BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 5397104 · Received January 28, 2016

    Report

    Report Number
    9616099-2016-00044
    Event Type
    Injury
    Date Received
    January 28, 2016
    Date of Event
    January 6, 2016
    Report Date
    January 6, 2016
    Manufacturer
    CORDIS CORPORATION
    Product Code
    FGE
    PMA / PMN Number
    P120002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE PMA/510K NUMBER PROVIDED P120002 IS FOR A S.M.A.R.T. NITINOL STENT SYSTEM BUT SINCE THE ACTUAL PRODUCT CATALOG/LOT NUMBER IS UNKNOWN, THE PMA/510K NUMBER CANNOT BE VERIFIED. AS REPORTED, DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) FOR TREATMENT OF AN IN-STENT-RESTENOSIS (ISR) OF AN UNKNOWN SMART STENT, THE 155 CM. SLEEK 4.0 X 220 BALLOON CATHETER RUPTURED AT EIGHT ATMOSPHERES (8 ATM.) OF PRESSURE. THE PRODUCT WAS EXCHANGED SUCCESSFULLY FOR ANOTHER SAME SIZE SLEEK BC TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS CLINICALLY USED AND IT WILL NOT BE RETURNED FOR ANALYSIS. THE TARGET LESION WAS THE LEFT SUPERFICIAL FEMORAL ARTERY (LSFA). THE LESION WAS REPORTED TO BE: A 95% STENOSIS, MODERATELY CALCIFIED AND MILDLY TORTUOUS. AN UNKNOWN GUIDEWIRE WAS USED TO ACCESS THE TARGET LESION. ADDITIONAL INFORMATION RECEIVED IN REGARDS TO THE SMART STENT INDICATED THAT THERE WAS NO INFORMATION AVAILABLE SUCH AS: THE PRODUCT CATALOG/LOT NUMBER, DATE OF IMPLANTATION, IF THERE WAS ANY REPORTED PRODUCT ISSUE OR ADVERSE EVENT REPORTED DURING THE INDEX PROCEDURE FOR THIS DEVICE, THE PATIENT¿S POST-PROCEDURE MEDICAL REGIMEN, OR IF THE PATIENT COMPLIANT WITH THE POST-PROCEDURE MEDICAL REGIMEN/ANTIPLATELET THERAPY. THE DEVICE REMAINS IMPLANTED IN THE PATIENT AND IS NOT AVAILABLE FOR INSPECTION. MANUFACTURING RECORDS (DHR) COULD NOT BE REVIEWED, AS THE PRODUCT CATALOG AND LOT NUMBER ARE NOT AVAILABLE. RESTENOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH IMPLANTING PERIPHERAL VASCULAR STENTS AND IS OFTEN ASSOCIATED WITH THE PROGRESSION OF PERIPHERAL VASCULAR DISEASE. BASED ON THE MINIMAL AVAILABLE INFORMATION THERE IS NO EVIDENCE TO SUGGEST THAT THE EVENT WAS DESIGN OR MANUFACTURING RELATED THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN. PLEASE NOTE THAT THIS IS THE INITIAL/FINAL REPORT FOR THIS PRODUCT.

    Description of Event or Problem · 1

    AS REPORTED, DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) FOR TREATMENT OF AN IN-STENT-RESTENOSIS (ISR) OF AN UNKNOWN SMART STENT, THE 155 CM. SLEEK 4.0 X 220 BALLOON CATHETER RUPTURED AT EIGHT ATMOSPHERES (8 ATM.) OF PRESSURE. THE PRODUCT WAS EXCHANGED SUCCESSFULLY FOR ANOTHER SAME SIZE SLEEK BC TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS CLINICALLY USED AND IT WILL NOT BE RETURNED FOR ANALYSIS. THE TARGET LESION WAS THE LEFT SUPERFICIAL FEMORAL ARTERY (LSFA). THE LESION WAS REPORTED TO BE: A 95% STENOSIS, MODERATELY CALCIFIED AND MILDLY TORTUOUS. AN UNKNOWN GUIDEWIRE WAS USED TO ACCESS THE TARGET LESION. ADDITIONAL INFORMATION RECEIVED IN REGARDS TO THE SMART STENT INDICATED THAT THERE WAS NO INFORMATION AVAILABLE SUCH AS: THE PRODUCT CATALOG/LOT NUMBER, DATE OF IMPLANTATION, IF THERE WAS ANY REPORTED PRODUCT ISSUE OR ADVERSE EVENT REPORTED DURING THE INDEX PROCEDURE FOR THIS DEVICE, THE PATIENT'S POST-PROCEDURE MEDICAL REGIMEN, OR IF THE PATIENT COMPLIANT WITH THE POST-PROCEDURE MEDICAL REGIMEN/ANTIPLATELET THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55470 S.M.A.R.T. NITINOL STENT SYSTEM SELF EXPANDING STENTS (FGE) FGE CORDIS CORPORATION NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening| R UNKNOWN 0.014 GUIDEWIRE