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

Model Number	G48033
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
Mdr- 2054 106-007 ae1.Mdr- 2054 106-007 ae1 - gastrointestinal: other ; stent dislocation distal, relationship: device , related ; stent dislocation needs to reposition, procedure: non related, pre-existing,: no , deficiency: no.2 days post procedure.Stent dislocation distal - stent repositioned endoscopically.Status: resolved, treatment: endoscopic, study stent repositioned, death: no.
Additional Manufacturer Narrative
Pma/510(k) # k162717.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
Supplemental report is being submitted due to the completion of the investigation on 07-mar-2024.
Additional Manufacturer Narrative
Pma/510(k) # k162717.Device evaluation: the 01x evo-20-25-15-e device of lot number c1633088 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 ¿01x case of stent migration¿.The following were also raised in response to this pmcf study/journal article: ¿ pr (b)(4) - mdr- 2054 106-007 ae1 user error chemotherapy after stent placement 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 (ifu0061), stent migration is a known potential adverse event associated with gi endoscopy "those associated with upper gi endoscopy include, but are not limited to: allergic reaction to contrast or medication, aspiration, cardiac arrhythmia or arrest, hemorrhage, hypotension, infection, perforation, reflux, respiratory depression or arrest, vomiting." ¿additional adverse events include, but are not limited to: airway compression, allergic reaction to nickel, retroesophageal fistula and retroesophageal fistula, chest or retrosternal pain, death (other than due to normal disease progression) dysphagia, edema, erosion or perforation of stent into adjacent vascular structures, esophageal ulceration and erosion, 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 ingrowth or overgrowth, wire entrapment.¿ there is evidence to suggest that the customer did not follow the instructions for use/product label.As per the ifu ¿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 noted in the pmcf study, chemotherapy was administered post-placement.Clinical input deemed this unrelated to the stent migration and therefore the use-error will be captured under pr (b)(4).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 and perforation are listed as known potential complications following the placement of the device.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 any adverse effects due to this occurrence.As per the pmcf study, the migrated stent was endoscopically repositioned to re-treat the intrinsic obstruction initially treated.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED
• Common Device Name: 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: 16852579
• Report Number: 3001845648-2023-00306
• Device Sequence Number: 7648226
• Product Code: ESW
• UDI-Device Identifier: 10827002480336
• UDI-Public: (01)10827002480336(17)210719(10)C1633088
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/19/2021
• Device Model Number: G48033
• Device Catalogue Number: EVO-20-25-15-E
• Device Lot Number: C1633088
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/07/2023
• Supplement Date Received by Manufacturer: 04/07/2023
• Initial Report FDA Received Date: 05/02/2023
• Supplement Report FDA Received Date: 03/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 72 KG