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

Catalog Number	EVO-20-25-10-E
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/30/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Images were provided to aid in the investigation.The research & development engineer reviewed the images and provided the following comments: "the pictures show the distal end of the delivery system and the stent.There is no evidence of damage to the delivery system in the photos.There is a space between the collar and bilumen.Also, the stent lasso loop looks ok." as the device was not returned for evaluation; therefore the cause of this complaint could not be conclusively determined.With the information provided a document based investigation was carried out.The customer complaint is considered to be confirmed based on customer testimony and images provided.Prior to distribution all evo-20-25-10-e devices are subjected to visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at (b)(4).A review of the manufacturing records for the evo-20-25-10-e device of lot number c1229993 revealed no discrepancies that could have contributed to this complaint issue.Information provided indicates that the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
The trigger was fired to the end and the security thread was removed as per instructions for use.The prosthesis was in the desired location for release and opening normally.When removing the device the prosthesis does not detach.

• Brand Name: EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED
• Common Device Name: ESW PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 6105265
• Report Number: 3001845648-2016-00327
• Device Sequence Number: 89448
• Product Code: ESW
• UDI-Device Identifier: 10827002480312
• UDI-Public: (01)10827002480312(17)180509(10)C1229993
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K080359
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 10/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: EVO-20-25-10-E
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/30/2016
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2016
• Initial Report FDA Received Date: 11/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1