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

Catalog Number EVO-FC-R-20-25-12-E

Device Problem Migration (4003)

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

Event Type  Injury  

Event Description

Mdr- 2054 301-053 ae1 - device issue: stent migration; relationship: device; not related, procedure; not related, pre-existing: no, deficiency: no distal stent migration to stomach - new non study cook evo placed endoscopically patient outcome : status: resolved )patient recovered/stabilized), treatment: endoscopic - new stent placed ( non-study stent), cook evolution, death: no.

Manufacturer Narrative

Investigation is still pending, a follow-up mdr report will be submitted to include the investigation conclusions.

Manufacturer Narrative

Device evaluation: the 01x evo-fc-r-20-25-12-e device of lot number c1316952 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 01 case of stent migration.The following were also raised in response to this pmcf study: (b)(4) - mdr- 2054 301-053 ae3 - device issue, stent migration 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.Historical data review: the review of relevant manufacturing records confirms the failure mode has not previously occurred for this work order.Instructions for use and/label review: as per the ifu (ifu0067), stent misplacement and/or migration is a known potential adverse event associated with gi endoscopy ¿those associated with gi endoscopy include, but are not limited to: perforation, haemorrhage, aspiration, reflux, vomiting, 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.¿ to note, clinical input that was provided stated that ae2 in the study "esophageal stricture" was not related to the cook evolution esophageal stent.Ae3 "stent migration" 250 days post-placement will be captured separately in (b)(4).There is no evidence to suggest that the customer did not follow the instructions for use or product label.Image review: an image was not returned for evaluation.Root cause analysis: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to a procedural adverse event and/or patient pre-existing conditions.As per the instructions for use, stent migration is listed as a known potential complication following the placement of the device.As per clinical input ae2 in the study was not contributed to the cook stent, ae3 will be captured separately.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 pmcf study, the patient did not experience any adverse effects due to this occurrence.After stent migration (140 days post-placement), a new (non-study) stent was placed endoscopically.According to the pmcf study, at the time of exit from the study the patient had recovered/stabilized.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental report is being submitted due to the completion of the investigation on 03-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: 16830914
• MDR Text Key: 314161934
• Report Number: 3001845648-2023-00278
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 10827002551722
• UDI-Public: (01)10827002551722(17)190120(10)C1316952
• Combination Product (y/n): N
• PMA/PMN Number: K093619
• 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: 05/03/2024

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: 01/20/2019
• Device Catalogue Number: EVO-FC-R-20-25-12-E
• Device Lot Number: C1316952
• 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: 04/11/2023
• Initial Date FDA Received: 04/28/2023
• Supplement Dates Manufacturer Received: 04/11/2023
• Supplement Dates FDA Received: 05/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2017
• 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
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 88 KG