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

Catalog Number	EVO-FC-18-23-10-E
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 upon evaluation of the returned device, it was noted that the stent was fully deployed on return; it was still on delivery system.The lockwire was not removed from the system.The peek was almost broken which is assumed to have occurred on pulling the device out from the patient or on return.The device was noted to have been manufactured correctly.The lockwire had not been pulled out fully to release the stent from the system.The customer complaint was confirmed as the stent was still attached to the system fully deployed, however, it may be noted that user error was indicated as the lockwire was not released.Product manager has been notified of this complaint to contact rep to provide customer with training.Prior to distribution all evo-fc-18-23-10-e devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.As per the instructions for use which accompanies the device, states the following: ¿when stent point-of-no-return has been passed, pull safety wire out of delivery near wire guide port.¿ a review of the manufacturing records for this evolution device of lot c1183369 revealed no discrepancies that could have contributed to this complaint issue.From the information provided, there have been no adverse effects to the patient as a result of this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
Additional information received on the 18-apr-2017 that the stent was not fully retracted on removal from the patient.This initial mdr is being submitted based on the malfunction precedence of 'deployment issue that results in the exposed stent removed from the patient with the delivery system'.As reported to customer relations: "the physician deployed but would not release from deployment device.Removed the device from the patient and used a boston scientific stent to complete the procedure.".

• Brand Name: EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT -FULLY COVERED
• Common Device Name: ESW PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 6568452
• Report Number: 3001845648-2017-00174
• Device Sequence Number: 18966148
• Product Code: ESW
• UDI-Device Identifier: 10827002511825
• UDI-Public: (01)10827002511825(17)171216(10)C1183369
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K093619
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/18/2017

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-FC-18-23-10-E
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/18/2017
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2017
• Initial Report FDA Received Date: 05/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1