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	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/21/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been received; 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 was confirmed based on the customer¿s testimony.Prior to distribution all evo-20-25-10-e devices are subjected to a visual inspection and functional checks to ensure device integrity.A review of the manufacturing records for the evo-20-25-10-e device of lot number c1215702 revealed no discrepancies that could have contributed to this complaint issue.There is no evidence to suggest that this issue affects the entire lot # c1215702; upon review of complaints this failure mode has not occurred previously with this lot # c1215702.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
After placement of the wire guide into the stomach without problem, the endoscope is now out and the user started to deploy the evolution stent with no issues.The safety wire (at the point of no return) was pulled out but not fully (15 cm).The distal part of the stent is deployed but the proximal part of the stent did not look like it deployed well.The doctor decided to remove the whole system.Out of the body, they saw that the stent was still fixed to the catheter.The doctor left the wire guide in the patient and placed another evo-20-25-10-e with success.

• 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: 5807981
• Report Number: 3001845648-2016-00185
• Device Sequence Number: 416489
• Product Code: ESW
• UDI-Device Identifier: 10827002480312
• UDI-Public: (01)10827002480312(17)180329(10)C1215702
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 06/23/2016

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: 06/21/2016
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2016
• Initial Report FDA Received Date: 07/20/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1