BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT-FULLY COVERED

    MDR report key: 2935158 · Received January 25, 2013

    Report

    Report Number
    3001845648-2013-00010
    Event Type
    Injury
    Date Received
    January 25, 2013
    Date of Event
    December 31, 2012
    Report Date
    January 26, 2013
    Manufacturer
    COOK IRELAND LTD
    Product Code
    ESW
    PMA / PMN Number
    K080359
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SPECIFIC RPN AND LOT NUMBER OF THIS DEVICE WAS NOT PROVIDED. EVO-FC-20-25-12-E WAS USED FOR LOGGING PURPOSES. THE ACTUAL RPN OR LOT NUMBER OF THE EVOLUTION FULLY COVERED DEVICE INVOLVED IN THIS COMPLAINT WAS NOT PROVIDED. AS THE RPN OR LOT NUMBER WERE NOT PROVIDED, THEREFORE IT IS NOT POSSIBLE TO ESTABLISH IF THERE WERE ANY DEVICES FROM THE AFFECTED LOT NUMBERS IN STOCK AT THE TIME OF THE COMPLAINT INVESTIGATION. THE DEVICE INVOLVED IN THE COMPLAINT WAS NOT RETURNED FOR EVALUATION. WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. AS THE ACTUAL USE CONDITIONS CANNOT BE REPLICATED IN THE LABORATORY, THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED AND THE CAUSE OF THE COMPLAINT COULD NOT BE CONCLUSIVELY DETERMINED. THE COMPLAINT INFORMATION PROVIDED IN RELATION TO THIS COMPLAINT INDICATED THE FULLY COVERED STENT WAS PLACED FOR A BENIGN INDICATION. STENT DID BRIDGE THE LES. THE STENT KEPT MIGRATING INTO THE STOMACH. A PARTIALLY COVERED ESOPHAGEAL STENT WAS PLACED. AS PER THE INSTRUCTIONS FOR USE THAT ACCOMPANIES THIS DEVICE, IFU0061-4 "POTENTIAL COMPLICATIONS ASSOCIATED WITH UPPER GI ENDOSCOPY INCLUDE, BUT ARE NOT LIMITED TO STENT MISPLACEMENT AND/OR MIGRATION". THE COMPONENT INVOLVED IN THIS COMPLAINT IS THE ESOPHAGEAL STENT. PRIOR TO DISTRIBUTION ALL EVOLUTION ESOPHAGEAL DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THE MANUFACTURING RECORDS FOR THE DEVICE INVOLVED IN THIS COMPLAINT COULD NOT BE REVIEWED AS THE RPN AND LOT NUMBER WERE NOT PROVIDED. THE INSTRUCTIONS FOR USE, IFU0061-4, CONTAINS THE FOLLOWING PRECAUTION". THE STENT IS NOT INTENDED TO BE REMOVED AND IS CONSIDERED A PERMANENT IMPLANT ATTEMPTS TO REMOVE STENT AFTER PLACEMENT MAY CAUSE DAMAGE TO ESOPHAGEAL MUCOSA ". IT WAS NOT CONFIRMED IF THIS DEVICE WAS REMOVED WHEN A PARTIALLY COVERED ESOPHAGEAL STENT WAS PLACED. IFU0061-4 ALSO INCLUDES THE FOLLOWING PRECAUTIONS. "THE DEVICE IS INTENDED FOR PALLIATIVE TREATMENT ONLY. ALTERNATE METHODS OF THERAPY SHOULD BE INVESTIGATED PRIOR TO PLACEMENT" "LONG-TERM PATENCY OF THIS DEVICE HAS NOT BEEN ESTABLISHED PERIODIC EVALUATION IS ADVISED". THE 2 YEAR COMPLAINT HISTORY HAS BEEN REVIEWED AND THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS LOW. CUSTOMER QUALITY ASSURANCE WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    THE ACTUAL LOT NUMBER OF THE EVO-20-25-15-E DEVICE INVOLVED IN THIS COMPLAINT WAS NOT PROVIDED. AS THE LOT NUMBER WAS NOT PROVIDED; THEREFORE IT IS NOT POSSIBLE TO ESTABLISH IF THERE WERE ANY DEVICES FROM THE AFFECTED LOT NUMBERS IN STOCK AT THE TIME OF THE COMPLAINT INVESTIGATION. 1 X PARTIALLY COVERED EVOLUTION STENT OF UNKNOWN LOT NUMBER WAS RETURNED FOR EVALUATION. IT WAS NOT RETURNED IN THE ORIGINAL PACKAGE. IT WAS MEASURED AND NOTED TO BE APPROX. 15CM IN LENGTH. THE COATING OF THE STENT WAS NOTED TO HAVE DISINTEGRATED. THE COATING WAS VERY BADLY DISCOLOURED AND WAS PEELING FROM THE METAL STENT. THE DISTAL END OF STENT WAS NOTED TO BE FRACTURED, WITH THE STRUTS BROKEN AND FRAYED. NO LASSO LOOP WAS PRESENT ON THE RETURNED DEVICE. THE CUSTOMER COMPLAINT WAS CONFIRMED AS THE COATING OF THE STENT WAS NOTED TO HAVE DISINTEGRATED, THE DISTAL END OF STENT WAS NOTED TO FRACTURED, WITH THE STRUTS BROKEN / FRACTURED AND NO LASSO LOOP WAS PRESENT ON THE RETURNED DEVICE. A POSSIBLE CAUSE OF THE DAMAGE NOTED TO THIS STENT COULD BE IF THE STENT WAS IN CONTACT WITH STOMACH ACID FOR A LONG PERIOD OF TIME, HOWEVER THIS CANNOT BE CONFIRMED. THE LASSO LOOP MOST LIKELY BROKE DUE TO THE FORCE USED TO REMOVE THE PERMANENT STENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT PROVIDED TO DATE. IT CAN BE NOTED THAT THIS STENT WAS IMPLANTED IN OCTOBER 2010 AND NOT REMOVED UNTIL AUGUST 2012, OR LATER (REMOVAL DATE NOT CONFIRMED). AS PER THE INSTRUCTIONS FOR USE THAT ACCOMPANIES THIS DEVICE, IFU0061-4: ¿THE DEVICE IS INTENDED FOR PALLIATIVE TREATMENT ONLY. ALTERNATE METHODS OF THERAPY SHOULD BE INVESTIGATED PRIOR TO PLACEMENT¿. "LONG-TERM PATENCY OF THIS DEVICE HAS NOT BEEN ESTABLISHED. PERIODIC EVALUATION IS ADVISED." THE DEVICES ARE NOT INTENDED TO BE REMOVED AND ARE CONSIDERED A PERMANENT IMPLANT. THE COMPLAINT INFORMATION INDICATED THAT THIS STENT WAS REMOVED APPROX. 2 YEARS AFTER PLACEMENT. THE INSTRUCTIONS FOR USE, IFU0061-4, CONTAINS THE FOLLOWING PRECAUTION: "THE STENT IS NOT INTENDED TO BE REMOVED AND IS CONSIDERED A PERMANENT IMPLANT. ATTEMPTS TO REMOVE STENT AFTER PLACEMENT MAY CAUSE DAMAGE TO ESOPHAGEAL MUCOSA". THE COMPONENT INVOLVED IN THIS COMPLAINT IS THE ESOPHAGEAL STENT - RMN 12-442. PRIOR TO DISTRIBUTION ALL EVOLUTION® ESOPHAGEAL DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THE MANUFACTURING RECORDS FOR THE DEVICE INVOLVED IN THIS COMPLAINT COULD NOT BE REVIEWED AS THE LOT NUMBER WAS NOT PROVIDED. THE 2 YEAR COMPLAINT HISTORY HAS BEEN REVIEWED AND THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS LOW. CUSTOMER QUALITY ASSURANCE WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    A FULLY COVERED STENT KEPT MIGRATING INTO THE STOMACH IN (B)(6) 2010 PARTIALLY COVERED ESOPHAGEAL STENT WAS PLACED SUBSEQUENTLY ALL STENTS WERE REMOVED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Description of Event or Problem · 0

    THE INITIAL PLACEMENT WAS IN (B)(6) 2010. IN (B)(6) 2012 PHYSICIAN DISCOVERED THAT THE BOTTOM HALF OF THE ORIGINAL PARTIALLY COVERED STENT (THE PART OF THE STENT THAT WAS BELOW THE FULLY COVERED STENT PLACED INSIDE OF IT) HAD DETERIORATED AND FRAYED OPEN AT THE DISTAL END. IT APPEARED THAT THE SLEEVE (COATING OF THE STENT) SLID DOWN THEREFORE EXPOSING A BARE STENT, RESULTING IN MORE TISSUE INGROWTH WHICH FURTHER INHIBITED THE STENT'S REMOVAL. THE STRING (LASSO LOOP) BROKE ON REMOVAL OF THE PERMANENT STENT MAKING IT MORE DIFFICULT TO REMOVE (BUT SUBSEQUENTLY WAS SUCCESSFULLY REMOVED). A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. AN ADDITIONAL PROCEDURE WAS REQUIRED TO REMOVE THE STENT . ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109208 EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT-FULLY COVERED ESW PROSTHESIS, ESOPHAGEAL ESW COOK IRELAND LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention