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

Catalog Number EVO-FC-R-20-25-8-E

Device Problem Migration (4003)

Patient Problems Abscess (1690); Perforation of Esophagus (2399); Obstruction/Occlusion (2422); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Mdr- (b)(4) - device issues: stent migration, relationship: device; not related.Procedure; not related, pre-existing: yes; tumour on cardia.Deficiency: no.The prosthesis migrates to the stomach and is removed by surgery.A new, longer, fully covered stent was placed; however, the distal end was supported by the surgical suture, so it was decided to remove it and not insert any.Patient outcome: event: resolved ( patient recovered / stabilized), treatment: surgical; removal of stent from stomach, death: no.

Event Description

This supplemental report is being submitted as a correction report to the description of events."this complaint will capture the following: the prosthesis migrates to the stomach and is removed by surgery.A new, longer, fully covered stent was placed; however, the distal end was supported by the surgical suture, so it was decided to remove it and not insert any.Perforation of the posterior aspect of the gastric fundus with a migrated stent.Two abdominal abscesses secondary to perforation by migrated stent.The perforation and subsequent abscesses were deemed a cascading effect of the initial stent migration by the medical advisor¿s clinical input." event: resolved ( patient recovered/stabilized), treatment: surgical; removal of stent from stomach, death: no.

Manufacturer Narrative

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

Event Description

Supplemental report is being submitted due to the completion of the investigation on 08-apr-2024.

Manufacturer Narrative

Pma/510(k) # k162717 device evaluation: the 01x evo-fc-r-20-25-8-e device of lot number c1711649 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, perforation, and abscesses.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 and perforation are 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.¿ clinical input confirmed that the perforation noted in the study was a cascading effect of the stent migration.The subsequent abscesses were due to the stent perforation.There is no evidence to suggest that the customer did not follow the instructions for use or product label.The alternative treatment noted in the study (chemotherapy) was administered post-stent removal therefore there is no evidence to suggest any use-error.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, perforation, and infection are listed as known potential complications following the placement of the device.As per clinical input, both the perforation and abscess' (infection) were attributed to the stent migration in the patient.As per the pmcf study, it was noted that the ¿tumour in the cardia¿ was a contributing factor to the stent migration and subsequent perforation.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 migration and the subsequent perforation (0 days post-placement), the stent was surgically removed from the patient¿s stomach, and a jejunostomy was performed for feeding.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.

• 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: 16852487
• MDR Text Key: 314394016
• Report Number: 3001845648-2023-00303
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 10827002551708
• UDI-Public: (01)10827002551708(17)220225(10)C1711649
• 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,Followup
• Report Date: 04/08/2024

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: 02/25/2022
• Device Catalogue Number: EVO-FC-R-20-25-8-E
• Device Lot Number: C1711649
• 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: 04/07/2023
• Initial Date FDA Received: 05/02/2023
• Supplement Dates Manufacturer Received: 04/07/2023; 04/07/2023
• Supplement Dates FDA Received: 09/27/2023; 05/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2020
• 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 Sex: Male