BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 1111928 · Received August 11, 2008

    Report

    Report Number
    9616099-2008-01952
    Event Type
    Injury
    Date Received
    August 11, 2008
    Date of Event
    May 3, 2007
    Report Date
    July 14, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    K021898
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVAL AND TESTING. ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    AS REPORTED BY THE STUDY, CORE LAB RESULTS SHOWED RESTENOSIS IN THE 6 X 60 SMART CONTROL STENT ON DOPPLER ULTRASOUND IN 2007. THIS WAS THE PATIENT'S 8 MONTH FOLLOW-UP. PSV WAS NOTED AS 320MM/S AT THIS TIME. THERE ARE NO RECORDS OF THE RESTENOSIS BEING TREATED, AND IT WAS NOTED THAT THE PT REFUSED TO COME FOR THEIR 12 MONTH FOLLOW-UP VISIT; THEREFORE, NO ADDITIONAL CORELAB ANALYSES COULD BE PERFORMED. INDEX PROCEDURE DATA: HEPARIN WAS GIVEN AT THE BEGINNING OF THE PROCEDURE, TOTAL DOSE USED DURING PROCEDURE WAS 5000IU. ACCESS METHOD WAS PERCUTANEOUS AND PUNCTURE SITE CONTRALATERAL. THE VESSEL ANATOMY AT THE LESION SITE WAS STRAIGHT, TYPE OF LESION DE NOVO, THE LESION WAS CALCIFIED AND ECCENTRIC. TWO SMART CONTROL STENTS (6X60 AND 6X100) WERE IMPLANTED IN THE LEFT DISTAL SFA. LESION LOCATION WAS 7CM ABOVE THE SUPERIOR EDGE OF THE PATELLA. TOTAL LESION LENGTH WAS 145MM OF WHICH 50MM WAS OCCLUDED. THERE WAS NO THROMBUS PRESENT AT THE SITE. REFERENCE VESSEL DIAMETER 5.0MM. PERCENTAGE STENOSIS BEFORE PROCEDURE WAS 90% AND AFTER STENT PLACEMENT AND POST-DILATION 0%. THERE WERE NO DISSECTIONS REPORTED DURING PROCEDURE. PT WAS DISCHARGED IN 2006. MEDICATION AT DISCHARGE: ASPIRIN AND CLOPIDOGREL.

    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 130806075

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other PRE-DILATION WAS DONE WITH A INVATEC/ SAILOR| BALLOON (4X180MM)| BALLOON (5X120MM)| POST-DILATION WAS DONE WITH A INVATEC/SUBMARINE