MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT -FULLY COVERED; ESW PROSTHESIS, ESOPHAGEAL

Catalog Number EVO-FC-20/25-10-E

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Migration (2249)

Event Date 11/28/2013

Event Type  Injury  

Event Description

On the (b)(6) 2013, a hanaro anti reflux stent was placed across the goj, after successful chemotherapy this stent then migrated into the stomach and the pt represented.On the (b)(6) 2013, the hanaro stent was not removed from the stomach and a new esophageal stent was placed, (cook fullycovered 10x20).Chemotherapy was continued and subsequently the cook stent also migrated into the stomach.The info received indicated the pt was scheduled for a colonoscopy to remove the cook stent.If this is unsuccessful then full surgery will be required.Info concerning the outcome of the colonoscopy was requested but not available as the pt had moved hospitals and could not be tracked by the original physician.

Manufacturer Narrative

This complaint report meets the reporting criteria of an fda mdr report based on the scheduled intervention (colonoscopy) to remove the migrated stent.The actual lot number of the evo-fc-20-25-10-e device involved in this complaint was not provided.As the lot number was not provided 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 stent was not available to be returned as it was implanted in the pt.Images were provided.With the info provided a document based as it was implanted in the pt.Images were provided.With the info provided a document based investigation was carried out.On the (b)(6) 2013, a hanaro anti reflux stent was placed across the goj, after successful chemotherapy this stent then migrated into the stomach and the pt represented.On the (b)(6) 2013, the hanaro stent was not removed from the stomach and a new esophageal stent was placed, (cook fullycovered 10x20).Chemotherapy was continued and subsequently the cook stent also migrated into the stomach.The info received indicated the pt scheduled for a colonoscopy to remove the cook stent.If this is unsuccessful then full surgery will be required.Info concerning the outcome of the colonoscopy was requested but not available as the pt had moved hospitals and could not be tracked by the original physician.From the complaint description received chemotherapy was continued after stent placement.Input received from the relevant product specialist indicated the insertion of this type of stent is usually delayed until all chemo/radiotherapy is complete, as this treatment shrinks the tumor and may result in the stent migrating.Further clinical opinion received confirmed the chemotherapy administered could have affected the stricture enough to allow/promote migration.As per the instructions for use, precautions section the user advised as follows: "after stent placement, alternative methods such as chemotherapy and radiation should not be administered as this may increase the risk of stent migration due to tumor shrinkage, stent erosion and/or mucosa bleeding.A review of the provided images relating to this complaint confirmed the initial placement of the evo stent looked good, slightly proximal, but the stricture is between the flanges and within the body of the stent.The images provided also clearly show that the evo stent has migrated and entered the colon.Based on the imaging review, stent migration could be confirmed.The pt was continued in their course of treatment of chemotherapy following stent placement.The ifu states "after stent placement.Chemotherapy.Should not be administered as this may increase risk of stent migration.Stent misplacement and stent migration are known potential complications that can occur in conjunction with upper gi endoscopy as per instructions for use, ifu.A review of the mfg records for evo-fc-20-25-10-e devices could not be carried out as the lot number was not provided.Prior to distribution evolution devices are subjected to a visual inspection and functional checks to ensure device integrity.From the info provided, the pt is set for colonoscopy to remove the stent; however, info concerning the colonoscopy is not available as the pt has moved hospitals.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT -FULLY COVERED
• Type of Device: ESW PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): COOK IRELAND LTD; limerick ; EI
• Manufacturer Contact: tracy o'sullivan ; 61334440
• MDR Report Key: 3641494
• MDR Text Key: 4280902
• Report Number: 3001845648-2014-00025
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K093619
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 01/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EVO-FC-20/25-10-E
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/28/2013
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/20/2014
• Initial Date FDA Received: 02/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR