BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1111934 · Received August 11, 2008

    Report

    Report Number
    9616099-2008-01947
    Event Type
    Injury
    Date Received
    August 11, 2008
    Date of Event
    February 7, 2007
    Report Date
    July 14, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT WAS ADMITTED FOR THE INDEX (PTA) PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY WITH A LESION LOCATED FROM THE DISTAL EDGE OF THE SUPERIOR EDGE OF THE PATELLA WAS 8CM WITH A TOTAL LESION LENGTH OF 200 MM AND OCCLUDED LENGTH OF 100 MM. THE LESION WAS DE NOVO AND CALCIFIED, THE VESSEL WAS STRAIGHT AT THE LESION SITE. THE PATIENT'S MEDICAL HISTORY WAS DOCUMENTED TO BE PERIPHERAL VASCULAR DISEASE, SUFFERS FROM (PVD) PERIPHERAL VASCULAR DISEASE FOR MORE THAN 1 YEAR. NONE CURRENT SMOKER, BUT HAS SMOKED IN THE PAST 10 YEARS. THE PT RECEIVED HEPARIN AT THE BEGINNING OF THE PROCEDURE. THE TOTAL DOSE GIVEN DURING THE PROCEDURE WAS 5000 IU. THE ACCESS METHOD WAS PERCUTANEOUS AND PUNCTURE SITE WAS CONTRALATERAL. THERE WAS 95% STENOSIS BEFORE THE PROCEDURE, AND 0 PERCENTAGE AFTER THE PROCEDURE. AFTER PRE-DILATATION WITH 5 X 120 MM BALLOON (SAILOR/INVATEC), TWO 6 X 120 MM SMART STENTS WERE DEPLOYED IN THE RIGHT MID (SFA) SUPERFICIAL FEMORAL ARTERY. POST DILATATION WAS CONDUCTED WITH 5 X 120 MM BALLOON (SAILOR/INVATEC). MEDICATION AT DISCHARGED CONSISTED OF ASPIRIN AND CLOPIDOGREL. ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    PER THE STUDY, SIXTEEN MONTHS AFTER UNDER DUAL STENT IMPLANTATION, THE 12 MONTHS FOLLOW-UP SHOWED RESTENOSIS IN STENT THE SECOND SMART STENT. THE LESION SITE WAS PROXIMAL AND MID. THE FLOW IN THE SECOND STENT WAS 450MM/S IN THE PROXIMAL PORTION AND 225MM/S IN THE MID SECTION. PLEASE NOTE THAT NO FURTHER INFO IS AVAILABLE. BASED ON THE INFO, BOTH STENTS WERE REPORTED BECAUSE THE OTHER STENT MAY HAVE BEEN WITHIN 5MM OF THE PROXIMAL LESION.

    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 50305041

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization 5 X 120 MM BALLOON (SAILOR/INVATEC)