BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIC¿

    MDR report key: 2212515 · Received August 16, 2011

    Report

    Report Number
    2134265-2011-03535
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 19, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    FGE
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: RECEIVED PRODUCT CONSISTED OF AN EPIC VASCULAR DEVICE WITH BLOOD WAS VISIBLE IN THE SHAFT. THE STENT WAS NOT RECEIVED. MAGNIFIED INSPECTION REVEALED THE INNER SHAFT WAS KINKED IN NUMEROUS LOCATIONS. THE FLOATING AND FIXED BUMPERS WERE INTACT AND DID NOT REVEAL ANY DAMAGE. THE 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

    IT WAS REPORTED THAT DURING A PERIPHERAL STENTING TREATMENT PROCEDURE, DEPLOYMENT ISSUES OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS BIFURCATION OF THE SUPERFICIAL FEMORAL ARTERY INTO THE POPLITEAL ARTERY. A EPIC VAS 6X120X120 STENT WAS ADVANCED TO TREAT THE LESION. DURING DEPLOYMENT, THE FIRST 3CM OF THE STENT STARTED "WELL" THEN THE REMAINING 9CM OF THE STENT "RECOILED". THE STENT WAS COMPLETELY DEPLOYED IN THE INTENDED LOCATION; HOWEVER, MOST OF THE WORKING LENGTH APPEARS "WINDING" AND WAS UNABLE TO BE CROSSED AGAIN WITH UNSPECIFIED BALLOONS. THE PATIENT REMAINS HOSPITALIZED IN STABLE CONDITION. THIS PRODUCT IS ONLY OUS APPROVED BUT IS SIMILAR TO AN APPROVED US DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERIPHERAL STENTING TREATMENT PROCEDURE, DEPLOYMENT ISSUES OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS BIFURCATION OF THE SUPERFICIAL FEMORAL ARTERY INTO THE POPLITEAL ARTERY. A EPIC VAS 6X120X120 STENT WAS ADVANCED TO TREAT THE LESION. DURING DEPLOYMENT, THE FIRST 3CM OF THE STENT STARTED "WELL" THEN THE REMAINING 9CM OF THE STENT "RECOILED". THE STENT WAS COMPLETELY DEPLOYED IN THE INTENDED LOCATION; HOWEVER, MOST OF THE WORKING LENGTH APPEARS "WINDING" AND WAS UNABLE TO BE CROSSED AGAIN WITH UNSPECIFIED BALLOONS. THE PATIENT REMAINS HOSPITALIZED IN STABLE CONDITION. THIS PRODUCT IS ONLY OUS APPROVED BUT IS SIMILAR TO AN APPROVED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPIC¿ CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - MAPLE GROVE H74939054061220 13776036

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization