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

Catalog Number EVO-20-25-15-E

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Surgical procedure, delayed (2565)

Event Date 10/10/2014

Event Type  Injury  

Event Description

The evolution stent did not deploy correctly.It started off with a good position.When the doctor went to deploy the stent all was going fine until it was time to remove everything and the stent ended up in the pts' throat; it had detached itself from the delivery system.The stent was eventually removed with a grasping forceps.Additional info received indicated it is unk for sure if the doctor had waited for the stent to open properly before they removed the delivery system from the pt, but that the delivery system was removed quickly making it possible it snagged the stent and pulled it up.No further adverse effects to the pt have been reported.No part of the device remains in the pt.

Manufacturer Narrative

To date, the device involved in this incident has not been returned for eval.With the info provided a document based investigation was carried out.The complaint info reported was as follows: the evolution stent did not deploy correctly.It started off with a good position.When the doctor went to deploy the stent all was going fine until it was time to remove everything and the stent ended up in the pts' throat; it had not detached itself from the delivery system.The stent was eventually removed with a grasping forceps.Additional info received indicated it is unk for sure if the doctor had waited for the stent open properly before they removed the delivery system from the pt, but that the delivery system was removed quickly making it possible it snagged the stent and pulled it up.The customer complaint could be confirmed based on customer testimony.As the device has not been received; therefore, the cause of this complaint could not be conclusively determined.Prior to distribution evolution devices are subjected to a visual inspection and functional checks to ensure device integrity.A review of the mfg records for evo-20-25-15-e of lot c1016921 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, instructs the user 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 full stent expansion.Once full expansion is confirmed introduction system can be safely removed".No further adverse effects to the pt have been reported.The stent was successfully removed from the pts throat.No part of the device remains in the pt.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.

• Brand Name: EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT-PARTIALLY COVERED
• Type of Device: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): COOK IRELAND LTD; limerick ; EI
• Manufacturer Contact: sinead quaid, sr reg aff splist ; 61334440
• MDR Report Key: 4254863
• MDR Text Key: 15915925
• Report Number: 3001845648-2014-00223
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Nurse
• Type of Report: Initial
• Report Date: 10/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/04/2016
• Device Catalogue Number: EVO-20-25-15-E
• Device Lot Number: C1016921
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/10/2014
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/14/2014
• Initial Date FDA Received: 11/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/04/2014
• 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
• Patient Outcome(s): Required Intervention