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

Catalog Number EVO-20-25-10-E

Device Problem Difficult to Open or Close (2921)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/13/2015

Event Type  malfunction  

Manufacturer Narrative

This complaint is reportable to the fda on the basis of the reporting precedence established for this product family for ¿stent not expanding' regardless of the patient outcome.The complaint was reported as follows: customer wants to inform that proximal flange won¿t open ideally because the white thread is stretched on one side.As per complaint form: "customer would like to inform you that the proximal flange of the stent won¿t open ideally, because of the white thread is on one side very stretched.Doctor loosened the thread with a forceps." a section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The device has not been returned for evaluation therefore a document based investigation has been carried out.The cause of the complaint could not be conclusively determined.The customer complaint has been confirmed based on customer testimony.Further feedback from the complaining site through the rep was received as follows: ¿you asked me about the complaint with the esophageal evolution.Prof.(b)(6) said that both bands (white and green) seemed to be very twirled and guessed that this would be the reason for the non-exact expansion of the stent.The white band seemed under tension at one point and was loosened with a grasping forceps a little bit".Pictures provided showed the tension directly after implantation.Picture one has been taken after loosening the white band.The stent has been placed perfectly, no repositioning needed.Prior to distribution all evo-20-25-10-e devices are subjected to visual inspection and functional checks to ensure device integrity.These inspections are outlined in internal procedures in place at cirl.A review of the relevant manufacturing records revealed no discrepancies related to this complaint issue.The component stent as supplied by the vendor, when received at cook (b)(4), is subjected to incoming inspection.A review of the incoming quality control records for the relevant component lot did not reveal any discrepancies which could have contributed to this complaint issue.As per incoming quality control procedures the stent is 100% inspected and functionally tested for compliance to the specified drawings.This failure mode is also considered in the risk document ¿potential failure mode: stent doesn¿t open to the correct size¿, with the ¿potential causes of failure: loop interferes with stent opening.¿ design verification testing has been carried out and completed as a control for this failure mode.It was noted in the complaint that ¿the patient did not experience any adverse effects due to this occurrence.The patient did not require any additional procedures due to this occurrence.The stent is well placed.¿ complaints of this nature will continue to be monitored for potential emerging trends.This complaint is reportable to the fda on the basis of the reporting precedence established for this product family for ¿stent not expanding' regardless of the patient outcome.The complaint was reported as follows: customer wants to inform that proximal flange won¿t open ideally because the white thread is stretched on one side.As per complaint form: "customer would like to inform you that the proximal flange of the stent won¿t open ideally, because of the white thread is on one side very stretched.Doctor loosened the thread with a forceps." a section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence the device has not been returned for evaluation therefore a document based investigation has been carried out.The cause of the complaint could not be conclusively determined.The customer complaint has been confirmed based on customer testimony.Further feedback from the complaining site through the rep was received as follows: ¿you asked me about the complaint with the esophageal evolution.Prof.(b)(6) said that both bands (white and green) seemed to be very twirled and guessed that this would be the reason for the non-exact expansion of the stent.The white band seemed under tension at one point and was loosened with a grasping forceps a little bit".Pictures provided showed the tension directly after implantation.Picture one has been taken after loosening the white band.The stent has been placed perfectly, no repositioning needed.Prior to distribution all evo-20-25-10-e devices are subjected to visual inspection and functional checks to ensure device integrity.These inspections are outlined in internal procedures in place at cirl.A review of the relevant manufacturing records revealed no discrepancies related to this complaint issue.The component stent as supplied by the vendor, when received at cook (b)(4), is subjected to incoming inspection.A review of the incoming quality control records for the relevant component lot did not reveal any discrepancies which could have contributed to this complaint issue.As per incoming quality control procedures the stent is 100% inspected and functionally tested for compliance to the specified drawings.This failure mode is also considered in the risk document ¿potential failure mode: stent doesn¿t open to the correct size¿, with the ¿potential causes of failure: loop interferes with stent opening.¿ design verification testing has been carried out and completed as a control for this failure mode.It was noted in the complaint that ¿the patient did not experience any adverse effects due to this occurrence.The patient did not require any additional procedures due to this occurrence.The stent is well placed.¿ complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Customer wants to inform that proximal flange wont open ideally because the white thread is stretched on one side.As per complaint form, the customer would like to inform you that the proximal flange of the stent wont open ideally, because of the white thread is on one side very stretched.Doctor loosened the thread with a forceps.The stent is well placed.

• Brand Name: EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED
• Type of Device: ESW PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick ; EI
• Manufacturer Contact: sinead quaid ; o'halloran road; national technology park; limerick ; EI ; 061334440
• MDR Report Key: 5072956
• MDR Text Key: 26121419
• Report Number: 3001845648-2015-00171
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• PMA/PMN Number: K080359
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Report Date: 08/14/2015

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
• Device Operator: Health Professional
• Device Catalogue Number: EVO-20-25-10-E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/13/2015
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1