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); Activation Failure (3270)

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

Event Date 11/04/2014

Event Type  malfunction  

Event Description

The doctor attempted to place an evolution stent in the esophagus of a patient with a malignant tumor.The proximal end of the stent would not fully expand.When the delivery system was removed, the stent was pulled out with it.The cook ref examined the stent benchtop and noted that it was very difficult to expand the stent at all.The doctor opened another stent and was able to place it successfully.No adverse effects to the patient have been reported as occurring as a result of this event.

Manufacturer Narrative

Incident requires fda mdr reporting based on the reporting precedences established for this product family for 'stent not expanding' and 'removal of a permanent stent [deployment related]; regardless of patient outcome.To date, the device involved in this complaint has not been returned for evaluation.With the information provided a document based investigation was carried out.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.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 evolution devices are subjected to a visual inspection and functional checks to ensure device integrity.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." from the information provided the patient did not experience any adverse effects due to this occurrence.The stent was removed with the introducer and the doctor placed another stent successfully.Complaints of this nature will continue to be monitored for 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: sinead quaid, sr. specialist ; EI ; 61334440
• MDR Report Key: 4320876
• MDR Text Key: 5242854
• Report Number: 3001845648-2014-00297
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: Other
• Type of Report: Initial
• Report Date: 11/04/2014

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 Catalogue Number: EVO-20-25-15-E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/04/2014
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/11/2014
• Initial Date FDA Received: 12/02/2014
• 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