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

Catalog Number	EVO-20-25-15-E
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/17/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon evaluation of the returned device it was noted that the safety wire was not present in the device, but was returned separately.The stent was returned fully deployed from the system.No issue was noted with the stent.The sutures were examined and were ok.A kink was noted 3mm between the pert and the bilumen.There was also a kink evident 50mm from the pert to the peak kink.It is unknown when these kinks occurred.However, the (b)(4) research & development engineer commented that the kinks would not have been related to the issue experienced by the user.The position the device was returned in would indicate that full deployment had occurred.Actuation of the handle was possible.A definitive cause for the customer¿s complaint was unable to be determined because the actual use conditions could not be duplicated in the laboratory setting.A request for images was submitted.No response has been received to date.The customer complaint was confirmed based on the customers testimony as the failure could not be replicated.A review of the manufacturing records for the evo-20-25-15-e device of lot number c1184275 revealed no discrepancies that could have contributed to this complaint issue.Prior to distribution all evo-20-25-15-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 (b)(4).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 evolution stent couldn't be released - even with the safety wire pulled.When the user removed the introducer the fully expanded stent was also removed out of the patient.

• 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: 5570344
• Report Number: 3001845648-2016-00092
• Device Sequence Number: 16264893
• Product Code: ESW
• UDI-Device Identifier: 10827002480336
• UDI-Public: (01)10827002480336(17)171217(10)C1184275
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 03/17/2016

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-20-25-15-E
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/17/2016
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2016
• Initial Report FDA Received Date: 04/12/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1