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

Catalog Number	EVO-20-25-10-E
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Structural Problem (2506)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Type of Reportable Event	Serious Injury
Event or Problem Description
Device issue: inadequate stent expansion.Relationship questions study device: blank, procedure: not related.Pre-existing: blank.Device deficiency: blank.As per attached patient casebook, " 1.Date of procedure: (b)(6) 2018 2.Reason for stent placement: malignant obstruction (extrinsic) 3.Morphology of study lesion: length of study lesion: 8 (cm); diameter of esophagus at the location of the study lesion 9 (mm)." "post-procedural information: 4.Was tumor-reduction therapy documented during follow up? no 5.Were there any medical problems or complications documented after the study procedure and through follow-up medical record review? no 6.Were any device deficiencies documented after the study procedure and through follow-up medical record review; including device deficiencies that may have occurred during stent repositioning or removal? no" "2.Adverse event onset (days post stent placement): 26 7.Were any adverse events documented during the stent procedure? yes 8.Were any device deficiencies documented during the placement procedure? no 3.Event category (select only one event per form): device issues -- inadequate stent expansion 4.Event treatment: endoscopic - study stent repositioned 5.Was the event considered to be related to the study procedure? not related" treatment: endoscopic; study stent repositioned.
Additional Manufacturer Narrative
Pma/510(k) #k162717 investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Additional Manufacturer Narrative
Pma/510(k) # k162717.Device evaluation the device evaluation for the evo-20-25-10-e device lot c1465258 could not be completed as the device or photographic evidence of the device was not returned for evaluation.This file was created in response to a pmcf study ¿mdr2054_mdr2055 102 102_013_ae1 evo-20-25-10-e¿.This file is related to (b)(4) / 3001845648-2024-00076 which captures the user error of the stent being repositioned 26 days post stent placement.Manufacturing records: prior to distribution all devices are subjected to a visual inspection and functional inspection to ensure device integrity.A review of the manufacturing records of lot c1465258 did not reveal any discrepancies that could have contributed to this complaint issue.Review historical data: the review of relevant manufacturing records of lot number c1465258 confirms the failure mode has not previously occurred for this work order.Instructions for use and/label.The instructions for use, ifu0061 which accompanies this device, instructs the user that ¿¿ 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 of stent into adjacent vascular structures , esophageal ulceration and erosion, esophagitis, fistula involving trachea, 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, reclusion, sensitivity to metal components, sepsis, stent misplacement and/or migration, tracheal obstruction , tumour over growth and wire entrapment.There is no 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.A definitive root cause could not be determined.It is possible that extrinsic hard tumour expression could have led to inadequate stent expansion.It is known from the available information that the stent was used to treat a malignant extrinsic obstruction.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 inadequate stent expansion was reported 26 days post stent placement.Confirmed quantity of 1 device, confirmed used.According to the pmcf study the stent was repositioned 26 days post placement.The stent remained in place at 6 months post placement or at the time of death.Investigation findings conclude that the extrinsic hard tumour expression could have led to the inadequate stent expansion reported.
Event or Problem Description
Supplemental report is being submitted due to the completion of the investigation on 09-feb-2024.
Additional Manufacturer Narrative
Pma/510(k) # k162717 device evaluation the device evaluation for the evo-20-25-10-e device lot c1465258 could not be completed as the device or photographic evidence of the device was not returned for evaluation.This file was created in response to a pmcf study ¿mdr2054_mdr2055 102 102_013_ae1 evo-20-25-10-e¿.Associated complaint (b)(4) /3001845648-2024-00076 is being cancelled, based on product managers input that no user error occurred.Manufacturing records prior to distribution all devices are subjected to a visual inspection and functional inspection to ensure device integrity.A review of the manufacturing records of lot c1465258 did not reveal any discrepancies that could have contributed to this complaint issue.Review historical data he review of relevant manufacturing records of lot number c1465258 confirms the failure mode has not previously occurred for this work order.Instructions for use and/label the instructions for use, ifu0061 which accompanies this device, instructs the user that ¿¿ 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 of stent into adjacent vascular structures , esophageal ulceration and erosion, esophagitis, fistula involving trachea, 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, reclusion, sensitivity to metal components, sepsis, stent misplacement and/or migration, tracheal obstruction , tumour over growth and wire entrapment.There is no 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 a definitive root cause could not be determined.It is possible that extrinsic hard tumour expression could have led to inadequate stent expansion.It is known from the available information that the stent was used to treat a malignant extrinsic obstruction.It is likely the stent migrated due to the inadequate stent expansion therefore the customer would have had no choice but to reposition the stent.Confirmation of 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 inadequate stent expansion was reported 26 days post stent placement.Confirmed quantity of 1 device, confirmed used.According to the pmcf study the stent was repositioned 26 days post placement.The stent remained in place at 6 months post placement or at the time of death.Investigation findings conclude that the extrinsic hard tumour expression could have led to the inadequate stent expansion reported.
Event or Problem Description
Supplemental correction report is being submitted following a review of this complaint file.Correction report scheduled to include update to investigation - evaluation notes.

• 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: 18099898
• Report Number: 3001845648-2023-00823
• Device Sequence Number: 5698276
• Product Code: ESW
• UDI-Device Identifier: 10827002480312
• UDI-Public: (01)10827002480312(17)200320(10)C1465258
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 06/07/2024

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: 03/20/2020
• Device Catalogue Number: EVO-20-25-10-E
• Device Lot Number: C1465258
• 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): Follow-Up
• Initial Date Received by Manufacturer: 10/12/2023
• Supplement Date Received by Manufacturer: 10/12/2023; 10/12/2023
• Initial Report FDA Received Date: 11/09/2023
• Supplement Report FDA Received Date: 03/07/2024; 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2018
• 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 Age: 76 YR
• Patient Sex: Female
• Patient Weight: 41 KG