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 Codes	Migration or Expulsion of Device (1395); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/09/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in this complaint was not returned to cook ireland for evaluation.With the information provided a document based investigation was carried out.The following comments were provided by research & development engineer: ¿from the information provided below, the tip interacted with the stent causing the stent to dislodge.There are controls in the ifu to prevent this occurring: dilate stricture to a minimum size as outlined in the precautions section¿ after deployment, fluoroscopically confirm full stent expansion.Once full expansion is confirmed, introduction system can be safely removed.Do you know if these steps were performed? if not, it would suggest misuse.¿ the following questions were requested but no information has been provided: ¿can you confirm with the rep if the following steps were taken: dilate stricture to a minimum size.After deployment, fluoroscopically confirm full stent expansion.¿ the customer complaint was not confirmed.This complaint was deemed off-label use.Prior to distribution all evo-20-25-15-e devices are subjected to visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.A review of the manufacturing records for the evo-20-25-15-e device of lot number c1136307 revealed no discrepancies that could have contributed to this complaint issue.As per the instructions for use, ifu0061-5, additional complications include, but are not limited to: stent misplacement and/or migration.Also: ¿after deployment, fluoroscopically confirm full stent expansion.Once full expansion is confirmed, introduction system can be safely removed.¿ 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 potential emerging trends.
Event or Problem Description
The user attempted to place evo-20-25-15-e inside an 8cm bare stent previously placed in the esophagus.He aligned the distal end of the evo stent at the distal end of the 8cm bare stent, and deployed the stent as extending to the proximal side.However, it was 'stent-in-stent', so the evo stent was not appressed to the esophagus wall.The evo stent migrated to the proximal side because the delivery system tip caught the evo stent during removal.Stenting became longer than the user planned, so he removed the evo stent using a grasping forceps and placed a 12.5cm stent successfully to complete the procedure.

• 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: 5942546
• Report Number: 3001845648-2016-00235
• Device Sequence Number: 13830284
• Product Code: ESW
• UDI-Device Identifier: 10827002480336
• UDI-Public: (01)10827002480336(17)170729(10)C1136307
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 08/09/2016

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-20-25-15-E
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/09/2016
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2016
• Initial Report FDA Received Date: 09/12/2016
• 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