MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED; MUM STENT, METALIC EXPANDABLE, DUODENAL

Model Number G48025

Device Problem Difficult to Advance (2920)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 11/04/2019

Event Type  malfunction  

Manufacturer Narrative

510(k)#: k163468 investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

The stent was put down into the patient, but would not deploy.Procedure was completed using another stent."as per complaint form"; staff advised the stent was in position over the guidewire and when they removed the red indicator tab to squeeze the trigger the stent failed to deply at all.Another stent was used to complete the procedure.

Manufacturer Narrative

510(k)#: k163468.Lab evaluation completed on 05-dec-2019 that confirmed the flexor did not kink/break.This file was initially assessed as "flexor kinked/broken" which is a malfunction precedence.This file has been re-assessed based on the lab evaluation details and no longer meets the fda mdr reporting criteria of a malfunction report.

Event Description

This report is being submitted to cancel the initial report submitted based on the receipt of additional information.

• Brand Name: EVOLUTION DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED
• Type of Device: MUM STENT, METALIC EXPANDABLE, DUODENAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9443471
• MDR Text Key: 220011044
• Report Number: 3001845648-2019-00699
• Device Sequence Number: 1
• Product Code: MUM
• UDI-Device Identifier: 10827002480251
• UDI-Public: (01)10827002480251(17)201231(10)C1571377
• 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: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: G48025
• Device Catalogue Number: EVO-22-27-6-D
• Device Lot Number: C1571377
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/04/2019
• Event Location: Hospital
• Date Manufacturer Received: 11/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1