BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN SMART CONTROL SELF EXPANDING STENT

    MDR report key: 12246205 · Received July 29, 2021

    Report

    Report Number
    9616099-2021-04741
    Event Type
    Malfunction
    Date Received
    July 29, 2021
    Date of Event
    December 22, 2020
    Report Date
    July 29, 2021
    Manufacturer
    CARDINAL HEALTH MEXICO
    Product Code
    FGE
    PMA / PMN Number
    K021898
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: RIVAROXABAN (20 MG, QD) WAS TAKEN BY ALL PATIENTS FOR 3 MONTHS AFTER STENTING, AFTER WHICH PATIENTS TOOK RIVAROXABAN (10 MG, QD) FOR 1 YEAR AFTER SURGERY. 12 TO 14 MM, BOSTON SCIENTIFIC CORPORATION, USA. THIS COMPLAINT WAS IDENTIFIED DURING A RECENT CLINICAL EVALUATION REVIEW/LITERATURE SEARCH OF THIS DEVICE. THE DEVICE REMAINS IMPLANTED AND IS NOT AVAILABLE FOR EVALUATION. A COPY OF THE PUBLICATION IS ATTACHED TO THIS REPORT. THE CITATION IS AS FOLLOWS: YANG, Y., ZHAO, Y., CHEN, Z., WANG, Z., WANG, X., LI, F., & LIU, H. (2021). THE EFFECT OF STENT COMPRESSION ON IN-STENT RESTENOSIS AND CLINICAL OUTCOMES IN ILIAC VEIN COMPRESSION SYNDROME. QUANTITATIVE IMAGING IN MEDICINE AND SURGERY, 11(6), 2245¿2252. HTTPS://DOI.ORG/10.21037/QIMS-20-915, AS REPORTED IN THE LITERATURE ARTICLE BY YANG, Y., ZHAO, Y., CHEN, Z., WANG, Z., WANG, X., LI, F., & LIU, H. (2021). THE EFFECT OF STENT COMPRESSION ON IN-STENT RESTENOSIS AND CLINICAL OUTCOMES IN ILIAC VEIN COMPRESSION SYNDROME. QUANTITATIVE IMAGING IN MEDICINE AND SURGERY, 11(6), 2245¿2252. HTTPS://DOI.ORG/10.21037/QIMS-20-915, AFTER PLACEMENT OF AN UNKNOWN SMARTCONTROL STENT IN THE ILIAC VEIN, ONE PATIENT DEVELOPED STENT COMPRESSION. THE STENT WAS COMPRESSED LESS THAN 50% AND THE FILLING DEFECTS CAN BE OBSERVED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE REMAINS IMPLANTED IN THE PATIENT; THEREFORE, THEY ARE NOT AVAILABLE FOR ANALYSIS. A PRODUCT HISTORY RECORD (PHR) REVIEW COULD NOT BE CONDUCTED AS A LOT NUMBER WAS NOT PROVIDED. THE REPORTED ¿STENT-SES~ COMPRESSES/CRUSHED - IN PATIENT¿ WAS NOT CONFIRMED AS THE DEVICE REMAINS IMPLANTED INSIDE OF THE PATIENT. STENT COMPRESSION IS A RESULT OF CRUSHING OR FLATTENING OF THE DIAMETER OF THE STENT. IN THIS CASE, THIS OCCURRED EITHER DURING STENT IMPLANTATION BY THE MEDICAL PROVIDER OR, THE STENT WAS COMPRESSED BY AN EXTERNAL FORCE SUCH AS A HISTORY OF PERIPHERAL VASCULAR DISEASE (PVD). IN-STENT RESTENOSIS (ISR), WHICH IS COMMONLY ASSOCIATED WITH THE PROGRESSION OF PERIPHERAL VASCULAR DISEASE (PVD), IS A WELL-KNOWN POTENTIAL ADVERSE EVENT FOLLOWING STENT IMPLANTATION AND DOES NOT REPRESENT A DEVICE FAILURE. PROGRESSION OF ATHEROSCLEROSIS IS AN EXPECTED OUTCOME OF THE DISEASE PROCESS IF NOT TREATED APPROPRIATELY. 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. THEREFORE, 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. DURING PLACEMENT, IT IS IMPERATIVE THAT THE TREATING PHYSICIAN HOLDS THE DEPLOYMENT HANDLE IN A FIXED POSITION DURING THE ENTIRE DEPLOYMENT. IF THE HANDLE IS MOVED FORWARD OR BACKWARD AFTER THE STENT HAS ACHIEVED INITIAL WALL APPOSITION, THEN SEGMENTS OF COMPRESSION OR EXPANSION CAN BE CREATED. THIS CAN RESULT IN STENT LENGTHS WHICH ARE LONGER OR SHORTER THAN EXPECTED. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) ¿NOTE: FAILURE TO MAINTAIN A FIXED HANDLE POSITION OR CONSTRAINING THE CATHETER SHAFT DURING DEPLOYMENT MAY RESULT IN STENT COMPRESSION (SHORTENING) OR ELONGATION.¿ IT IS POSSIBLE THAT THE OPERATOR'S INTERACTION WITH THE STENT DELIVERY SYSTEM MAY HAVE CONTRIBUTED TO THE REPORTED EVENT IF THESE STEPS WERE NOT FOLLOWED CORRECTLY. BASED ON THE LIMITED INFORMATION AVAILABLE FOR REVIEW, IT IS NOT POSSIBLE TO DETERMINE WHAT FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. HOWEVER, PATIENT FACTORS AND THE USER¿S INTERACTION WITH THE DEVICE MAY HAVE LED TO THE REPORTED EVENT. WITHOUT A LOT NUMBER TO CONDUCT A PHR REVIEW, IT IS NOT POSSIBLE TO DETERMINE IF THE REPORTED EVENT COULD BE RELATED TO THE MANUFACTURING PROCESS. HOWEVER, AS THERE IS NO INDICATION THAT THE EVENT WAS RELATED TO A DESIGN OR MANUFACTURING ISSUE; NO CORRECTIVE OR PREVENTATIVE ACTIONS WILL BE TAKEN AT THIS TIME STENT-SES~ COMPRESSES/CRUSHED - IN PATIENT.

    Description of Event or Problem · 1

    AS REPORTED IN THE LITERATURE ARTICLE BY YANG, Y., ZHAO, Y., CHEN, Z., WANG, Z., WANG, X., LI, F., & LIU, H. (2021). THE EFFECT OF STENT COMPRESSION ON IN-STENT RESTENOSIS AND CLINICAL OUTCOMES IN ILIAC VEIN COMPRESSION SYNDROME. QUANTITATIVE IMAGING IN MEDICINE AND SURGERY, 11(6), 2245¿2252. HTTPS://DOI.ORG/10.21037/QIMS-20-915, AFTER PLACEMENT OF AN UNKNOWN SMARTCONTROL STENT IN THE ILIAC VEIN, ONE PATIENT DEVELOPED STENT COMPRESSION. THE STENT WAS COMPRESSED LESS THAN 50% AND THE FILLING DEFECTS CAN BE OBSERVED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1144052 UNKNOWN SMART CONTROL SELF EXPANDING STENT CATHETER, BILIARY, DIAGNOSTIC FGE CARDINAL HEALTH MEXICO N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 45