BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIC¿ VASCULAR

    MDR report key: 3030555 · Received April 2, 2013

    Report

    Report Number
    2134265-2013-01957
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    February 1, 2013
    Report Date
    March 4, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIO
    PMA / PMN Number
    P110035
    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 MANUFACTURER: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. HE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED UPON ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2013. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE THE STENT WAS NOT WELL APPOSED. VASCULAR ACCESS WAS OBTAINED WITH A NON BSC SHEATH VIA THE LEFT FEMORAL ARTERY. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE NON CALCIFIED AND MODERATELY TORTUOUS COMMON ILIAC ARTERY (CIA). A 8×40MM EPIC VASCULAR STENT DELIVERY SYSTEM (SDS) WAS ADVANCED AND SUCCESSFULLY IMPLANTED AT THE EXTERNAL ILIAC ARTERY. A 9X40X75MM EPIC VASCULAR STENT DELIVERY SYSTEM WAS ADVANCED AND SUCCESSFULLY PLACED FROM THE OSTIUM OF THE COMMON ILIAC ARTERY (CIA). DURING WITHDRAWAL OF THE 9X40X75MM EPIC VASCULAR SDS RESISTANCE WAS ENCOUNTERED WHEN REMOVING THE SDS FROM STENT. HOWEVER, THE PHYSICIAN MANAGED TO REMOVE THE SDS. POST DILATION WAS PERFORMED WITH A 6X40MM MUSTANG BALLOON CATHETER. IT WAS NOTED THAT "THERE IS A POSSIBILITY THAT THE STENT WAS NOT WELL APPOSED." THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS LISTED AS GOOD. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134171 EPIC¿ VASCULAR STENT, ILIAC NIO BOSTON SCIENTIFIC - MAPLE GROVE H74939200094070 15625817

    Patients

    Seq Age Sex Outcome Treatment
    1 INTRODUCER SHEATH, SHEATHLESS PV| STENT, EPIC 8×40 MM