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 Problems Improper or Incorrect Procedure or Method (2017); Migration (4003)

Patient Problems Dysphagia/ Odynophagia (1815); Obstruction/Occlusion (2422)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Gastrointestinal- dysphagia; device related, procedure-not related, pre-existing- yes.40 days post placement gastrointestinal dysphagia - intervention egis placed, cook removed due to migration.Patient outcome : resolved, treatment-endoscopic new stent placed (non study stent) egis placed, cook removed.

Manufacturer Narrative

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

Event Description

This correction follow-up report is being submitted due to additional information being received on 30-aug-2023 resulting in product details section rpn being changed to evo-fc-r-20-25-12-e.

Manufacturer Narrative

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

Event Description

This correction follow-up report is being submitted due to below updates made to the complaint record on (b)(6)2023: 1.User error identified as chemotherapy was performed post stent placement - 40 days post placement gastrointestinal dysphagia - intervention egis placed, cook stent removed due to migration 2.Section 10.Medical device problem code (annex a) changed.From a010402 - migration.To a2303 - improper or incorrect procedure or method.3.Section 10.Component code (annex g) changed.From g04122 - stent.To g07001 - part/component/sub-assembly term not applicable.

Event Description

Supplemental report is being submitted due to the completion of the investigation on 17-oct-23.Rpn has also been corrected in section d to reflect the field not correctly updated in last mdr.

Manufacturer Narrative

Device evaluation: 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.The device evaluation for evo-fc-r-20-25-12-e of lot c1332875 could not be completed as the device or photographic evidence of the device was not returned for evaluation.Manufacturing records: prior to distribution all devices are subjected to a visual inspection and functional inspection to ensure device integrity.A review of the manufacturing records of lot c1332875 did not reveal any discrepancies that could have contributed to this complaint issue.Instructions for use and/label : the instructions for use, ifu0067 which accompanies this device, states ¿after stent placement, alternative methods of treatment such as chemotherapy and tumour shrinkage should not be administered this may increase risk of stent migration due to tumour shrinkage, stent erosion, and/or mucosal bleeding.¿¿ 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 of stent into adjacent vascular structures , esophageal ulceration and erosion, esophagitis, fistula involving trachea, 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, reclusion, sensitivity to metal components, sepsis, stent misplacement and/or migration, tracheal obstruction , tumour over growth and wire entrapment.There is evidence to suggest that the customer did not follow the instructions for use.Image review: an image was not returned for evaluation.Root cause analysis: definitive root cause was established.The user has not complied with the requirements of the ifu and/label.It is known from the available information that the patient received chemotherapy after stent placement.The instructions for use, ifu0067 which accompanies this device, states ¿after stent placement, alternative methods of treatment such as chemotherapy and tumour shrinkage should not be administered this may increase risk of stent migration due to tumour shrinkage, stent erosion, and/or mucosal bleeding.¿¿ it is possible the patient receiving chemotherapy contributed to the stent migration and it is known from the available information that the stent migration caused or contributed to the gastrointestinal dysphagia that was reported 40 days post stent placement.Confirmation of complaint: complaint is confirmed based on customer and/or rep testimony.Corrective action/ correction: complaints of this nature will continue to be monitored for potential emerging trends.Summary of investigation: according to the pmcf study gastrointestinal dysphagia was reported 40 days post stent placement.Confirmed quantity of 1 device, confirmed used.According to the initial report, the patient required a new stent to be placed as treatment for the stent migration and dysphagia.The cook stent was removed due to the migration.Investigation findings conclude a definitive root cause was established.The user had not complied with the requirements of the ifu with respect to the intended use of the device.

• 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: 16852766
• MDR Text Key: 314373122
• Report Number: 3001845648-2023-00310
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 10827002551722
• UDI-Public: (01)10827002551722(17)190306(10)C1332875
• Combination Product (y/n): N
• PMA/PMN Number: K093619
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/06/2019
• Device Catalogue Number: EVO-FC-R-20-25-12-E
• Device Lot Number: C1332875
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 04/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2017
• 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: 72 YR
• Patient Sex: Male