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); Dent in Material (2526); Migration (4003)

Patient Problems Fistula (1862); No Clinical Signs, Symptoms or Conditions (4582)

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.Adverse event: stent migration.Adverse event onset (days post stent placement):120.Confirmed by endoscopy.Direction of migration: distal.Provide degree of migration: to stomach.Event treatment: new stent placed (non-study stent) ultraflex 10 cms x 23 mms.Was the event considered to be related to the study device? not related.Was the event considered to be related to the study procedure? not related.Did a pre-existing condition, or other condition or circumstance cause or contribute to this event? no.At the conclusion of follow-up what was the status of the study stent: the stent remained in place (or inside the patient) at 6 months post placement or at the time of death.Event status at time of study exit: resolved (patient recovered/stabilized).

Event Description

Supplemental follow-up report is being submitted due to the completion of the investigation and an update to the investigation conclusions on the 07-apr-2023.

Manufacturer Narrative

Device evaluation: the device evaluation for evo-fc-r-20-25-12-e of lot c1386147 could not be completed as the device or photographic evidence of the device was not returned for evaluation lab evaluation: n/a documents review including ifu review: prior to distribution all devices are subjected to a visual inspection and functional inspection to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.A review of the manufacturing records of lot c1386147 did not reveal any discrepancies that could have contributed to this complaint issue the review of relevant manufacturing records of lot number c1386147 confirms the failure mode has not previously occurred for this work order.The instructions for use, ifu0067 which accompanies this device, it informs the user about the potential complications "additional complications include, but are not limited to: stent misplacement and/or migration".There is no evidence to suggest that the customer did not follow the instructions for use.Image review: n/a root cause analysis: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to patient condition related, as per instructions for use, stent migration is listed as a potential complication following the placement of this device.Summary: complaint is confirmed based on customer and/or rep testimony.According to the initial reporter, the patient did experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental follow-up report is being submitted due to update to the investigation (user error) and an update to the investigation conclusions on the 25-jan-2024.

Manufacturer Narrative

Device evaluation: the 01x evo-fc-r-20-25-12-e device of lot number c1386147 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 ¿mdr2054¿ to capture 01x case of use error for exceeding recommended indwell time resulting in 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.Instructions for use and/label review: as per the ifu (ifu0067), stent 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, 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.It should be noted that the instructions for use (ifu0067) states the following: ¿the safety and effectiveness of leaving this stent in place, or removing the evolution esophageal stent ¿ fully covered from a benign lesion beyond 8 weeks has not been established.¿.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.The stent has been left in place for 120 days which is beyond the recommended 56 days (8 weeks).The instructions for use, ifu0067 which accompanies this device, instructs the user that: ¿the safety and effectiveness of leaving this stent in place, or removing the evolution esophageal stent ¿ fully covered from a benign lesion beyond 8 weeks has not been established.It is possible that the user error of the stent being left in place beyond the recommended 8 weeks contributed to the stent migration.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 not experience any adverse effects due to this occurrence.As per the patient casebook, the patient required a new, non-study stent to be placed as treatment for the migration of the evo-fc-r-20-25-12-e stent.Complaints of this nature will continue to be monitored for potential emerging trends.

• 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: 15914918
• MDR Text Key: 304792784
• Report Number: 3001845648-2022-00832
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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,Followup
• Report Date: 01/25/2024

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: 08/04/2019
• Device Catalogue Number: EVO-FC-R-20-25-12-E
• Device Lot Number: C1386147
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/07/2022
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/08/2022
• Initial Date FDA Received: 12/05/2022
• Supplement Dates Manufacturer Received: 11/08/2022; 11/08/2022
• Supplement Dates FDA Received: 05/04/2023; 02/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2017
• 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: 58 YR
• Patient Sex: Male
• Patient Weight: 61 KG