BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 1080183 · Received July 21, 2008

    Report

    Report Number
    9616099-2008-01807
    Event Type
    Injury
    Date Received
    July 21, 2008
    Date of Event
    January 21, 2008
    Report Date
    June 24, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    K021898
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS DISTRIBUTED OUTSIDE THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE US DISTRIBUTED DRUG-ELUTING STENTS. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT. THE ASSOCIATED MANUFACTURER REPORT NUMBER IS 9616099-2008-01809. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    POST-PROCEDURE DUPLEX SHOWED RE-OCCLUSION OF THE INDEX LESION DUE TO INADEQUATE COVERAGE OF INDEX LESION WITH THE STENTS. THE LEFT SFA RETHROMBOSIS TREATED WITH ANGIOJET AND ADDITIONAL STENT PLACED IN PROXIMAL PART OF THE LESION. ACCESS METHOD WAS PERCUTANEOUS AND PUNCTURE SITE IPSILATERAL. NO PRE-DILATION WAS DONE. TWO SMART STENTS (2X 7X100MM) WERE IMPLANTED IN THE LEFT PROXIMAL, MID AND DISTAL SFA. POST-DILATION WAS DONE WITH A CORDIS OPTA PRO BALLOON (6X40MM). THE VESSEL ANATOMY AT THE LESION SITE WAS STRAIGHT AND TYPE OF LESION DE NOVO. LESION LOCATION WAS 9 CM ABOVE THE UPPER BORDER OF THE PATELLA. TOTAL LESION LENGTH WAS 180MM OF WHICH 120MM WAS OCCLUDED. REFERENCE VESSEL DIAMETER 6.0MM. PERCENTAGE STENOSIS AFTER STENT PLACEMENT WAS 10%. NO DISSECTIONS WERE REPORTED DURING PROCEDURE. PATIENT WAS DISCHARGED IN 2008.

    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 13216748

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention AMOUNT USED WAS 100ML| DEVICES: CATHETERS/CSI USED: TERUMO SHEATH 6F| TERUMO/GLIDE| MEDICATIONS: ACE INHIBITORS| BOSTON/ AMPLATZ SUPER STIFF| TERUMO/ STIFF GLIDE| GUIDEWIRES USED: COOK/BENTSON| STATINS| CLOPIDOGREL| ASPIRIN| TYPE OF CONTRAST AGENT USED WAS OMNIPAQUE 300| TERUMO STRAIGHT CATEHTER 5F