BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIROLIMUS COATED SMART STENT

    MDR report key: 1021018 · Received March 26, 2008

    Report

    Report Number
    9616099-2008-00756
    Event Type
    Injury
    Date Received
    March 26, 2008
    Date of Event
    July 30, 2003
    Report Date
    December 21, 2006
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION TO BE SUBMITTED 30 DAYS UPON RECEIPT. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS TWO CORDIS PRODUCTS WITH THE SAME CATALOG AND LOT NUMBERS. THIS PRODUCT IS DISTRIBUTED OUTSIDE THE UNITED STATES, BUT IS SIMILAR TO US DISTRIBUTED STENT DELIVERY SYSTEMS.

    Description of Event or Problem · 1

    IN 2003, THE PATIENT PRESENTED HIMSELF WITH CLAUDICATION COMPLAINTS. A DUPLEX ULTRASOUND REVEALED AN OCCLUSION OF THE WHOLE SFA, INCLUDED THE SIROCCO STENTED AREA. THE PATIENT IS A MALE. THE TARGET LESION WAS THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). THE INDEX PROCEDURE WAS PERFORMED IN 2002. MEDICAL HISTORY INCLUDES SMOKING AND PERIPHERAL VASCULAR DISEASE (FEMORAL ARTERY). ASPIRIN WAS GIVEN 24 HOURS PRIOR TO THE PROCEDURE. HEPARIN WAS GIVEN IN THE BEGINNING OF THE PROCEDURE. THE PHYSICIAN USED A CONTRALATERAL APPROACH TO ACCESS THE LESION. THE VESSEL WAS STRAIGHT AT THE LESION SITE. THE LESION WAS DESCRIBED AS DE NOVO, CALCIFIED, ECCENTRIC, OCCLUDED. LESION LENGTH : 140.00 MM. LESION PRE-DILATED (8 ATM) PERCENTAGE STENOSIS AFTER PRE DILATION = 60%. NO DISSECTION. ONE SMART STENT WAS IMPLANTED IN THE LESION. POST-DILATION (7 ATM). PERCENTAGE STENOSIS AFTER STENT PLACEMENT = 0%. NO DISSECTION WAS REPORTED. IN 2003, AFTER THE 9 MONTH FU VISIT, THE INVESTIGATOR PERFORMED A LASER ABLATION FOLLOWED BY PTA OF THE OCCLUSION AND PLACEMENT OF A STENT PROXIMAL OF THE SIROCCO STENTED AREA. IN 2004 (EXACT DATE UNKNOWN), THE PATIENT SUFFERED AN OCCLUSION OF THE RIGHT SUPERFICIAL FEMORAL ARTERY. TREATMENT WAS ONGOING. THE PATIENT EXPIRED FROM LUNG CANCER APPROXIMATELY 2 YEARS FOLLOWING THE INDEX PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIROLIMUS COATED SMART STENT SELF EXPANDING STENTS NIM CORDIS DE MEXICO NA T0702005

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Life Threatening| R