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

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

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

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Procedure: was the stent placed at the intended location at completion of the procedure? yes.Were any additional procedure (s) performed during the study procedure? no.Were any adverse events documented during the stent procedure? no.Were any device deficiencies documented during the placement procedure? no.Was tumor-reduction therapy documented during follow up? yes-chemotherapy.User error: patient received chemotherapy after stent placement and stent removal ((b)(4)).Adverse event: dislocation of the stent + sporadic abdominal pain left side ((b)(4)) were there any medical problems or complications documented after the study procedure and through follow-up medical record review? yes.Adverse event onset (days post stent placement): 8.Event treatment: study stent removed.Was the event considered to be related to the study device? related.If related, please provide a detail description of how study device caused or contributed to this event: dislocation of the stent.Was the event considered to be related to the study procedure? related.If related, please provide a detail description of how study procedure caused or contributed to this event: after placement dislocation of the stent.Did a pre-existing condition, or other condition or circumstance cause or contribute to this event? yes-thoracic stomach.Did the event occur due to a device deficiency? no.At the conclusion of follow-up what was the status of the study stent: stent removed endoscopically primary reason for study exit: placement of non-study stent event status at time of study exit: resolved (patient recovered/stabilized).

Manufacturer Narrative

Device evaluation: the evo-fc-20-25-10-e device of an unknown lot number 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 ¿(b)(4)¿ to capture ¿01x case of use error of chemotherapy being administered post stent placement resulting in dislocation of the stent and subsequent abdominal pain." note an additional related complaint pr#380425 (patient 104-008 - user error: patient received chemotherapy after stent placement and stent removal) / mdr ref# 3001845648-2022-00838 will be cancelled as this complaint captures the chemotherapy received post-placement.Clinical input confirmed that the chemotherapy administered could have contributed to the dislocation and subsequent abdominal pain the patient had.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.Manufacturing records review could not be completed as the lot number is unknown.Instructions for use and/label review: as per the ifu (ifu0061), stent migration and pain/discomfort are both known potential adverse event associated with upper 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.It should be noted that the instructions for use (ifu0061) 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.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.It is known from the available information that the patient received chemotherapy after stent placement.As per instructions for use 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 likely that the follow up chemotherapy contributed to the stent migration.As per clinical input, the chemotherapy received during follow-up would have likely contributed to the stent dislocation and sporadic abdominal pain.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.The patient had stent dislocation and required the stent to be removed endoscopically and at the time of the study exit 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 (b)(6) 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: 15914944
• MDR Text Key: 304793520
• Report Number: 3001845648-2022-00833
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 01/30/2024
• 2 Devices were Involved in the Event: 1 2

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: 08/01/2021
• Device Catalogue Number: EVO-FC-20-25-10-E
• Device Lot Number: UNKNOWN
• 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: 11/08/2022
• Initial Date FDA Received: 12/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2019
• 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: 82 YR
• Patient Sex: Male
• Patient Weight: 92 KG