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

Catalog Number EVO-FC-20-25-10-E

Device Problem Off-Label Use (1494)

Patient Problem Failure of Implant (1924)

Event Date 11/30/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

"vedantum et al 2020 evolution (20 mm × 25 mm × 10 cm) endoscopic stents in the management of bariatric complications: our algorithm and outcomes.Stent migration: as per paper, ¿stent migration occurred in 7/35 patients and in 8/51 stents placed (15.7%).¿ ¿stent migration occurred in seven patients (20%) and in eight of 51 stents placed (15.7%).Two patients ultimately required revision surgery, though only one was related to stent (2.9%).¿ (b)(4) (cirl ref #) will capture the 1 case of stent migration which lead to peritonitis.This report will capture the other 7 stents that migrated mentioned in the paper rpn used: please note as stated in the paper: 'fully covered self-expandable metallic stents were used exclusively.Based on institutional availability, either cook evolution (20 mm × 25 mm × 10 cm) or boston scientific wallflex (23 mm × 28 mm × 12.5 cm or 23 mm × 28 mm × 15.5 cm) fully covered esophageal stents were used.' it cannot be confirmed of the overall 51 stents placed across a cohort of 35 patients, which were cook stents, this file is created to capture the potential that it could have been a cook evolution stent.The cook evolution fully covered esophageal stent comes into two versions and based on the dimensions provided above, the two possible rpns used in this paper are as follows: version 1 - evo-fc-20-25-10-e - for use in malignant indications.Version 2 - evo-fc-r-20-25-10-e - for use in benign indications.However, version 2 - evo-fc-r-20-25-10-e is not currently nor has it ever been registered for sale in the us and this study took place in the us.The rpn used in this complaint has been determined to be version 1 - evo-fc-20-25-10-e.41stents were used off label in 35 patients: as per the ifu the evo-fc-20-25-10-e is intended to be used to maintain patency of malignant esophageal strictures and/or to seal tracheoesophageal fistulas.The ifu also states 'the stent is not intended to be removed and is intended to remain in the body permanently.' this paper outlines that of the 35 patients in the study, 41 stents were placed to treat complications related to bariatric surgery including staple line leaks, anastomotic leaks, strictures, marginal ulcer perforations, gastrogastric fistula, and lap band erosion repairs.These are not malignant indications as confirmed by clinical advisor.As per the paper, it states that 'stents were removed after 20 - 30 days' - this is also off label use as confirmed by our clinical advisor.

Manufacturer Narrative

Device evaluation: the evo-fc-20-25-10-e device of unknown lot number involved in this complaint was not available for evaluation.With the information provided, a document based investigation was conducted.This file was created from the attached journal article to capture ¿stent migration¿.Additional complaint file (b)(4) was opened as a result of this paper to capture the¿peritonitis¿.Reference "vedantum 2020." document review including ifu review: as the evo-fc-20-25-10-e device is from unknown lot number, a review of the relevant manufacturing records cannot be conducted.Prior to distribution, all evo-fc-20-25-10-e devices are subjected to functional checks and visual inspection to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.The instructions for use (ifu0061-7) instructs the user to" this device is used to maintain patency of malignant esophageal strictures and/or to seal tracheoesophageal." the instructions for use informs the user about the potential complications " additional complication include, but are not limited to: stent misplacement and/or migration; tumor ingrowth or overgrowth; esophageal ulceration and erosion; nausea; chest or retrosternal pain; foreign body sensation; food bolus impaction; gasbloat; sensitivity to metal components; fistula involving trachea, bronchi or pleural space; intestinal obstruction secondary to migration; mediastinitis or peritonitis; airway compression; tracheal obstruction." there is evidence to suggest that the customer did not follow the instructions for use.As per product manager "if i look at the vedantum study, the off label use is because they used the stent for different intended uses from the one described in our ifu.If they had placed the stents only in the esophagus, the altered anatomy wouldn¿t have influenced the scope insertion like in the biliary scenario.(there is also nothing against this in our ifu) " root cause review: a definitive root cause could be determined from the available information.From the journal article it is known that the user used the device off-label.As per product manager "the off label use is because they used the stent for different intended uses from the one described in our ifu." summary: complaint is confirmed based on the customer's testimony.According to the initial reporter, the patient outcome is unknown.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental report is being submitted due to the completion of the investigation.

• Brand Name: EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT -FULLY COVERED
• Type of Device: ESW PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 10404673
• MDR Text Key: 241137577
• Report Number: 3001845648-2020-00499
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• PMA/PMN Number: K093619
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/07/2021

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-FC-20-25-10-E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/30/2019
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/16/2020
• Initial Date FDA Received: 08/13/2020
• Supplement Dates Manufacturer Received: 07/16/2020
• Supplement Dates FDA Received: 06/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 47 YR