MAUDE Adverse Event Report: COOK IRELAND LTD; ESW PROSTHESIS, ESOPHAGEAL

Catalog Number UNKNOWN

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problems Failure of Implant (1924); Obstruction/Occlusion (2422)

Event Type  Injury  

Manufacturer Narrative

510(k) number cannot be provided as the exact rpn is unknown.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Title of literature review: ¿¿predicators of esophageal self-expandable metal stent migration: an academic center study¿¿ jang et all 2016.Complaint received from internal personnel via e-mail on 20nov2019.As reported to customer relations: "migration." additional information added on 04-dec-2019 as per literature review jang et al 2016 overall ''28 cases of stent migration requiring adjustment or replacement '' 3 of which are confirmed cook stents, 1 of these 3 stents required surgical retrieval as noted below.''based on pre-determined definition of serious adverse event , 6 cases (5.7%) of serious adverse outcomes were reported'' including; ''1 cases of stent migration resulting in surgical retrieval''.Therefore 3 cases of stent migration requiring intervention to retrieve or replace / adjust.The choice of stent type (fully covered vs partially covered), brand (wallflex® [boston sci-entific], evolution [cook medical, (b)(6)], hanaro® [m.I.Tech, (b)(6)], and niti-s® [taewoong medical]), and size was determined by the performing endoscopist.

Event Description

Title of literature review: ¿¿predicators of esophageal self-expandable metal stent migration: an academic center study¿¿ jang et all 2016.Complaint received from internal personnel via e-mail on (b)(6) 2019.As reported to customer relations: "migration." additional information added on 04-dec-2019 as per literature review jang et al 2016 overall ''28 cases of stent migration requiring adjustment or replacement '' 3 of which are confirmed cook stents, 1 of these 3 stents required surgical retrieval as noted below: ''based on pre-determined definition of serious adverse event , 6 cases (5.7%) of serious adverse outcomes were reported'' including; ''1 cases of stent migration resulting in surgical retrieval''.Therefore 3 cases of stent migration requiring intervention to retrieve or replace / adjust.The choice of stent type (fully covered vs partially covered), brand (wallflex® [boston sci-entific], evolution [cook medical, bloomington, in, usa], hanaro® [m.I.Tech, pyeongtaek, korea], and niti-s® [taewoong medical]), and size was determined by the performing endoscopist.

Manufacturer Narrative

510(k) number cannot be provided as the exact rpn is unknown.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Manufacturer Narrative

Device evaluation: the evo 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 journal article.From january 2013 to june 2015, there were 154 cases (124 patients) of esophageal sems use in our institution.Of those, 105 cases (85 patients) met the inclusion criteria.Multiple stents from 4 different manufacturers were compared; wall-flex(boston scientific) with 67 cases, hanaro esophageal fc stents (m.I.Tech) with 18 cases, and niti fully covered stents (taewoong medical) in 11 cases and evolution esophageal stent (cook medical) in 9 cases.This file captures 3 cases of stent migration, noted in "table 3.Univariable analysis of factors associated with stent migration" documents review including ifu review: as the evo stent is unknown device from unknown lot number, a review of the relevant manufacturing records cannot be conducted.Prior to distribution all evo (partially and fully covered esophageal stent) 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, ifu0061-6, which informs the user about the potential complications "additional complications include, but are not limited to : perforation, hemorrhage, aspiration, reflux, fever, infection, allergic reaction to medication, hypotension, respiratory depression or arrest, cardiac arrhythmia or arrest.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.On review of the information provided, there is no evidence to suggest that the user did not follow the instructions for use.Root cause review: 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, stent misplacement and/or migration are listed as a potential complication following the placement of this device.Summary: customer complaint is confirmed based on customer testimony.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 completion of investigation.

• Type of Device: ESW PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: aisling hassett ; o halloran road; national technology park; limerick
• MDR Report Key: 9416518
• MDR Text Key: 170214269
• Report Number: 3001845648-2019-00674
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/07/2022

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/20/2019
• Initial Date FDA Received: 12/05/2019
• Supplement Dates Manufacturer Received: 11/20/2019; 11/20/2019
• Supplement Dates FDA Received: 01/02/2020; 02/04/2022
• 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
• Patient Outcome(s): Required Intervention