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  

Manufacturer Narrative

Pma/510(k) # k162717 investigation is still ongoing - a final mdr will be submitted within the required timeframe.

Event Description

Per page 17 patient received chemo after placement ¿ additional file required as it is a user error to administer chemo after placement.

Manufacturer Narrative

Pma/510(k) #k162717.Supplemental cancellation report is being submitted due to clinical confirming on 27-nov-2023 that there was no user error of chemotherapy being administered post placement as the stent was removed prior to this treatment being administered.As a result the incident does not meet the criteria an fda ¿serious injury¿ report or ¿malfunction¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿.Therefore this file will be cancelled and the complaint event will be captured in (b)(4).

Event Description

Supplemental cancellation report is being submitted due to clinical confirming on 27-nov-2023 that there was no user error of chemotherapy being administered post placement as the stent was removed prior to this treatment being administered.As a result the incident does not meet the criteria an fda ¿serious injury¿ report or ¿malfunction¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿.Therefore this file will be cancelled and the complaint event will be captured in (b)(4).

• 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: 17697862
• MDR Text Key: 322813410
• Report Number: 3001845648-2023-00679
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/03/2024

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 Catalogue Number: EVO-20-25-10-E
• Device Lot Number: C1515329
• 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: 08/10/2023
• Initial Date FDA Received: 09/07/2023
• Supplement Dates Manufacturer Received: 08/10/2023
• Supplement Dates FDA Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 67 YR
• Patient Sex: Male
• Patient Weight: 104 KG