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 Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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".This file will capture user error of the stent being repositioned 26 days post placement.Patient outcome; 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.
Event or Problem Description
Cancellation report is being submitted due to the receipt of clarification from the product manager that there was no case of user error.It is likely that the stent migrated due to the inadequate stent expansion reported, therefore the customer would have had no choice but to reposition the stent.This complaint is no longer required.Reference pr # (b)(4)/ mdr (b)(4) device issue: inadequate stent expansion.
Additional Manufacturer Narrative
Pma/510(k) # k162717 cancellation report is being submitted due to the receipt of clarification from the product manager that there was no case of user error.It is likely that the stent migrated due to the inadequate stent expansion reported, therefore the customer would have had no choice but to reposition the stent.This complaint is no longer required.Reference pr # (b)(4)/ mdr (b)(4) device issue: inadequate stent expansion.

• 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: 18795537
• Report Number: 3001845648-2024-00076
• Device Sequence Number: 7130948
• 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
• Report Date (Section B): 06/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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): Initial
• Initial Date Received by Manufacturer: 02/01/2024
• Supplement Date Received by Manufacturer: 02/01/2024
• Initial Report FDA Received Date: 02/28/2024
• Supplement Report FDA Received Date: 07/04/2024
• 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
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 41 KG