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

Catalog Number UNKNOWN

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

Patient Problems Vomiting (2144); Regurgitation (2259)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Complaint received from internal personnel via e-mail on 20nov2019--did 20nov2019.Predictors of esophageal self-expandable metal stent migration: an academic center study.As reported to customer relations: "worsening obstructive symptoms vomiting and regurgitation and intervention (removal)." ''of 85 patients included 55 had malignant diseases while 30 patients benign conditions requiring sems placement.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.Overall pain tolerability was reported as 94% with 2 cases of esophageal stent removal due worsening obstructive symptoms vomiting and regurgitation.'.

Manufacturer Narrative

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

Event Description

Complaint received from internal personnel via e-mail on 20nov2019--did 20nov2019.Predictors of esophageal self-expandable metal stent migration: an academic center study.As reported to customer relations: "worsening obstructive symptoms vomiting and regurgitation and intervention (removal)." ''of 85 patients included 55 had malignant diseases while 30 patients benign conditions requiring sems placement.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.Overall pain tolerability was reported as 94% with 2 cases of esophageal stent removal due worsening obstructive symptoms vomiting and regurgitation'.

Event Description

Complaint received from internal personnel via e-mail on 20nov2019--did 20nov2019.Predictors of esophageal self-expandable metal stent migration: an academic center study.As reported to customer relations: "worsening obstructive symptoms vomiting and regurgitation and intervention (removal)." ''of 85 patients included 55 had malignant diseases while 30 patients benign conditions requiring sems placement.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.Overall pain tolerability was reported as 94% with 2 cases of esophageal stent removal due worsening obstructive symptoms vomiting and regurgitation'.

Manufacturer Narrative

Pma/510(k)#: k162717.Device evaluation: the evo (evolution esophageal metal stent ) 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.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 two cases of worsening obstructive symptoms vomiting and regurgitation.Documents review including ifu review: as the evo (evolution esophageal metal stent) device from unknown lot number, a review of the relevant manufacturing records cannot be conducted.Prior to distribution all evo (evolution esophageal metal 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, nausea, food bolus impaction tracheal obstruction and reflux are listed as a potential complication following the placement of this device.Information received is not sufficient enough to confirm that it was the cook stent that contributed to the event.Summary: customer complaint is confirmed based on customer testimony.There were two cases of worsening obstruction symptoms of vomiting and regurgitation requiring medical intervention.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: UNKNOWN
• Type of Device: ESW PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9416369
• MDR Text Key: 169610255
• Report Number: 3001845648-2019-00669
• 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,Followup
• Report Date: 03/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 11/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention