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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT -FULLY COVERED; ESW PROSTHESIS, ESOPHAGEAL
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COOK IRELAND LTD EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT -FULLY COVERED; ESW PROSTHESIS, ESOPHAGEAL Back to Search Results
Catalog Number UNKNOWN
Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Perforation (2001); Ulcer (2274); Obstruction/Occlusion (2422)
Event Type  Injury  
Event Description
Mdr2054 201-027 ae2.Stent migration.80 days post placement stent migration distally - stent removed endoscopically - ryles inserted.Patient outcome: resolved; treatment endoscopic - study stent removed, medical ryles inserted; death yes.
 
Manufacturer Narrative
Investigation is still pending, a follow-up mdr report will be submitted to include the investigation conclusions.
 
Event Description
This correction follow-up report is being submitted due to below updates made to the complaint record on 05-may-2023: 1.User error identified as physician/assistant performed alternative treatment method post placement of stent - chemotherapy treatment after stent placement.2.Section 10.Medical device problem code (annex a) changed from a24 - adverse event without identified device or use problem to a2303 - improper or incorrect procedure or method.3.Section 10.Component code (annex g) changed from g04122 - stent to g07001 - part/component/sub-assembly term not applicable.
 
Manufacturer Narrative
Investigation is still pending, a follow-up mdr report will be submitted to include the investigation conclusions.
 
Event Description
This is a supplemental report due to the completion of the investigation on the 03-aug-2023.
 
Manufacturer Narrative
User/use related complaints are considered foreseen misuse.It is unknown how the device will perform outside of instructions for use and/or labelling requirements.The user has not complied with the requirements of the ifu and/label.Trending will monitor if any future investigation is required.Device evaluation.The device evaluation for evolution® esophageal controlled-release stent -fully covered could not be completed as the device or photographic evidence of the device was not returned for evaluation.Manufacturing records.Prior to distribution all devices are subjected to a visual inspection and functional inspection to ensure device integrity.Manufacturing records review could not be completed as the lot number is unknown.Instructions for use and/label.The instructions for use, ifu0061 which accompanies this device, states ¿after stent placement, alternative methods of treatment such as chemotherapy and tumour shrinkage should not be administered this may increase risk of stent migration due to tumour shrinkage, stent erosion, and/or mucosal bleeding.¿¿ there is evidence to suggest that the customer did not follow the instructions for use.Image review.An image was not returned for evaluation.Root cause analysis.Definitive root cause was established.The user has not complied with the requirements of the ifu and/label.It is known from the available information that the patient received chemotherapy after stent placement.As per instructions for use after stent placement, alternative methods of treatment such as chemotherapy and tumour shrinkage should not be administered this may increase risk of stent migration due to tumour shrinkage, stent erosion, and/or mucosal bleeding.It is likely that the follow up chemotherapy resulted in the stent migration.The patient death was unrelated to the study device.Confirmation of complaint.Complaint is confirmed based on customer and/or rep testimony.Corrective action/ correction.Complaints of this nature will continue to be monitored for potential emerging trends.Summary of investigation.According to the pmcf study the patient received chemotherapy post stent placement and 80 days post stent placement the stent migrated distally.Confirmed quantity of 1 device, confirmed used.The patient did not experience any adverse effects due to this occurrence.The migrated stent was removed endoscopically.Investigation findings conclude a definitive root cause was established.The user has not complied with the requirements of the ifu and/label.
 
Event Description
Supplemental correction report being submitted due to us decision tree is only for malfunction but should be serious injury based on the migration and the f code applied.Section b1 " adverse event and/or product problem" left blank in complete #2 mdr report.
 
Manufacturer Narrative
Supplemental correction report being submitted due to us decision tree is only for malfunction but should be serious injury based on the migration and the f code applied.Section b1 " adverse event and/or product problem" left blank in complete #2 mdr report.User/use related complaints are considered foreseen misuse.It is unknown how the device will perform outside of instructions for use and/or labelling requirements.The user has not complied with the requirements of the ifu and/label.Trending will monitor if any future investigation is required.Device evaluation the device evaluation for evolution® esophageal controlled-release stent -fully covered could not be completed as the device or photographic evidence of the device was not returned for evaluation.Manufacturing records prior to distribution all devices are subjected to a visual inspection and functional inspection to ensure device integrity.Manufacturing records review could not be completed as the lot number is unknown.Instructions for use and/label the instructions for use, ifu0061 which accompanies this device, states ¿after stent placement, alternative methods of treatment such as chemotherapy and tumour shrinkage should not be administered this may increase risk of stent migration due to tumour shrinkage, stent erosion, and/or mucosal bleeding.¿¿ there is evidence to suggest that the customer did not follow the instructions for use.Image review an image was not returned for evaluation.Root cause analysis definitive root cause was established.The user has not complied with the requirements of the ifu and/label.It is known from the available information that the patient received chemotherapy after stent placement.As per instructions for use after stent placement, alternative methods of treatment such as chemotherapy and tumour shrinkage should not be administered this may increase risk of stent migration due to tumour shrinkage, stent erosion, and/or mucosal bleeding.It is likely that the follow up chemotherapy resulted in the stent migration.The patient death was unrelated to the study device.Confirmation of complaint complaint is confirmed based on customer and/or rep testimony.Corrective action/ correction complaints of this nature will continue to be monitored for potential emerging trends.Summary of investigation according to the pmcf study the patient received chemotherapy post stent placement and 80 days post stent placement the stent migrated distally.Confirmed quantity of 1 device, confirmed used.The patient did not experience any adverse effects due to this occurrence.The migrated stent was removed endoscopically.Investigation findings conclude a definitive root cause was established.The user has not complied with the requirements of the ifu and/label.
 
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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 Key16852551
MDR Text Key314373201
Report Number3001845648-2023-00304
Device Sequence Number1
Product Code ESW
Combination Product (y/n)N
PMA/PMN Number
K093619
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative,Distributor
Reporter Occupation Other
Type of Report Initial,Followup,Followup,Followup
Report Date 08/03/2023
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
Device Operator Health Professional
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
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 Received05/02/2023
Supplement Dates Manufacturer Received04/11/2023
04/11/2023
04/11/2023
Supplement Dates FDA Received06/02/2023
08/28/2023
03/28/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age43 YR
Patient SexMale
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