BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED

    MDR report key: 7726157 · Received July 27, 2018

    Report

    Report Number
    3001845648-2018-00364
    Event Type
    Injury
    Date Received
    July 27, 2018
    Date of Event
    July 6, 2018
    Report Date
    July 27, 2018
    Manufacturer
    COOK IRELAND LTD
    Product Code
    ESW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    510(K) NUMBER: K162717. COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO SECTION G. 1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(4) COOK MEDICAL INCORPORATED (CMI) 1025 ACUFF ROAD P.O BOX 4195 BLOOMINGTON INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113. INVESTIGATION IS STILL PENDING, A FOLLOW UP REPORT WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    510(K) NUMBER: K162717. (B)(4). EXEMPTION NUMBER: E2016031. (B)(4). PROBLEM STATEMENT: THE STENT MIGRATED TOWARDS THE STOMACH. AS PER INITIAL NOTIFICATION: FULLY COVERED ESOPHAGEAL STENT WAS PLACED IN THE ESOPHAGUS AND THE STENT MIGRATED TOWARDS THE STOMACH. THE STENT WAS REPOSITIONED BY GRABBING THE STENT LOOP AT THE PROXIMAL END. ANOTHER FULLY COVERED STENT WAS PLACED INSIDE OF THE EXISTING STENT. 2ND PROCEDURE CARRIED OUT ON THE (B)(6) 2018. UNKNOWN DETAILS OF THE 1ST STENT PLACED. AS PER COMPLAINT FORM RECEIVED ON 10TH JULY 2018: THE ORIGINAL ESOPHAGEAL STENT WAS PLACED FOLLOWING A PERFORATION IN THE ESOPHAGUS. APPROX 6 WEEKS LATER ON THE (B)(6) 2018 DR ATTEMPTED TO REMOVE THE STENT. THE STENT HAD MIGRATED INTO THE STOMACH AT THE DISTAL END AND THERE WAS TISSUE INGROWTH AT THE PROXIMAL END OF THE STENT MAKING IT NOT POSSIBLE TO REMOVE THE STENT. A SECOND FULLY COVERED 10CM ESOPHAGEAL STENT WAS PLACED INSIDE (TO OVERLAP THE EXISTING STENT) TO CAUSE TISSUE NECROSIS FOR THE REMOVAL OF BOTH STENTS IN 2 WEEKS TIME. DEVICE EVALUATION: THE EVO-20-25-12.5-E STENT OF UNKNOWN LOT NUMBER WAS UNAVAILABLE FOR EVALUATION. A SECOND FULLY COVERED 10CM ESOPHAGEAL STENT WAS PLACED INSIDE (TO OVERLAP THE EXISTING STENT) TO CAUSE TISSUE NECROSIS FOR THE REMOVAL OF BOTH STENTS IN 2 WEEKS TIME BOTH STENTS HAVE BEEN REMOVED SUCCESSFULLY - NOTHING ELSE TO REPORT. NO FURTHER PROCEDURES REQUIRED RELATED TO THIS. WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. THERE IS NO EVIDENCE TO SUGGEST THAT THIS EVENT DID NOT OCCUR, THEREFORE THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ROOT CAUSE: THERE WAS NO DEVICE RETURNED FOR INVESTIGATION, AND NO IMAGES AVAILABLE FOR REVIEW, THEREFORE A DEFINITE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, AS PER THE INSTRUCTIONS FOR USE, (IFU0090-3), STENT MIGRATION IS LISTED AS A COMPLICATION FOLLOWING THE PLACEMENT OF THIS DEVICE. IFU REVIEW: AS PER THE INSTRUCTIONS FOR USE, IFU0057-5, NOTES SECTION THE USER IS INSTRUCTED OF THE FOLLOWING: ¿VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF ANY ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE". ¿PASSING A SECOND STENT DELIVERY SYSTEM THROUGH A JUST DEPLOYED STENT IS NOT RECOMMENDED AND COULD CAUSE THE STENT TO DISLODGE. TESTING OF OVERLAPPING STENTS HAS NOT BEEN COMPLETED AND IS NOT RECOMMENDED. THIS DEVICE IS NOT INTENDED TO BE DEPLOYED THROUGH THE WALL OF A PREVIOUSLY PLACED OR EXISTING METAL STENT. DOING SO COULD RESULT IN DIFFICULTY OR INABILITY TO REMOVE INTRODUCER.¿ NOTE: THIS COMPLAINT HAS NOT BEEN AFFECTED BY THE DOCTOR PLACING A STENT WITHIN THE FIRST ALREADY MIGRATED STENT BUT IT IS NOT SEEN AS BEST PRACTICE TO DO SO. DOCUMENT REVIEW: PRIOR TO DISTRIBUTION ALL EVO-20-25-12.5-E DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. SUMMARY: THERE IS NO EVIDENCE TO SUGGEST THAT THIS EVENT DID NOT OCCUR, THEREFORE THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. THE STENT WAS REMOVED. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS EVENT. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    AS PER INITIAL NOTIFICATION: FULLY COVERED ESOPHAGEAL STENT WAS PLACED IN THE ESOPHAGUS AND THE STENT MIGRATED TOWARDS THE STOMACH. THE STENT WAS REPOSITIONED BY GRABBING THE STENT LOOP AT THE PROXIMAL END. ANOTHER FULLY COVERED STENT WAS PLACED INSIDE OF THE EXISTING STENT. THE 2ND PROCEDURE CARRIED OUT ON THE (B)(6) 2018. UNKNOWN DETAILS OF THE 1ST STENT PLACED. AS PER COMPLAINT FORM RECEIVED ON 10TH JULY 2018: THE ORIGINAL ESOPHAGEAL STENT WAS PLACED FOLLOWING A PERFORATION IN THE ESOPHAGUS. APPROX 6 WEEKS LATER ON THE (B)(6) 2018 DR ATTEMPTED TO REMOVE THE STENT. THE STENT HAD MIGRATED INTO THE STOMACH AT THE DISTAL END AND THERE WAS TISSUE INGROWTH AT THE PROXIMAL END OF THE STENT MAKING IT NOT POSSIBLE TO REMOVE THE STENT. A SECOND FULLY COVERED 10CM ESOPHAGEAL STENT WAS PLACED INSIDE (TO OVERLAP THE EXISTING STENT) TO CAUSE TISSUE NECROSIS FOR THE REMOVAL OF BOTH STENTS IN 2 WEEKS TIME.

    Description of Event or Problem · 0

    THIS FOLLOW UP REPORT IS BEING SUBMITTED TO PROVIDE THE CONCLUSIONS OF THIS INVESTIGATION TO THE FDA. AS PER INITIAL NOTIFICATION: FULLY COVERED ESOPHAGEAL STENT WAS PLACED IN THE ESOPHAGUS AND THE STENT MIGRATED TOWARDS THE STOMACH. THE STENT WAS REPOSITIONED BY GRABBING THE STENT LOOP AT THE PROXIMAL END. ANOTHER FULLY COVERED STENT WAS PLACED INSIDE OF THE EXISTING STENT. 2ND PROCEDURE CARRIED OUT ON THE (B)(6) 2018. UNKNOWN DETAILS OF THE 1ST STENT PLACED. AS PER COMPLAINT FORM RECEIVED ON 10TH JULY 2018: THE ORIGINAL ESOPHAGEAL STENT WAS PLACED FOLLOWING A PERFORATION IN THE ESOPHAGUS. APPROX 6 WEEKS LATER ON THE (B)(6) 2018 DR ATTEMPTED TO REMOVE THE STENT. THE STENT HAD MIGRATED INTO THE STOMACH AT THE DISTAL END AND THERE WAS TISSUE INGROWTH AT THE PROXIMAL END OF THE STENT MAKING IT NOT POSSIBLE TO REMOVE THE STENT. A SECOND FULLY COVERED 10CM ESOPHAGEAL STENT WAS PLACED INSIDE (TO OVERLAP THE EXISTING STENT) TO CAUSE TISSUE NECROSIS FOR THE REMOVAL OF BOTH STENTS IN 2 WEEKS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569964 EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED ESW PROSTHESIS, ESOPHAGEAL ESW COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention