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

Model Number G48032

Device Problems Kinked (1339); Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Report is submitted under the precedence of "flexor kinked/stretched/broke/compressed".Dr.(b)(6) informed they have followed all the guide lines for intended usage.The stent could not be fully placed on the desired stricture, as the end of the stent was still attached within the catheter, after doing the full deployment.Then they had to bring out the stent & complete the procedure with our 10 cm evo-e.

Manufacturer Narrative

Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031 information pertaining (b)(4).Importer site establishment registration number: (b)(4).This follow up is being submitted to cancel the initial mdr report.A conservative approach was taken in initially assessing this complaint and was originally reported under the malfunction precedence of "deployment issue that results in the exposed stent removed from the patient with the delivery system".Additional information was received to confirm that the stent was re-captured fully prior to patient removal.A serious deterioration in the state of health of the patient was not reported in this case.Based on the information provided in this complaint, the risk has been established within the file.This event has been re-assessed and this report is to notify the fda that this event no longer meets the fda reporting criteria of a malfunction report as per section 803.50 of 21 cfr 803- overall risk assessed as category iia (low).

Event Description

This follow up report is to cancel the initial report.(b)(6) informed they have followed all the guide lines for intended usage.The stent could not be fully placed on the desired stricture, as the end of the stent was still attached within the catheter, after doing the full deployment.Then they had to bring out the stent & complete the procedure with our 10 cm evo-e.

• 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
• MDR Report Key: 7649433
• MDR Text Key: 113010076
• Report Number: 3001845648-2018-00294
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 10827002480329
• UDI-Public: (01)10827002480329(17)190512(10)C1355660
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/25/2018

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: 05/12/2019
• Device Model Number: G48032
• Device Catalogue Number: EVO-20-25-12.5-E
• Device Lot Number: C1355660
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/25/2018
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/04/2018
• Initial Date FDA Received: 06/29/2018
• Supplement Dates Manufacturer Received: 06/04/2018
• Supplement Dates FDA Received: 07/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 60