BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM

    MDR report key: 2083189 · Received May 10, 2011

    Report

    Report Number
    2134265-2011-01725
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 11, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DELIVERY DEVICE WAS RECEIVED FOR ANALYSIS WITH THE STENT DETACHED FROM THE BALLOON. THE STENT WAS RECEIVED IN A PLASTIC CONTAINER. AN EXAMINATION OF THE DELIVERY DEVICE FOUND THAT THE BALLOON HAD BEEN INFLATED AND WAS NOT REFOLDED. A CLEAR IMPRESSION WAS VISIBLE ALONG THE LENGTH OF THE BALLOON OF WHERE THE STENT HAD BEEN CRIMPED INITIALLY. A VISUAL EXAMINATION OF THE STENT FOUND THAT THE STENT WAS STRETCHED AND FLATTENED. 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).

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY ARTERY STENTING TREATMENT PROCEDURE A STENT DISLODGEMENT OCCURRED. THE LESION BEING TREATED WAS LOCATED IN THE SEVERELY TORTUOUS AND ANGULATED DISTAL RCA (RIGHT CORONARY ARTERY). THE PHYSICIAN CROSSED THE LESION WITH A 3.0X20MM BALLOON. THE 5.0X24MM VERIFLEX STENT DELIVERY SYSTEM WAS ADVANCED INTO THE BODY TWICE AND COULD NOT CROSS THE LESION. WHEN THE DELIVERY SYSTEM WAS REMOVED THE STENT DISLODGED INTO THE DESCENDING THORACIC AORTA. THE STENT WAS RETRIEVED USING A SNARE AND THE CASE WAS CONCLUDED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT HAD TIMI 3 FLOW POST PROCEDURE AND WAS TO BE SEEN IN THE OFFICE FOR FURTHER MEDICAL MANAGEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY ARTERY STENTING TREATMENT PROCEDURE A STENT DISLODGEMENT OCCURRED. THE LESION BEING TREATED WAS LOCATED IN THE SEVERELY TORTUOUS AND ANGULATED DISTAL RCA (RIGHT CORONARY ARTERY). THE PHYSICIAN CROSSED THE LESION WITH A 3.0X20MM BALLOON. THE 5.0X24MM VERIFLEX STENT DELIVERY SYSTEM WAS ADVANCED INTO THE BODY TWICE AND COULD NOT CROSS THE LESION. WHEN THE DELIVERY SYSTEM WAS REMOVED THE STENT DISLODGED INTO THE DESCENDING THORACIC AORTA. THE STENT WAS RETRIEVED USING A SNARE AND THE CASE WAS CONCLUDED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT HAD TIMI 3 FLOW POST PROCEDURE AND WAS TO BE SEEN IN THE OFFICE FOR FURTHER MEDICAL MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM STENT, CORONARY MAF BOSTON SCIENTIFIC - GALWAY H7493893424500 12824475

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention