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

Model Number	G48032
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is still pending, a follow-up mdr report will be submitted to include the investigation conclusions.
Event or Problem Description
Mdr- 2054 301-050 ae1 -device issues: tumour overgrowth (stent), specify location; medium, relationship: device; not related, procedure: not related, pre-existing: yes; tumour growth, deficiency: no 180 days post stent placement - tumour overgrowth.New non study cook stent placed endoscopically.
Additional Manufacturer Narrative
Correction initial mdr due to correction to rpn from evo-fc-r-20-25-8-e to evo-20-25-12.5-e.This error was confirmed and change updated on 25-may-2023.No impact to other sections of medwatch report.
Event or Problem Description
Correction initial mdr due to correction to rpn from evo-fc-r-20-25-8-e to evo-20-25-12.5-e.This error was confirmed and change updated on 25-may-2023.No impact to other sections of medwatch report.
Event or Problem Description
The investigation was concluded on the 26-may-2023, this supplement report is being submitted to include the investigation conclusions.
Additional Manufacturer Narrative
Device evaluation: the 1x evo-20-25-12.5-e device of lot number c1287582 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 ingrowth¿.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 is a 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, tumour overgrowth is a known potential adverse events associated with gi endoscopy use.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 stabilised and recovered.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
Supplemental report is being submitted as rpn has been corrected in section d to reflect the field not correctly updated in last mdr.No impact to other scetions of medwatch report.
Additional Manufacturer Narrative
Supplemental report is being submitted as rpn has been corrected in section d to reflect the field not correctly updated in last mdr.No impact to other sections of medwatch report.Pma/510(k) #k162717.Device evaluation the 1x evo-20-25-12.5-e device of lot number c1287582 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 (b)(6) to capture ¿tumour ingrowth¿.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 is a 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, tumour overgrowth is a known potential adverse events associated with gi endoscopy use.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 stabilised and recovered.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED
• Common Device Name: 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: 16852894
• Report Number: 3001845648-2023-00313
• Device Sequence Number: 7566701
• Product Code: ESW
• UDI-Device Identifier: 10827002480329
• UDI-Public: (01)10827002480329(17)181024(10)C1287582
• Combination Product (Y/N): N
• PMA/510(K) Number: K093619
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/03/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/24/2018
• Device Model Number: G48032
• Device Catalogue Number: EVO-20-25-12.5-E
• Device Lot Number: C1287582
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/11/2023; 04/11/2023; 04/11/2023
• Initial Report FDA Received Date: 05/02/2023
• Supplement Report FDA Received Date: 06/22/2023; 08/31/2023; 10/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male