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 Problems Activation, Positioning or Separation Problem (2906); Difficult to Open or Close (2921)

Patient Problems Foreign body, removal of (2365); No Known Impact Or Consequence To Patient (2692)

Event Date 06/08/2015

Event Type  malfunction  

Event Description

Customer had a problem during the deployment of an esophageal evolution stent as the stent did not open completely, and was still attached to the delivery system after removing the stylet.He then tried step by step to withdraw the system until fully removed and another device was used to complete the procedure.

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 patient with the delivery system" regardless of the patient outcome.This complaint is in relation to an evo-20-25-15-e device of an unknown lot number.The device was not returned for evaluation; therefore a document based investigation was carried out.The customer complaint could be confirmed based on the customers testimony and photographs provided.As the device was not returned for evaluation it is not possible to determine the root cause of the deployment difficulty the user experienced.A review of the relevant manufacturing records for evo-20-25-15-e device could not be performed as the lot number of the complaint device was not provided.Prior to distribution all evo-20-25-15-e devices are subjected to a visual inspection and functional checks to ensure device integrity.Patient outcome was requested but was not provided.Complaints of this nature will continue to be monitored for potential emerging trends.

Manufacturer Narrative

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 not opened 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 went out and finally he put another one." lab evaluation held july 22, 2015.On evaluation 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 (b)(4) 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 (through (b)(4)) had failed.However, the (b)(4) research & 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 laboratory setting.However the (b)(4) 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 pert to cannula joint had failed.A review of the manufacturing 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 representative 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 prd0360 to deploy the stent approximately 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

This follow up report is being submitted due to the receipt and evaluation of the complaint device.Initial complaint description received is as follows 'during the deployment of an esophageal evolution device, the stent did not open completely and was still attached to the delivery system after removing the stylet.He withdrew the system and fully removed it from the patient.Another device was used to complete the procedure." this relates to report 3001845648-2015-00152.

• 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 quaid, senior specialist ; 61334440
• MDR Report Key: 4901612
• MDR Text Key: 6066114
• Report Number: 3001845648-2015-00135
• 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: Health Professional,User Facility,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2015
• 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
• Device Lot Number: C916932
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/06/2015
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/08/2015
• Event Location: Hospital
• Date Manufacturer Received: 06/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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