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

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fever (1858)

Event Date 10/13/2016

Event Type  Injury  

Manufacturer Narrative

The 510(k) number: k162717.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.[(b)(4)].

Event Description

Title of literature review: ''factors that affect stent -related complications in patients with malignant obstruction of the esophagus or gastric cardia'' iwasaki et al 2017 major complications occurred in 14 patients (26.4%), including six (11.3%) with fever 6 cases fever requiring assumed intervention as the literature review considered this a 'major complication', however as table 1 confirms only 1 cook evolution stent was used out of 53 which were used overall, therefore only 1 case of fever requiring assumed intervention could have potentially been attributed to a cook evolution stent.This file has been opened to capture 1 case of fever requiring assumed intervention that could have potentially been attributed to a cook evolution stent.The use of a cook stent in this instance cannot be confirmed so this is a conservative assessment.Clinical advisor: fever normally is minor aes, however it was considered as major complication three types of stent were used in this literature review: partially or uncovered ultraflex stents (boston scientific), partially covered or uncovered niti-s stents (taewoong medical) and partially covered evolution stents (cook medical).We cannot confirm that the cook evolution stent was related to this specific adverse event so this is a conservative assessment.

Manufacturer Narrative

Pma/510(k)#: k162717.The evo -pc- e device of unknown lot number was not returned to cook ireland for evaluation.With the information provided, document-based investigation was conducted.This file was created from the attached journal article.Literature review outlines major complications which occurred in 14 patients (26.4%), including six (11.3%) with fever 6 cases fever requiring assumed intervention as the literature review considered this a 'major complication', however as table 1 confirms only 1 cook evolution stent was used out of 53 which were used overall, therefore only 1 case of fever requiring assumed intervention could have potentially been attributed to a cook evolution stent.Three types of stent were used in this literature review: partially or uncovered ultraflex stents (boston scientific), partially covered or uncovered niti-s stents (taewoong medical) and partially covered evolution stents (cook medical).We cannot confirm that the cook evolution stent was related to this specific adverse event so this is a conservative assessment.This file captures 1 case of 1 case of fever requiring assumed intervention.This could have potentially been related to a cook evolution stent however we are unable to confirm, this is a conservative assessment.As the evo -pc- e device from unknown lot number, a review of the relevant manufacturing records cannot be conducted.Prior to distribution all evo -pc- e devices are subject to visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.As per the instructions for use, which informs the user about the potential complications "potential complications associated with ercp include, but are not limited to: pancreatitis, cholangitis, cholecystitis, cholestasis, aspiration, perforation, haemorrhage, infection, sepsis, allergic reaction to contrast or medication , hypotension, respiratory depression or arrest, cardiac arrhythmia or arrest.Additional complications that can occur in conjunction with biliary stent placement include, but are not limited to: trauma to the biliary tract or duodenum; perforation; obstruction of the pancreatic duct; stent migration; stent occlusion; ingrowth due to tumor or excessive hyperplastic tissue; tumor overgrowth; stent misplacement, pain, fever, nausea, vomiting, inflammation, recurrent obstructive jaundice, bile duct ulceration, death (other than due to normal disease progression)¿ on review of the information provided, there is no evidence to suggest that the user did not follow the instructions for use.A definitive root cause could not be determined from the available information.A possible root cause could be attributed to patient condition related, as per instructions for use, fever is listed as a potential complication.Information received is not sufficient enough to confirm that it was the cook stent that contributed to the event.Customer complaint is confirmed based on customer testimony.The patient suffered a fever.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Title of literature review: ''factors that affect stent -related complications in patients with malignant obstruction of the esophagus or gastric cardia'' iwasaki et al 2017 major complications occurred in 14 patients (26.4%), including six (11.3%) with fever 6 cases fever requiring assumed intervention as the literature review considered this a 'major complication', however as table 1 confirms only 1 cook evolution stent was used out of 53 which were used overall, therefore only 1 case of fever requiring assumed intervention could have potentially been attributed to a cook evolution stent.This file has been opened to capture 1 case of fever requiring assumed intervention that could have potentially been attributed to a cook evolution stent.The use of a cook stent in this instance cannot be confirmed so this is a conservative assessment.Clinical advisor: fever normally is minor aes, however it was considered as major complication.Three types of stent were used in this literature review: partially or uncovered ultraflex stents (boston scientific), partially covered or uncovered niti-s stents (taewoong medical) and partially covered evolution stents (cook medical).We cannot confirm that the cook evolution stent was related to this specific adverse event so this is a conservative assessment.

• Brand Name: EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED
• Type of Device: ESW PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9489561
• MDR Text Key: 187376122
• Report Number: 3001845648-2019-00744
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• 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: 03/18/2020

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/13/2016
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/05/2019
• Initial Date FDA Received: 12/18/2019
• Supplement Dates Manufacturer Received: 12/05/2019
• Supplement Dates FDA Received: 03/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention