BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART 120 150, SFA - 6X150MM

    MDR report key: 7088315 · Received December 6, 2017

    Report

    Report Number
    9616099-2017-01666
    Event Type
    Injury
    Date Received
    December 6, 2017
    Date of Event
    October 17, 2017
    Report Date
    January 19, 2018
    Manufacturer
    CORDIS CORPORATION
    Product Code
    FGE
    UDI-DI
    20705032063408
    PMA / PMN Number
    K042969
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION RECEIVED THE SECTIONS HAVE BEEN UPDATED ACCORDINGLY. AS REPORTED BY THE SMART PMS FOR SFA STUDY, FOUR YEARS POST IMPLANTATION OF A THREE SMART SELF¿EXPANDING STENTS (SES), SMART 120 150, TWO SFA - 6X150MM AND ONE SMART CONTROL ILIAC 8X60ML, ON THE SUPERFICIAL FEMORAL ARTERY (SFA), THE PATIENT WAS HOSPITALIZED DUE TO IN-STENT RESTENOSIS AND PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS PERFORMED FOR TARGET LESION REVASCULARIZATION (TLR). THE TOTAL LENGTH OF THE STENTED SEGMENT IS 360MM (150¿+150¿+60¿). THERE WERE THREE (3) STENTS PLACED. THE RESTENOSIS WAS LOCATED INSIDE AND ON THE EDGE OF THE STENT. THE TARGET LESION WAS IN-STENTS AND THE EDGE OF THE STENTS. THE PATIENT RECOVERED. NONE OF THESE EVENTS WERE RELEVANT TO THE INDEX PROCEDURE OR THE CORDIS PRODUCT. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. IN-STENT RESTENOSIS (ISR) IS ASSOCIATED WITH THE PROGRESSION OF ATHEROSCLEROTIC DISEASE AND IS A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING STENT IMPLANTATION AND DOES NOT REPRESENT A DEVICE FAILURE. INTRA-ARTERIAL STENT PLACEMENT IS A TREATMENT OF THE DISEASE PROCESS, IT IS NOT A PREVENTIVE OR CURE FOR THE PROGRESSION OF SYMPTOMS OF ATHEROSCLEROTIC ARTERY DISEASE. PERIPHERAL REVASCULARIZATION IS NECESSARY TO REOPEN AN IN-STENT RESTENOSIS CAUSED BY NEOINTIMAL HYPERPLASIA AND THE ONGOING DISEASE PROCESS. NEOINTIMAL HYPERPLASIA REFERS TO PROLIFERATION AND MIGRATION OF VASCULAR SMOOTH MUSCLE CELLS PRIMARILY IN THE TUNICA INTIMA, RESULTING IN THE THICKENING OF ARTERIAL WALLS AND DECREASED ARTERIAL LUMEN SPACE. NEOINTIMAL HYPERPLASIA IS THE MAJOR CAUSE OF RESTENOSIS AFTER PERCUTANEOUS INTERVENTIONS SUCH AS STENTING OR ANGIOPLASTY. STENOSIS IN STENTS ARE USUALLY TREATED WITH INTRASTENT PTA OR PLACEMENT OF A SECOND STENT. FACTORS THAT MAY HAVE INFLUENCED THIS EVENT INCLUDE PATIENT, PROCEDURAL, PHARMACOLOGICAL AND LESION. NEITHER THE DHR NOR THE INFORMATION AVAILABLE SUGGESTS A DESIGN OR MANUFACTURING RELATED CAUSE FOR THE REPORTED BURST; THEREFORE, NO CORRECTIVE/PREVENTIVE ACTION WILL BE TAKEN. THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THE REPORTED EVENT AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2017-01667 AND 9616099-2017-01668.

    Description of Event or Problem · 1

    AS REPORTED BY THE SMART PMS FOR SFA STUDY, FOUR YEARS POST IMPLANTATION OF A THREE SMART (SMART 120 150, SFA - 6 X 150 MM / SMART CONTROL, ILIAC 8 X 60 ML) SELF¿EXPANDING STENTS (SES) ON THE SUPERFICIAL FEMORAL ARTERY, THE PATIENT WAS HOSPITALIZED DUE TO IN-STENT RESTENOSIS AND PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS PERFORMED FOR TARGET LESION REVASCULARIZATION. THE TOTAL LENGTH OF THE STENTED SEGMENT IS 360 MM (150+150+60). THERE WERE THREE (3) STENTS PLACED. THE RESTENOSIS WAS LOCATED INSIDE AND ON THE EDGE OF THE STENT. A NON-CORDIS STENT GRAFT WAS IMPLANTED. THE TARGET LESION WAS IN-STENTS AND THE EDGE OF THE STENTS. THE PATIENT RECOVERED. NONE OF THESE EVENTS WERE RELEVANT TO THE INDEX PROCEDURE OR THE CORDIS PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866059 SMART 120 150, SFA - 6X150MM CATHETER, BILIARY, DIAGNOSTIC FGE CORDIS CORPORATION UNKNOWN 20705032063408

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| L| R| S