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

Catalog Number EVO-FC-R-20-25-10-E

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Dysphasia (2195); Obstruction/Occlusion (2422)

Event Type  Injury  

Event Description

Device issue: stent migration; endoscopy distal; to stomach, no, reduction in tumor size.Relationship: device: no, procedure: no.Pre-existing: yes; chemo lead to tumor mass reduction.Deficiency: no mdr2054 ae2 - patient (b)(6) resume oral intake within 24hours procedure.No dysphagia score documented during follow up proton pump inhibitor being administered.Tumour reduction therapy administered in follow up¿ chemo day 73 (after placement): stent migration distally to stomach removal of stent as no longer required patient outcome: status: resolved.Treatment: endoscopy; study stent removed.Death: no.

Manufacturer Narrative

Pma/510(k) # k162717 investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Manufacturer Narrative

Pma/510(k) # k162717.Device evaluation: the 01x evo-fc-r-20-25-10-e device of lot number c1524773 involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.This file was created in response to a pmcf study ¿mdr 2054¿ to capture ¿use error (chemo) + stent migration distally to stomach + intervention to remove¿.The following were also raised in response to this pmcf study: 416477: mdr2054 ae1 - patient (b)(6) - stent migration distally to stomach requiring stent repositioning.The device lab evaluation could not be completed as the device, or photographic evidence of the device, was not returned for evaluation.Manufacturing records review: prior to distribution all devices are subjected to a visual inspection and functional inspection to ensure device integrity.A review of the manufacturing records did not reveal any discrepancies that could have contributed to this complaint issue.Instructions for use and/label review: as per the ifu (ifu0067), stent misplacement and/or migration and food bolus impaction are known potential adverse event associated with gi endoscopy ¿those associated with gi endoscopy include, but are not limited to: perforation, haemorrhage, aspiration, reflux, vomitting, fever, infection, allergic reaction to medication, hypotension, respiratory depression or arrest, cardiac arrhythmia or arrest." ¿additional adverse events include, but are not limited to: airway compression, allergic reaction to nickel, aortoesophageal fistula and arterioesophageal fistula, chest or retrosternal pain, death (other than due to normal disease progression) dysphagia, edema, erosion or perforation, esophagitis, fistula involving trachea or bronchi or pleural space, food bolus impaction, foreign body sensation or reaction, gas bloat, inadequate stent expansion, intestinal obstruction secondary to migration, mediastinitis or peritonitis, nausea, pain/discomfort, reocclusion, sensitivity to metal components, sepsis, stent misplacement and/or migration, tracheal obstruction, tumour overgrowth, wire entrapment.¿ there is evidence to suggest that the customer did not follow the instructions for use/product label.It should be noted that the instructions for use (ifu0067) states the following: ¿ after stent placement, alternative methods of treatment such as chemotherapy and radiation should not be administered as this may increase the risk of stent migration due to tumour shrinkage, stent erosion and/or mucosal bleeding¿.As per the patient casebook, the patient underwent post-procedural chemotherapy which therefore deems this complaint use-error.User/use related complaints are considered foreseen misuse.It is unknown how the device will perform outside of instructions for use and/or labelling requirements.The user has not complied with the requirements of the ifu and/label.Trending will monitor if any future investigation is required.As per the patient casebook, ae2 (stent migration) was deemed related to the patients pre-existing conditions due to ¿reduction in tumour size¿.Image review: an image was not returned for evaluation.Root cause analysis: a definitive root cause of use error was identified from the available information.As per the patient casebook, it is known that the patient received alternative treatment post-stent placement.Due to the reduction in tumour size that the chemotherapy would have caused on the malignant intrinsic obstruction, the stent proceeded to migrate distally to the patient¿s stomach 73 days post-placement requiring intervention to remove.Confirmation of complaint: complaint is confirmed based on customer and/or rep testimony.Confirmed quantity of 01x used device.Summary of investigation: according to the initial reporter, the patient did experience an adverse effect due to this occurrence.73 days post-placement the patient experienced distal stent migration to the stomach requiring secondary intervention to remove.Once removed, the patients symptoms resolved and they recovered and stabilised.Complaints of this nature will continue to be monitored for similar events.

Event Description

Supplemental report is being submitted due to the completion of the investigation on 15-may-2024.

• Brand Name: EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED
• 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: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 18380119
• MDR Text Key: 331184594
• Report Number: 3001845648-2023-00940
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/15/2024

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 Expiration Date: 07/31/2020
• Device Catalogue Number: EVO-FC-R-20-25-10-E
• Device Lot Number: C1524773
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/11/2023
• Initial Date FDA Received: 12/21/2023
• Supplement Dates Manufacturer Received: 09/25/2015
• Supplement Dates FDA Received: 05/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 73 KG