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	07/15/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The 1 x evo-20-25-15-eof lot number c1032209 was returned for evaluation.Upon evaluation of the returned device, it was noted that the lockwire was returned with the device and the stent was returned fully deployed.There are 2 crowns overlapping on the stent.The lasso loops were displaced, therefore, the stent failed to open fully.The customer complaint was confirmed as the lasso loops were displaced not allowing the stent to open fully.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 review of the manufacturing records for the evo-20-25-15-e device of lot number c1032209 revealed no discrepancies that could have contributed to this complaint issue.There is no evidence to suggest that this issue affects the entire lot # c1032209; upon review of complaints this failure mode has not occurred previously with this lot # c1032209.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
Information initially received indicated the evolution stent failed to deploy.Note the stent was returned fully deployed with displaced lasso loops.Additional information relating to this complaint has been requested but to date clarification has not been received.Fda mdr reportable based upon a reporting precedence established for this device family.

• 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: 5899593
• Report Number: 3001845648-2016-00226
• Device Sequence Number: 696241
• Product Code: ESW
• UDI-Device Identifier: 10827002480336
• UDI-Public: (01)10827002480336(17)160902(10)C1032209
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 07/28/2016

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: 07/15/2016
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2016
• Initial Report FDA Received Date: 08/24/2016
• Patient Sequence Number: 1