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

Catalog Number EVO-20-25-15-E

Device Problem Difficult to Open or Close (2921)

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

Event Date 06/08/2015

Event Type  malfunction  

Manufacturer Narrative

This complaint is reportable on the basis of the reporting precedence established for this product family for deployment issue resulting in exposed stent being removed from pt with the delivery system regardless of the pt outcome.This complaint is in relation to an evo-20-25-15-e device of lot number c916932.The complaint issue was reported as follows: "customer had a problem during the deployment of esophageal evolution stent as the stent did not open completely, and still attached to the delivery system after removing the stylet and then he tried step by step to withdraw the system till he got it out and finally he put another one in".Lab eval held: july 22, 2015.On eval of the returned device, it was noted that the stent was returned partially deployed with the stent protruding from the sheath.The stent was manually deployed by the cirl research & development engineer and it was noted that the stent was loaded correctly, and also the stent suture was correct.No issues were noted with the stent.Upon further review of the dismantled device, it was noted that the pert to cannula joint ((b)(4)), and cannula to cannula joint ((b)(4)) had failed.However, the cirl research and development engineer commented that there was evidence of glue present for both joints.A definitive cause for the reported issue was unable to be determined as the actual use conditions could not be duplicated in the lab setting.However, the cirl research & development engineer ((b)(4)) commented that a possible cause of the joints failing could be due to excessive pressure, and force applied to the device.Another possible cause may have been that it was a tortuous anatomy.The customer complaint was confirmed as the cannula to cannula joint had failed.A review of the mfg records for the evo-20-25-15-e device of lot number c916932 revealed no discrepancies that could have contributed to this complaint issue.A pert to cannula compression test was completed on a rep sample of the batch and no issues were noted.Prior to distribution all evo-20-25-15-e devices are subjected to a visual inspection and functional checks to ensure device integrity.There is a specific production check as per (b)(4) to deploy the stent approx 50% and recapture it to ensure it functions correctly.Pt outcome was requested, but has not been provided to date.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Customer had a problem during the deployment of esophageal evolution stent as the stent did not open completely and still attached to the delivery system after removing the stylet.He then tried step by step to withdraw the system till he got it out and finally he put another one in.This relates to report# 3001845648-2015-00135.

• Brand Name: EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED
• Type of Device: ESW PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): COOK IRELAND LTD; limerick ; EI
• Manufacturer Contact: sinead guaid, sr, specialist ; EI ; 61334440
• MDR Report Key: 4962046
• MDR Text Key: 22675429
• Report Number: 3001845648-2015-00152
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: K080359
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Report Date: 07/22/2015

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 Expiration Date: 08/19/2015
• Device Catalogue Number: EVO-20-25-15-E
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/06/2015
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/22/2015
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/31/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2013
• 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