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 Peritonitis (2252)

Event Date 11/30/2019

Event Type  Injury  

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".The following ae' s are highlighted in the paper: stent migration which led to peritonitis: in the rygb subgroup, there was one patient that required reoperation for a complication directly related to the stent.The patient had a vertical banded gastroplasty converted to rygb, and she then developed a perforation at the gastrojejunostomy which was successfully managed with a stent.The stent was removed after the perforation healed, but her stricture recurred.This was managed again with a stent, which unfortunately migrated to the small bowel anastomosis where it became impacted and eroded through the wall of the bowel.This led to peritonitis requiring exploratory laparotomy with stent retrieval via resection and reconstruction of her gastric bypass.This file will capture 1 case of stent migration which lead to peritonitis requiring laparotomy with stent retrieval.Pr (b)(4) (cook reference #) will capture the other 7 stents which migrated.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, 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.

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 ¿peritonitis¿.Additional complaint files (b)(4) was opened as a result of this paper to capture the other 7 stents which migrated.Reference "(b)(4)." 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".As per medical advisor "clips were used to prevent migration in most cases, which may also be off-label use of our stent in conjunction with clips." 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: 10404602
• MDR Text Key: 210259353
• Report Number: 3001845648-2020-00498
• 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?: Yes
• 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 Outcome(s): Required Intervention
• Patient Age: 47 YR