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

Model Number G48032

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Obstruction/Occlusion (2422); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) # k162717.Investigation is still pending, a follow-up mdr report will be submitted to include the investigation conclusions.

Event Description

Mdr- (b)(4) - device issues: tumour overgrowth (stent), specify location; cardia, relationship: device; not related, procedure; not related, pre-existing; yes, tumour, deficiency; no.Tumor overgrowth (stent) - cardia - new stent placed (non-study stent).Patient outcome: status: event ongoing, treatment endoscopic; new stent placed (non-study stent); cook evolution, death: yes.

Event Description

This supplemental report is being submitted due to completion of the investigation on the 25-may-2023.

Manufacturer Narrative

Pma/510(k) # k162717.Device evaluation: the 1x evo-20-25-12.5-e device of lot number c1200885 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 the pmcf study mdr-2054 to capture ¿tumour overgrowth¿ lab evaluation: the device lab evaluation could not be completed as the device, or photographic evidence of the device, was not returned for evaluation.Document 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.Ifu & label review: as per the ifu (ifu0061), tumour overgrowth and death (other than due to normal disease progression) are known potential adverse event associated with upper gi endoscopy ¿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 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 review: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to known procedural adverse events associated with the use of gi endoscopy on the patient.As per the ifu, both death (other than due to normal disease progression) and stent overgrowth are known potential adverse events associated with gi endoscopy.The patient death reported in the study was deemed to be unrelated to the cook stent placed in the patient and was attributed to the primary disease (malignancy) progression 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.A new (non-study) stent was placed to treat the tumour overgrowth.The patient died 130 days post-placement of the study stent with the cause of death being primary disease progression.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY 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: 16830475
• MDR Text Key: 314159372
• Report Number: 3001845648-2023-00275
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 10827002480329
• UDI-Public: (01)10827002480329(17)180210(10)C1200885
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/25/2023

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/10/2018
• Device Model Number: G48032
• Device Catalogue Number: EVO-20-25-12.5-E
• Device Lot Number: C1200885
• 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: 04/11/2023
• Initial Date FDA Received: 04/28/2023
• Supplement Dates Manufacturer Received: 04/11/2023
• Supplement Dates FDA Received: 06/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2016
• 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: Female