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

Catalog Number UNKNOWN

Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Failure of Implant (1924)

Event Date 12/15/2016

Event Type  Injury  

Manufacturer Narrative

510(k) number is: k162717.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.Facilities details: department of gastroenterology, endoscopy division, department of gastroenterology, surgery division , cancer institute of the university of são paulo, são paulo, brazil.

Event Description

Adverse events of self-expandable esophageal metallic stents in patients with long-term survival from advanced malignant disease.Medeiros 2017.For lesions located in the proximal esophagus, we used a dedicated model of a partially covered stent with a lowprofile, proximal flare shape (choostent; mi tech, pyeongtaek, korea).For lesions located in the mid-esophagus, we used a standard partially covered stent or, less often, a fully covered stent, with an 18- to 23-mm body diameter and 23- to 28-mm flare diameter (wallflex and ultraflex [boston scientific, watertown, mass], evolution [wilson cook medical, letchworth, uk], hanarostent [mi tech], or endoflex [voerde, germany]).As initially reported to customer relation via emailed literature information from cook europe: migration - ''distal dislodgement but stent remained at the esophagus, endoscopic retraction was achieved using rat- tooth forceps''.5/9 migration - ''stents which migrated into stomach were completely removed with rat-tooth forceps and biliary pusher and received a second stent''.2/9 migration - ''palliative care received (nasoenteral tube)''.2/9 clinical advisor has assigned severity of 4 to all these cases so captured in this pr as per lit review ''curiously all 9 patients who experienced stent migration had a partially covered stent, and none of the patients with fully covered stents presented with this ae''.Based on above cannot confirm that an evo-x-x-x-e (unknown) was used - file being opened conservatively.

Event Description

Adverse events of self-expandable esophageal metallic stents in patients with long-term survival from advanced malignant disease.Medeiros 2017.For lesions located in the proximal esophagus, we used a dedicated model of a partially covered stent with a lowprofile, proximal flare shape (choostent; mi tech, pyeongtaek, korea).For lesions located in the mid-esophagus, we used a standard partially covered stent or, less often, a fully covered stent, with an 18- to 23-mm body diameter and 23- to 28-mm flare diameter (wallflex and ultraflex [boston scientific, watertown, mass], evolution [wilson cook medical, letchworth, uk], hanarostent [mi tech], or endoflex [voerde, germany]).As initially reported to customer relation via emailed literature information from cook europe: migration - ''distal dislodgement but stent remained at the esophagus, endoscopic retraction was achieved using rat- tooth forceps'.' 5/9 migration - ''stents which migrated into stomach were completely removed with rat-tooth forceps and biliary pusher and received a second stent.'' 2/9 migration - ''palliative care received (nasoenteral tube).' 2/9 clinical advisor has assigned severity of 4 to all these cases so captured in this pr as per lit review ''curiously all 9 patients who experienced stent migration had a partially covered stent, and none of the patients with fully covered stents presented with this ae.'' based on above cannot confirm that an evo-x-x-x-e (unknown) was used - file being opened conservatively.

Manufacturer Narrative

The exact rpn for this device is unknown however the most likely 510 k # is the following: k162717.The evo (evolution esophageal 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.Sixty-three patients were included a retrospective analysis of a prospectively collected database including all patients submitted to esophageal stent for palliation of malignant strictures or malignant fistulas between february 2009 and february 2014.Multiple stent brand were used: wallflex and ultraflex [boston scientific, watertown, mass], evolution [wilson cook medical, letchworth, uk], hanarostent [mi tech], and endoflex [voerde, germany]).This file captures migration.As the evo (evolution esophageal stent) device from unknown lot number, a review of the relevant manufacturing records cannot be conducted.Prior to distribution all evo (evolution esophageal stent) controlled-release stent - partially covered) 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 "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.A definitive root cause could not be determined from the available information.Information received is not sufficient enough to confirm that it was the cook stent that contributed to the event.Therefore risk will not be complete due to the limitation of available information.A possible root cause could be attributed to patient condition related, as per instructions for use, stent misplacement and/or migrationare listed as a complication following the placement of this device.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.

Manufacturer Narrative

The exact rpn for this device is unknown however the most likely 510 k#: is the following: k162717.Device evaluation: the evo (evolution esophageal 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.Sixty-three patients were included a retrospective analysis of a prospectively collected database including all patients submitted to esophageal stent for palliation of malignant strictures or malignant fistulas between february 2009 and february 2014.Multiple stent brand were used: wallflex and ultraflex [boston scientific, watertown, mass], evolution [wilson cook medical, letchworth, uk], hanarostent [mi tech], and endoflex [voerde, germany]).This file captures migration (ref.Att."madeiros 2017.Pdf").Documents review including ifu review: as the evo (evolution esophageal stent) device from unknown lot number, a review of the relevant manufacturing records cannot be conducted.Prior to distribution all evo (evolution esophageal stent) controlled-release stent partially covered) 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, ifu0061-5, 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.Information received is not sufficient enough to confirm that it was the cook stent that contributed to the event.Therefore risk will not be complete due to the limitation of available information.A possible root cause could be attributed to patient condition related, as per instructions for use, stent misplacement and/or migrationare listed as a 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

Adverse events of self-expandable esophageal metallic stents in patients with long-term survival from advanced malignant disease.Medeiros 2017.For lesions located in the proximal esophagus, we used a dedicated model of a partially covered stent with a low profile, proximal flare shape (choostent; mi tech, pyeongtaek, korea).For lesions located in the mid-esophagus, we used a standard partially covered stent or, less often, a fully covered stent, with an 18- to 23-mm body diameter and 23- to 28-mm flare diameter (wallflex and ultraflex [boston scientific, watertown, mass], evolution [wilson cook medical, letchworth, uk], hanarostent [mi tech], or endoflex [voerde, germany]).As initially reported to customer relation via emailed literature information from cook europe: migration: ''distal dislodgement but stent remained at the esophagus, endoscopic retraction was achieved using rat, tooth forceps''.On (b)(6).Migration: ''stents which migrated into stomach were completely removed with rat-tooth forceps and biliary pusher and received a second stent''.On (b)(6).Migration: ''palliative care received (nasoenteral tube)''.On (b)(6).Clinical advisor has assigned severity of 4 to all these cases so captured in this pr.As per lit review ''curiously all 9 patients who experienced stent migration had a partially covered stent, and none of the patients with fully covered stents presented with this ae''.Based on above cannot confirm that an evo-x-x-x-e (unknown) was used - file being opened conservatively.

• 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: 9472725
• MDR Text Key: 188591444
• Report Number: 3001845648-2019-00726
• 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: 02/10/2020

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?: Yes
• 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
• Distributor Facility Aware Date: 12/15/2016
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/05/2019
• Initial Date FDA Received: 12/16/2019
• Supplement Dates Manufacturer Received: 12/05/2019; 12/05/2019
• Supplement Dates FDA Received: 02/14/2020; 03/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention