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

Catalog Number EVO-20-25-12.5-E

Device Problem Delivery System Issue, No Description (2664)

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

Event Date 05/30/2014

Event Type  malfunction  

Event Description

The following complaint information was provided by the user: the stricture was marked in the oesophagus and the stent was placed as per the ifu.After the slow removal of the introducer system post stent deployment, the stent appeared out of the patients mouth.There was no resistance noticed upon removal of the delivery system and the lock wire was fully removed from the patient.Another evo stent was then placed to successfully finish the procedure.No adverse effects to the patient reported as occurring.

Manufacturer Narrative

There were no evo-20-25-12.5-e (evolution) devices of lot c982381 in stock at the time of the investigation.On evaluation of the returned device, it was noted that the stent was returned fully deployed and released from the delivery system.The lock wire was not returned with the device.The returned fully deployed stent did not appear to be damaged.There was no crown or suture damage noted.On examination of the pert and bilumen of the introduction system, it was confirmed that they were touching each other as per specification.Minor damage was observed to the pert at the point where it made contact with the bilumen.No other issues were noted and the device appeared to be manufactured as per specification.A possible cause of the damage to the pert and the difficulty the customer experienced in releasing the stent from the introduction system could be if some of the stent crowns were grasped between the pert and bilumen.If a crown became stuck between the pert and bilumen, it would not be possible to release the stent from the introduction system.However, as actual use conditions cannot be replicated in the laboratory, we are unable to conclusively determine the cause of this complaint.The customer complaint is considered confirmed based on customer testimony.The component involved in this complaint is the esophageal stent.A review of the incoming quality control records for the stent component used in lot c982381 did not reveal any discrepancies which could have contributed to this complaint issue.Prior to distribution evolution devices are subjected to a visual inspection and functional checks to ensure device integrity.A review of the manufacturing records for evo-20-25-12.5-e of lot c982381 did not reveal any discrepancies that could have contributed to this issue.As per the instructions for use, ifu0061-4, this device is used to maintain patency of malignant esophageal strictures and/or to seal tracheoesophageal fistulas.The stent is not intended to be removed and is considered a permanent implant.Attempts to remove stent after placement may cause damage to esophageal mucosa.As per the instructions for use, ifu0061-4, the user is instructed of the following: step 4 "confirm desired stent position fluoroscopically and deploy stent by removing the red safety guard from the handle.Step 5 continue deploying stent by squeezing trigger.Note: each trigger squeeze will deploy stent by an equal amount.Step 10 when stent point-of-no-return has been passed; pull safety wire out of delivery handle near wire guide port.Step 11 continue deploying stent by squeezing trigger.Step 12 after deployment, fluoroscopically confirm stent expansion.Once full expansion is confirmed, introduction system can be safety removed." from the information provided, the patient did not experience any adverse effects due to this occurrence.The procedure was successfully completed with another stent.Complaints of this nature will continue to be monitored for potential emerging trends.

• 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: tracy o'sullivan ; EI ; 61334440
• MDR Report Key: 3966401
• MDR Text Key: 19922346
• Report Number: 3001845648-2014-00112
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: GB
• 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
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 05/30/2014

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: 03/31/2016
• Device Catalogue Number: EVO-20-25-12.5-E
• Device Lot Number: C982381
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/10/2014
• Distributor Facility Aware Date: 05/30/2014
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/03/2014
• Initial Date FDA Received: 06/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 58 YR