BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIC? VASCULAR

    MDR report key: 3190551 · Received June 26, 2013

    Report

    Report Number
    2134265-2013-04380
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 29, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIO
    PMA / PMN Number
    P110035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MFR.: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS 2134265-2013-04382. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY, STENT MIGRATION OCCURRED. ACCESS WAS OBTAINED VIA LEFT COMMON FEMORAL ARTERY. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED COMMON ILIAC ARTERY. AFTER INSERTING AN 6F SHEATH, A 10X40X120 EPIC VASCULAR STENT WAS ADVANCED TO THE LEFT COMMON ILIAC ARTERY OSTIAL WITH A 035 RADIFOCUS GLIDEWIRE. WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, IT WAS PUSHED OUT AND IT WENT BEYOND THE TARGET LESION'S SITE. THE PROCEDURE WAS COMPLETED IMPLANTING AN ADDITIONAL NON-BSC STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD. THE SAME DAY, ANOTHER PROCEDURE WAS PERFORMED ON THE SAME PATIENT. VASCULAR ACCESS WAS OBTAINED VIA RIGHT COMMON FEMORAL ARTERY. THE 90% STENOSED TARGET LESION WAS A 10MM LESION LOCATED IN THE SEVERELY CALCIFIED AND MILDLY TORTUOUS EXTERNAL ILIAC ARTERY SIDE FROM OSTIAL OF RIGHT COMMON ILIAC ARTERY. AFTER INSERTING A 6F NON-BSC SHEATH, A 6X4MM MUSTANG BALLOON CATHETER WAS USED TO PREDILATE THE LESION. FOLLOWING PREDILATATION, A 10X40X75 EPIC VASCULAR STENT DELIVERY SYSTEM WAS ADVANCED AND THE STENT WAS DEPLOYED. HOWEVER, THE STENT CAME OUT OF THE AORTA UPON DEPLOYMENT INSTEAD ON THE TARGET LESION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291284 EPIC? VASCULAR STENT, ILIAC NIO BOSTON SCIENTIFIC - MAPLE GROVE H74939200104020 15744039

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INTRODUCER SHEATH:6F ARROW| INFLATION DEVICE:ENCORE 26| STENT:EPIC| GUIDEWIRE:RADIFOCUS 035| BALLOON CATHETER:MUSTANG 6*4