BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 4181258 · Received October 17, 2014

    Report

    Report Number
    9616099-2014-00665
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    July 9, 2014
    Report Date
    September 24, 2014
    Manufacturer
    CORDIS CORPORATION
    Product Code
    FGE
    PMA / PMN Number
    K042969
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). AS REPORTED BY (B)(6), ON AN UNKNOWN DATE AFTER PLACEMENT OF 2 SMART CONTROL STENTS THE RIGHT SUPERFICIAL FEMORAL ARTERY, 50-99% RESTENOSIS WAS FOUND. THE LESION WAS TREATED BY PTA. THE PATIENT WAS A (B)(6) FEMALE WITH UNKNOWN MEDICAL HISTORY. THE ORIGINAL RATE OF STENOSIS WAS UNKNOWN AND THE SMART CONTROL STENTS WERE PLACED IN THE TARGET LESION WITHOUT ANY ISSUE. DETAILS REGARDING THE LESION AND VESSEL CHARACTERISTICS ARE UNKNOWN. THE LESION WAS PRE-DILATED PRIOR TO STENT IMPLANTATION BUT THE BALLOON SIZE AND INFLATION PRESSURE ARE NOT KNOWN. IT IS UNKNOWN IF THE TWO STENTS WERE OVERLAPPING AND IF ANY POST DILATION WAS PERFORMED. ADDITIONAL DETAILS REGARDING MEDICATIONS PRIOR, DURING OR POST PROCEDURE ARE UNKNOWN. THE PATIENT DID NOT HAVE ANY SYMPTOMS WHEN HE RETURNED AND THE RESTENOSIS WAS FOUND. IT IS ALSO UNKNOWN HOW THE RESTENOSIS WAS IDENTIFIED. THE PATIENT WAS REPORTED TO BE FINE AFTER TREATMENT FOR THE RESTENOSIS. THE PRODUCT REMAINS IMPLANTED AND IS THUS 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. 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. THIS IS ONE OF 2 PRODUCTS INVOLVED WITH THE REPORTED EVENT AND ARE ASSOCIATED MANUFACTURER REPORT NUMBERS 9616099-2014-00664 AND 9616099-2014-00665.

    Description of Event or Problem · 1

    AS REPORTED BY (B)(6), ON AN UNKNOWN DATE AFTER PLACEMENT OF 2 SMART CONTROL STENTS THE RIGHT SUPERFICIAL FEMORAL ARTERY, 50-99% RESTENOSIS WAS FOUND. THE LESION WAS TREATED BY PTA. THE PATIENT WAS A (B)(6) FEMALE WITH UNKNOWN MEDICAL HISTORY. THE ORIGINAL RATE OF STENOSIS WAS UNKNOWN AND THE SMART CONTROL STENTS WERE PLACED IN THE TARGET LESION WITHOUT ANY ISSUE. DETAILS REGARDING THE LESION AND VESSEL CHARACTERISTICS ARE UNKNOWN. THE LESION WAS PRE-DILATED PRIOR TO STENT IMPLANTATION BUT THE BALLOON SIZE AND INFLATION PRESSURE ARE NOT KNOWN. IT IS UNKNOWN IF THE TWO STENTS WERE OVERLAPPING AND IF ANY POST DILATION WAS PERFORMED. ADDITIONAL DETAILS REGARDING MEDICATIONS PRIOR, DURING OR POST PROCEDURE ARE UNKNOWN. THE PATIENT DID NOT HAVE ANY SYMPTOMS WHEN HE RETURNED AND THE RESTENOSIS WAS FOUND. IT IS ALSO UNKNOWN HOW THE RESTENOSIS WAS IDENTIFIED. THE PATIENT WAS REPORTED TO BE FINE AFTER TREATMENT FOR THE RESTENOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660715 SMART CONTROL NITINOL STENT SYSTEM SELF EXPANDING STENTS (FGE) FGE CORDIS CORPORATION C06150ML 15851700

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| L| R