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

Catalog Number	EVO-20-25-10-E
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/21/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information was requested, however as per response received ¿the sales rep has no further information about this event.¿ the device involved in this complaint was not returned to cook (b)(4) for evaluation.As the device has not been returned, 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 testimony.Prior to distribution, all evo-20-25-10-e devices are subject 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 c1136306 revealed no discrepancies that could have contributed to this complaint issue.As per the instructions for use, stent migration is a known additional complication.As per information provided, the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for emerging trends.
Event or Problem Description
This procedure was the first case for this user to use evolution esophageal controlled-release stent - partially covered.He placed the stent at the target site but it migrated into the stomach.He removed the migrated stent using tube/catheter through the mouth and placed another evolutionesophageal controlled-release stent - partially covered at the target site successfully.

• Brand Name: EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED
• Common Device Name: ESW PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5566783
• Report Number: 3001845648-2016-00088
• Device Sequence Number: 247547
• Product Code: ESW
• UDI-Device Identifier: 10827002480312
• UDI-Public: (01)10827002480312(17)170730(10)C1136306
• Combination Product (Y/N): N
• 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): 03/14/2016

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?: No
• 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: 01/21/2016
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2016
• Initial Report FDA Received Date: 04/11/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention