BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART CONTROL UNKNOWN

    MDR report key: 12293451 · Received August 9, 2021

    Report

    Report Number
    9616099-2021-04767
    Event Type
    Injury
    Date Received
    August 9, 2021
    Date of Event
    December 22, 2020
    Report Date
    August 9, 2021
    Manufacturer
    CORDIS CORPORATION
    Product Code
    FGE
    PMA / PMN Number
    K021898
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS FOUND DURING A RECENT CLINICAL EVALUATION REVIEW/LITERATURE SEARCH OF THIS DEVICE. 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. SPECIFIC PRODUCT DETAILS ARE NOT AVAILABLE. THE EXACT EVENT DATE IS UNKNOWN. THE PUBLICATION IS ATTACHED. COMPLAINT CONCLUSION: 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, ONE MONTH AFTER PLACEMENT OF AN UNKNOWN SMART CONTROL STENT IN THE ILIAC VEIN, 9 OUT OF 50 PATIENTS DEVELOPED IN STENT RESTENOSIS (ISR). THE DEVICE REMAINS IMPLANTED IN THE PATIENT; THEREFORE, NOT AVAILABLE FOR ANALYSIS. A PRODUCT HISTORY RECORD (PHR) REVIEW COULD NOT BE CONDUCTED AS A LOT NUMBER WAS NOT PROVIDED. THE REPORTED ¿IN-STENT VENOUS RESTENOSIS¿ COULD NOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS, NOR WERE PROCEDURAL IMAGES PROVIDED FOR REVIEW. THE EXACT CAUSE COULD NOT BE DETERMINED. HANDLING AND OR PROCEDURAL FACTORS SUCH AS VESSEL CHARACTERISTICS (ALTHOUGH UNKNOWN) AND THE PATIENT¿S MEDICAL HISTORY MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. 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. 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. 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. STENOSIS IN STENTS IS USUALLY TREATED WITH INTRASTENT PTA OR PLACEMENT OF A SECOND STENT. FACTORS THAT MAY HAVE INFLUENCED THIS EVENT INCLUDE PATIENT, PROCEDURAL, PHARMACOLOGICAL AND LESION. WITH THE LIMITED AMOUNT OF INFORMATION AVAILABLE AND WITHOUT THE RETURN OF THE PRODUCT FOR ANALYSIS OR FILMS OF THE EVENT IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND 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. ADDITIONALLY, THERE IS NO INDICATION THAT THE EVENT WAS RELATED TO A DESIGN OR MANUFACTURING ISSUE THEREFORE, NO CORRECTIVE AND PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    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, ONE MONTH AFTER PLACEMENT OF AN UNKNOWN SMARTCONTROL STENT IN THE ILIAC VEIN, 9 OUT OF 50 PATIENTS DEVELOPED INSTENT RESTENOSIS (ISR). THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1190733 SMART CONTROL UNKNOWN CATHETER, BILIARY, DIAGNOSTIC FGE CORDIS CORPORATION CXXXXXX UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening