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 Consequences Or Impact To Patient (2199)
Date of Event	10/28/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the device has not yet been returned for evaluation; the cause of this complaint could not be conclusively determined.A follow-up report will be submitted on receipt of the device to include the device evaluation.With the information provided a document based investigation was carried out.The customer complaint is considered to be confirmed based on customer testimony.A review of the manufacturing records for this evo-20-25-15-e device of lot c1150439 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 cirl.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
Stent was being deployed, then was retracted to reposition.Stent would not retract properly with some of the stent being visible after retraction.Endoscope and stent removed from patient as procedure could not continue with cook stent.Endoscope inserted back into patient and a new stent from another supplier was used to complete procedure.A malfunction precedence exists for a deployment issue that results in an exposed stent being removed from the patient with the delivery system.
Additional Manufacturer Narrative
On evaluation of the returned device, it was noted that no lockwire was in place or returned.The red shuttle was fully forward on the device indicating that they tried to recapture the stent to reposition it when the lockwire was removed-user error.¿stent would not retract properly with some of the stent being visible after retraction.¿ it would not be possible to retract the stent when the lockwire was pulled.Research and development engineer demonstrated this during the lab evaluation then deployed the stent fully to show that there were no issues with the stent the customer complaint was confirmed as retraction was not possible during evaluation, however, as stated by the research and development engineer retraction would not be possible once the lockwire had been pulled.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 cirl.As per the instructions for use that accompanies this device: ¿when stent point-of-no-return has been passed, pull safety wire out of delivery handle near wire guide port." from the information provided, there have been no adverse effects to the patient as a result of this occurrence.
Event or Problem Description
A follow-up mdr is being submitted to include the device evaluation details.Stent was being deployed, then was retracted to reposition.Stent would not retract properly with some of the stent being visible after retraction.Endoscope and stent removed from patient as procedure could not continue with cook stent.Endoscope inserted back into patient and a new stent from another supplier was used to complete procedure.A malfunction precedence exists for a deployment issue that results in an exposed stent being removed from the patient with the delivery system.

• 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: 6131639
• Report Number: 3001845648-2016-00341
• Device Sequence Number: 812652
• Product Code: ESW
• UDI-Device Identifier: 10827002480336
• UDI-Public: (01)10827002480336(17)170915(10)C1150439
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2016

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: 10/28/2016
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/01/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/29/2016
• Supplement Report FDA Received Date: 12/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1