROMBOEMBOLIC EVENTS. PLATELET ADHESION, ACTIVATION, AND AGGREGATION PLAY MAIN ROLES IN MURAL THROMBUS FORMATION.

    Description of Event or Problem · 1

    STENT FRACTURED AND SEPARATED: THE PATIENT WAS TREATED WITH BALLOON DILATION AND STENTING DUE TO ARTERIOSCLEROSIS AT HIS LEFT LOWER LIMB ON (B)(6) 2010. THREE SMART CONTROL STENTS WERE IMPLANTED AT HIS LEFT SUPERFICIAL FEMORAL ARTERY (SFA) (LOT NO: 16096423 / 16091581 / 16095423). THE 1ST STENT OVERLAPPED WITH THE 2ND STENT, THE 2ND STENT DID NOT OVERLAP WITH THE 3RD STENT. AFTER THE PROCEDURE, THE PATIENT HAD ANTICOAGULANT MEDICATION TREATMENT. HALF A MONTH AGO, THE PATIENT HAD PAIN AT HIS LEFT LOWER LIMB, AGGRAVATED AT NIGHT. THE MAIN PAIN SITE WAS AT HIS LEFT ANKLE, IT WAS PAROXYSMAL REST PAIN, NO SWELLING OR INTERMITTENT CLAUDICATION. COLOR DOPPLER ULTRASOUND WAS PERFORMED AND REVEALED THAT LEFT LOWER LIMB HAD ARTERIOSCLEROSIS AND OCCLUSION. THE STENT IMPLANTED AT HIS LEFT SFA HAD IN-STENT THROMBOSIS OCCLUSION. HIS LEFT POPLITEAL ARTERY, ANTERIOR TIBIAL ARTERY AND POSTERIOR TIBIAL ARTERY WAS ISCHEMIC. CT WAS PERFORMED AND REVEALED THAT THE 1ST STENT WAS FRACTURED AND SEPARATED. NOW THE PATIENT WAS TREATED WITH BY-PASS PROCEDURE AND WAS IN STABLE CONDITION. THE EXACT LOT NUMBER FOR THE FRACTURED STENT WAS NOT CLEAR, SO WE PROVIDED TOTAL 3 LOT NUMBER THAT WERE IMPLANTED IN THE PATIENT. (16096423 / 16091581 / 16095423). THERE WAS NO DAMAGE NOTED WITH THE PACKAGING PRIOR TO USE. THE DEVICE WAS STORED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PRE-PROCEDURE STENOSIS PERCENTAGE WAS DESCRIBED AS COLOR DOPPLER ULTRASOUND REVEALING LEFT LOWER LIMB WITH ARTERIOSCLEROSIS AND OCCLUSION. RESIDUAL STENOSIS WAS 0%. THE LESION WAS DESCRIBED AS 25CM IN LENGTH, CHRONIC TOTAL OCCLUSION, CONCENTRIC WITH UNKNOWN CALCIFICATION. THE REFERENCE VESSEL WAS NON-TORTUOUS. AN UNKNOWN 4MMX120MM BALLOON CATHETER WAS USED PRE-DILATE THE LEFT SFA AND AN UNKNOWN 3MMX120MM BALLOON CATHETER WAS USED TO PRE-DILATE THE POPLITEAL ARTERY, TIBIAL ARTERY, AND FIBULAR ARTERY. NO POST-DILATION WAS DONE.

    Description of Event or Problem · 1

    TREATMENT FOR THE IN-STENT THROMBOSIS WAS THE BYPASS PROCEDURE. THE VESSEL TREATED WITH THE BYPASS PROCEDURE WAS THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) AND THE BYPASS PATH CAN COVER THE THREE STENTS' LENGTH. TREATMENT FOR THE ISCHEMIC LEFT POPLITEAL ARTERY, ANTERIOR TIBIAL ARTERY, AND POSTERIOR TIBIAL ARTERY WAS THE BYPASS PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R