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

Patient Problems Hemorrhage/Bleeding (1888); Gastrointestinal Hemorrhage (4476)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

(b)(4).Tumour reduction therapy within 30 days prior procedure - chemo.Ae 2 - 5 days post placement - massive gi bleed requiring blood transfusion - related to stent - bleeding post stent insertion.Patient outcome: bleeding post stent insertion.

Event Description

Supplemental report is being submitted due to the completion of the investigation on the 06-jun-2023.

Manufacturer Narrative

Device evaluation: the 1x evo-fc-20-25-12-e device of lot number c1300361 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 a ¿gastrointestinal bleed.¿ 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 (ifu0061), hemorrhage is a known potential adverse event associated with upper gi endoscopy ¿those associated with upper gi endoscopy include, but are not limited to: allergic reaction to contrast or medication, aspiration, cardiac arrhythmia or arrest, fever, hemorrhage, hypotension, infection, perforation, reflux, respiratory depression or arrest, vomiting.¿ death (other than due to normal disease progression) is also a known potential adverse events as per the ifu: ¿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 analysis: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to known procedural adverse events.As per the ifu, hemorrhage and death (other than due to normal disease progression) are known potential adverse events.Input from the medical advisor determined that the gi bleed associated with his complaint was not caused by the study device.The tumour reduction chemotherapy that was given to the patient within 30 days prior to the procedure might have contributed to the bleeding.As per the casebook, the pre-existing conditions prior to stent placement and co-morbidity diagnosed post placement were deemed related to the cause of death.Confirmation of complaint: complaint is confirmed based on customer and/or rep testimony.Summary of investigation: according to the pmcf study, the patient suffered a 'massive gi bleed' which resulted in the patients death.Confirmed quantity of 1 device.Confirmed used.According to the pmcf study, the patient did experience an adverse event as a result of this occurrence.The patient suffered a gi haemorrhage 05 days post stent placement requiring a blood transfusion as treatment.07 days post stent placement the patient died.The cause of death was attributed to ¿massive gi bleed¿ with ¿pre-existing conditions prior to procedure¿ and ¿co-morbidity diagnosed after stent placement¿ given as being related to the cause of death.Investigation findings concluded a definitive root cause could not be determined.A possible root cause was attributed to a procedural adverse effect as haemorrhage and death are both known a known potential adverse events associated with upper gi endoscopy.Input received determined that the study stent was not a contributing factor to the bleed and death, while the tumour reduction chemotherapy the patient received might have contributed to these events.Complaint is confirmed based on customer and/or rep testimony.Complaints of this nature will continue to be monitored for potential emerging trends.

Manufacturer Narrative

Device evaluation: the 1x evo-fc-r-20-25-12-e device of lot number c1300361 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 a ¿gastrointestinal bleed¿.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), hemorrhage is a known potential adverse event associated with upper 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." death (other than due to normal disease progression) is also a known potential adverse events as per the ifu: ¿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.¿ 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 known procedural adverse events.As per the ifu, hemorrhage and death (other than due to normal disease progression) are known potential adverse events.Input from the medical advisor determined that the gi bleed associated with his complaint was not caused by the study device.The tumour reduction chemotherapy that was given to the patient within 30 days prior to the procedure might have contributed to the bleeding.As per the casebook, the pre-existing conditions prior to stent placement and co-morbidity diagnosed post placement were deemed related to the cause of death.Confirmation of complaint: complaint is confirmed based on customer and/or rep testimony.Summary of investigation: according to the pmcf study, the patient suffered a 'massive gi bleed' which resulted in the patients death.Confirmed quantity of 1 device.Confirmed used.According to the pmcf study, the patient did experience an adverse event as a result of this occurrence.The patient suffered a gi haemorrhage 05 days post stent placement requiring a blood transfusion as treatment.07 days post stent placement the patient died.The cause of death was attributed to ¿massive gi bleed¿ with ¿pre-existing conditions prior to procedure¿ and ¿co-morbidity diagnosed after stent placement¿ given as being related to the cause of death.Investigation findings concluded a definitive root cause could not be determined.A possible root cause was attributed to a procedural adverse effect as haemorrhage and death are both known a known potential adverse events associated with upper gi endoscopy.Input received determined that the study stent was not a contributing factor to the bleed and death, while the tumour reduction chemotherapy the patient received might have contributed to these events.Complaint is confirmed based on customer and/or rep testimony.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental correction report is being submitted due to the update of the rpn from evo-fc-20-25-12-e to evo-fc-r-20-25-12-e due to the receipt of complaint form on 18-sep-2023.

• 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: 16851989
• MDR Text Key: 314387094
• Report Number: 3001845648-2023-00287
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 10827002551722
• UDI-Public: (01)10827002551722(17)181130(10)C1300361
• 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: 09/18/2023

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: EVO-FC-R-20-25-12-E
• Device Lot Number: C1300361
• 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: 04/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2016
• 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 Age: 51 YR
• Patient Sex: Male