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

Catalog Number UNKNOWN

Device Problems Structural Problem (2506); Infusion or Flow Problem (2964)

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

Complaint received from internal personnel via e-mail on 20nov2019--did 20nov2019.Predictors of esophageal self-expandable metal stent migration: an academic center study 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.Of 85 patients included 55 had malignant diseases while 30 patients benign conditions requiring sems placement.2 cases of incomplete expansion of stent flare requiring removal and re-insertion.As reported to customer relations: "stent does not expand and intervention (removal and reinsertion).".

Event Description

Complaint received from internal personnel via e-mail on (b)(6) 2019--did (b)(6) 2019.Predictors of esophageal self-expandable metal stent migration: an academic center study.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.Of 85 patients included 55 had malignant diseases while 30 patients benign conditions requiring sems placement.2 cases of incomplete expansion of stent flare requiring removal and re-insertion as reported to customer relations: "stent does not expand and intervention (removal and reinsertion).".

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

Complaint received from internal personnel via e-mail on 20nov2019--did 20nov2019.Predictors of esophageal self-expandable metal stent migration: an academic center study.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.Of 85 patients included 55 had malignant diseases while 30 patients benign conditions requiring sems placement.2 cases of incomplete expansion of stent flare requiring removal and re-insertion.As reported to customer relations: "stent does not expand and intervention (removal and reinsertion).".

Manufacturer Narrative

As the exact rpn is unknown these are the most likely us clearance numbers: k162717 or k093619.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 was created to address "2 case stent does not expand and intervention (removal and reinsertion) 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 accompanies this device instructs the user to: "there is a lasso at the proximal end of the stent, purpose is to reposition the stent in the event of incorrect placement.".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.However, there may be many possible root causes for the issue encountered if the device in question was an evo device, some may include the following: the suture snagged on the bi-lumen, the stent did not open fully and could not overcome tip, the outer sheath was not fully retracted to allow the stent to be deployed fully or compression from patient anatomy.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.As the device was not returned for evaluation and due to limited information available the cause of this complaint could not be conclusively determined 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 modifications made to the investigation details - removed the line which stated 'therefore risk will not be complete due to the limitation of available information.'.

Manufacturer Narrative

As the exact rpn is unknown these are the most likely us clearance numbers: k162717 or k093619.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 was created to address "2 case stent does not expand and intervention (removal and reinsertion)"(ref.Att."jang16 predictors of esophageal self-expandable metal.Pdf").Lab evaluation: n/a.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 accompanies this device instructs the user to: "there is a lasso at the proximal end of the stent, purpose is to reposition the stent in the event of incorrect placement." on review of the information provided, there is no evidence to suggest that the user did not follow the instructions for use.Image review: n/a.Root cause review: a definitive root cause could not be determined from the available information.However, there may be many possible root causes for the issue encountered if the device in question was an evo device, some may include the following: the suture snagged on the bi-lumen, the stent did not open fully and could not overcome tip, the outer sheath was not fully retracted to allow the stent to be deployed fully or compression from patient anatomy.Information received is not sufficient enough to confirm that it was the cook stent that contributed to the event.As the device was not returned for evaluation and due to limited information available the cause of this complaint could not be conclusively determined 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.

• Brand Name: UNKNOWN
• Type of Device: ESW PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9416292
• MDR Text Key: 169329745
• Report Number: 3001845648-2019-00667
• 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,Followup
• Report Date: 07/28/2021

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• 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; 11/20/2019
• Supplement Dates FDA Received: 01/02/2020; 02/24/2020; 08/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention