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

Catalog Number EVO-FC-R-20-25-12-E

Device Problem Activation Failure (3270)

Patient Problem Surgery, prolonged (2177)

Event Date 09/18/2014

Event Type  Injury  

Event Description

During a live endoscopy course ((b)(6) live), prof.(b)(6) was placing an evo-fc-r-e in a pt.This first stent was not successfully placed.Reference mdr report # 3001845648-2014-00224 for details.Prof.(b)(6), repeated the procedure with a new evo-fc-r-e.After deployment of the new stent and prior to removal of the system he viewed the stent under endoscopic visualization.He noted the sutures in the newly placed stent were preventing the stent from opening.He negotiated the introducer out of the stent and then finished the procedure by expanding the stent that remained in the patient using the hercules dilation balloon.No adverse effects to the patient have been reported as occurring as a result of this incident.

Manufacturer Narrative

This device is not registered for sale in the united states.However, indication for use has been confirmed as malignant.Therefore this device is considered 'similar' to other metal stent/sets (evolution) devices currently marketed in the united states based on this malignant indication.Note confirmation of this malignant indication was received on 10/14/2014; initial complaint details received had reported the indication for use as benign.Similar metal stent/sets (evolution) are currently marketed in the united states under the following 510(k) #: k093619, k080359, k101530, k113510, k121430.Fda mdr reporting required based on the action of the physician to dilate the unexpanded stent.A reporting precedence also exists for this product family for the stent not expanding.The device was not available to be returned as it was implanted in the pt.With the info provided a document based investigation was carried out.A possible cause of the stent not releasing could be if the stent crown had become caught between the bi lumen and pert collar.However, as the device was not available for evaluation we cannot conclusively determine the cause of this complaint.The customer complaint could be confirmed based on customer testimony.Prior to distribution all evo-fc-r-20-25-12-e devices are subjected to functional checks and visual inspection to ensure integrity of the product.As per relevant production instruction, there is a specific check to deploy the stent approx 50% and recapture it to ensure it functions correctly.As per instructions for use, it states: "if package is opened or damaged when received, do not use.Visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use." there were no adverse affects to the pt reported as a result of this occurrence.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: sinead quaid, sr. specialist ; 61334440
• MDR Report Key: 4254397
• MDR Text Key: 21330282
• Report Number: 3001845648-2014-00225
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/29/2016
• Device Catalogue Number: EVO-FC-R-20-25-12-E
• Device Lot Number: C1023109
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/18/2014
• Event Location: Hospital
• Date Manufacturer Received: 10/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2014
• 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