BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 1053329 · Received May 22, 2008

    Report

    Report Number
    9616099-2008-01378
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    January 8, 2008
    Report Date
    May 7, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    K021898
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICATION AT BASELINE: ASPIRIN, BETA BLOCKING AGENTS, STATINS, ANTAGONISTS RECEPTORS ANGIOTENSINE II, ZYLORIC. MEDICATION AT DISCHARGE: ASPIRIN, BETA BLOCKING AGENTS, STATINS, CLOPIDOGREL, LOW-MOLECULAR-WEIGHT HEPARIN. ANTAGONISTS RECEPTORS ANGIOTENSINE II, ZYLORIC. FOUR MONTHS POST IMPLANT THERE WAS 60% STENOSIS IN THE LEFT SFA. THE SEVERITY WAS MILD, TREATMENT WAS NOT PERFORMED AND EVENT IS STILL ONGOING. PER PROCEDURAL PERSONNEL, THE "STENOSIS" IS UNRELATED TO BOTH THE DEVICE AND THE PROCEDURE. IN ADDITION EIGHT MONTHS AFTER THE STENTS IMPLANT, STENT WAS NOTICED FRACTURE. NOTE: AT THIS TIME IT IS NOT KNOWN IF THE REPORTED "STENOSIS" IS RESTENOSIS OF THE PREVIOUSLY TREATED LESION. THE PRODUCT(S) REMAINS IMPLANTED IN THE PATIENT AND ARE NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SENT WITHIN 30 DAYS UPON RECEIPT. THIS IS ONE OF FOUR PRODUCTS INVOLVED IN THE SAME PATIENT AND REPORTED UNDER MANUFACTURING NUMBER 9616099-2008-01378, 9616099-2008-01380 AND 9616099-2008-01381.

    Description of Event or Problem · 1

    REPORT RECEIVED INDICATED 60% STENOSIS OF THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) AND ONE STENT FRACTURE. THE PATIENT WAS ENROLLED IN THE COBRA STUDY (INVESTIGATING BIOMECHANICS OF FEMORAL ARTERIES PRE AND POST STENTING). THE PROCEDURE WAS PERFORMED IN 2007 AND FOUR SMART CONTROL STENTS WERE IMPLANTED THE LEFT SFA. NO OTHER LESION/VESSEL SPECIFICS WERE PROVIDED. TYPE OF CONTRAST AGENT USED DURING THE PROCEDURE WAS HEXABRIX 320 FOR A TOTAL OF 250ML. THE PATIENT WAS DISCHARGED ON THE NEXT DAY.

    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 13177942

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other TERUMO STIFF 260| SHEATH SUPER AMON 45CM 6F| MPA 100CM I-O-TE 4F| RDC 80CM TEMPO/CORDIS 4F| ALL 0.035 INCH| TERUMO HYDROPHILIC 150| ROSEN 260| SHEATH SUPER AMON 65CM 7F| GLIDECATH 100CM 4F. 150CM