BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SMART

    MDR report key: 7110597 · Received December 12, 2017

    Report

    Report Number
    9616099-2017-01679
    Event Type
    Injury
    Date Received
    December 12, 2017
    Date of Event
    June 15, 2016
    Report Date
    December 12, 2017
    Manufacturer
    CORDIS CORPORATION
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS FOUND DURING A RECENT CLINICAL EVALUATION REVIEW/LITERATURE SEARCH OF THIS DEVICE. THE CITATION IS AS FOLLOWS: MIKI, K. ET AL (2016). COMPARING THE VASCULAR RESPONSE IN IMPLANTATION OF SELF-EXPANDING, BARE METAL NITINOL STENTS OR PACLITAXEL-ELUTING NITINOL STENTS IN SUPERFICIAL FEMORAL ARTERY LESIONS: A SERIAL OPTICAL FREQUENCY DOMAIN IMAGING STUDY. EUROINTERVENTION, 12(12), 1551-1558. COMPLAINT CONCLUSION: AS NOTED IN THE LITERATURE PUBLICATION, MIKI ET AL COMPARING THE VASCULAR RESPONSE IN IMPLANTATION OF SELF-EXPANDING, BARE METAL NITINOL STENTS OR PACLITAXEL-ELUTING NITINOL STENTS IN SUPERFICIAL FEMORAL ARTERY LESIONS: A SERIAL OPTICAL FREQUENCY DOMAIN IMAGING STUDY. EUROINTERVENTION 2016;11:1551-1558; REPORT 1 EVENT OF DISSECTION IN THE BARE METAL STENT GROUP TREATED WITH SMART STENTS. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. DISSECTION IS A WELL-KNOWN AND EXTENSIVELY DOCUMENTED POTENTIAL COMPLICATION OF THIS TYPE OF PROCEDURE AND IS LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS SUCH. VESSELS THAT ARE RESISTANT TO ANGIOPLASTY HAVE A HIGHER RISK OF INTIMAL DISSECTION DURING INTERVENTIONAL PROCEDURES. THE PHYSICAL MANIPULATION INHERENT IN THE STENT IMPLANTATION PROCEDURE INTENTIONALLY DISRUPTS THE VESSEL PLAQUE AND INTIMA IN AN EFFORT TO RECONSTRUCT VIABLE PATENT VASCULATURE AND TREAT THE ATHEROSCLEROTIC DISEASE PROCESS. THERE IS NO EVIDENCE TO SUGGEST THERE WERE ANY MANUFACTURING ISSUES THAT CONTRIBUTED TO THE REPORTED EVENT. THIS DOES NOT REPRESENT DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    AS NOTED IN THE LITERATURE PUBLICATION, MIKI ET AL COMPARING THE VASCULAR RESPONSE IN IMPLANTATION OF SELF-EXPANDING, BARE METAL NITINOL STENTS OR PACLITAXEL-ELUTING NITINOL STENTS IN SUPERFICIAL FEMORAL ARTERY LESIONS: A SERIAL OPTICAL FREQUENCY DOMAIN IMAGING STUDY. EUROINTERVENTION 2016;11:1551-1558; REPORT 1 EVENT OF DISSECTION IN THE BARE METAL STENT GROUP TREATED WITH SMART STENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889498 UNKNOWN SMART CATHETER, BILIARY, DIAGNOSTIC FGE CORDIS CORPORATION NXXXXX UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention