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

Catalog Number EVO-20-25-10-E

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event 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.

Manufacturer Narrative

Pma/510(k) # k162717.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

• Brand Name: EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY 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: 18795537
• MDR Text Key: 337623989
• Report Number: 3001845648-2024-00076
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/01/2024

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
• Device Operator: 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
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 02/01/2024
• Initial Date FDA Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2018
• 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 Age: 76 YR
• Patient Sex: Female
• Patient Weight: 41 KG