BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S.M.A.R.T. NITINOL STENT SYSTEM

    MDR report key: 1871339 · Received October 15, 2010

    Report

    Report Number
    9616099-2010-00799
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 6, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DHR FOR THE INVOLVED PRODUCTS COULD NOT BE PERFORMED, AS NO STERILE LOT NUMBERS WERE AVAILABLE. 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, 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. IN THE LITERATURE, IN-STENT STENOSIS RATES RANGE FROM (B)(4) FROM 6 TO 12 MONTHS AFTER STENT PLACEMENT. RATES WERE HIGHER IN OLDER PATIENTS WITH MORE SEVERE ATHEROSCLEROSIS AND DEPENDED ON THE TYPE OF STENOSIS TREATED. ISR IS MORE PREVALENT IN OSTIAL STENT PLACEMENT PROCEDURES. STENOSES IN STENTS ARE USUALLY TREATED WITH INTRASTENT PTA OR PLACEMENT OF A SECOND STENT. FACTORS THAT MAY HAVE INFLUENCED THIS EVENT INCLUDE PATIENT, PROCEDURAL, PHARMACOLOGICAL AND LESION.

    Description of Event or Problem · 1

    IN A COMPLAINT REPORT FROM (B)(6) REGARDING TWO CORDIS PTA BALLOONS, IT WAS NOTED WITHIN THE BODY OF THE COMPLAINT THAT ONE OF THE BALLOONS WAS BEING USED TO TREAT RESTENOSIS OF TWO UNKNOWN SIZE SMART CONTROL STENTS THAT HAD BEEN PREVIOUSLY PLACED IN THE LEFT SFA OF THIS PATIENT ON AN UNKNOWN DATE. THE RESTENOSIS WAS OBSERVED IN THE ENTIRE SFA WITH HEAVY CALCIFICATION, ALTHOUGH THE SMART CONTROL STENTS WERE NOT PLACED IN OVER-LAPPING FASHION. THE DATE OF IMPLANT, THE DATE THE RESTENOSIS WAS FOUND, AND OTHER PROCEDURAL DETAILS WERE NOT AVAILABLE PER THE REPORTING AFFILIATE. BOTH UNKNOWN SMART CONTROL DEVICES ARE BEING REPORTED HEREIN FOR RESTENOSIS, AS IT IS UNKNOWN IF ONE OR BOTH ACTUALLY RESTENOSED PER THE REPORTING AFFILIATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S.M.A.R.T. NITINOL STENT SYSTEM SELF EXPANDING STENTS (FGE) FGE CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR