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 Perforation (2001); Dysphasia (2195); Obstruction/Occlusion (2422)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Stent 1 - 20 days post placement - stent removed endoscopically - no ae.Stent 2 - second stent placed (c1568003) - requiring supplemetal fixation - ae - 20 days post placement stent migration & distal fistula stricture- endoscopica placement of new stent cook stent.Oral feeding problems treated with nasogastic tube.Stent 3 - third stent placed (c1419319) - no ae.Stent 4 - forth stent placed (c1578089) - no ae.

Manufacturer Narrative

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

Event Description

Supplemental report being submitted due to update of the description of event on 29-aug-2023, as full casebook received on this date and perforation now being captured in current report as well as migration.Updated description of event as follows: ae 1 - 20 days post procedure ¿ ae ¿ distal stent migration confirmed by endoscopy, still partially covering lesion but still in esophagus ¿ endoscopic placement of new stent.Ae 2 - 20 days post procedure distal gastrointestinal perforation - endoscopic placement of new stent (b)(4).Ae 3 ¿ on day of procedure (0 days post placement) ¿ stent migration distally confirmed by endoscopy - partially covering lesion but still in esophagus ¿ at time of migration esophegeal obstruction with retained food ¿ nasogastric tube placed to resolve (b)(4).

Event Description

A supplemental report is being submitted due to an update made to the lot number on 19-mar-2024 and completion of the investigation on 08-apr-2024.

Manufacturer Narrative

Device evaluation: the 01x evo-fc-r-20-25-8-e device of lot number c1484184 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 and perforation.The following were also raised in response to this pmcf study: ¿ pr (b)(4) - device issue: stent migration, endoscopy distal, partially covering lesion but remains in esophagus.Symptoms; other 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.¿ there is no evidence to suggest that the customer did not follow the instructions for use or product label.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.As per the pmcf study, the perforation in ae2 can be linked to stent migration in ae1.Both adverse events occurred exactly 20 days post-placement requiring new stent placement as a result.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.As per the study, both migration and subsequent perforation occurred 20 days post-placement whereby a new (non-study) stent was placed.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: 16852080
• MDR Text Key: 314370566
• Report Number: 3001845648-2023-00297
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 10827002551708
• UDI-Public: (01)10827002551708(17)200514(10)C1484184
• 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: 03/19/2024

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: 05/14/2020
• Device Catalogue Number: EVO-FC-R-20-25-8-E
• Device Lot Number: C1484184
• 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: 04/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2018
• 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: Female