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

Catalog Number EVO-22-27-9-D

Device Problems Tip breakage (1638); Delivery System Failure (2905)

Patient Problem Foreign body, removal of (2365)

Event Date 03/28/2014

Event Type  Injury  

Event Description

Duodenal obstruction was observed in the pt; a metal duodenal stent was placed.Cannula with wireguide were used to cannulate.Stent was inserted and placed successfully.After the stent was well placed, there was difficulty removing the deployment system.According to the doctor and nurse, the stricture was very narrow so the bullet tip at the distal end of the deployment system became detached when forcing out.Biopsy forceps was used to retrieve the tip.A section of the device did not remain in the pt and no further adverse effects have been reported as occurring.

Manufacturer Narrative

The device involved in this complaint is currently in transit.A follow up report will be submitted following the device eval.There was no evo-22-27-9-d device of lot c924642 in stock at the time of the investigation.The device involved in this complaint is currently in transit and has not been evaluated to date.Therefore, with the info provided a document based investigation was carried out.The complaint info reported was as follows: "duodenal obstruction was observed in the pt; a metal duodenal stent was placed.Cannula with wireguide were used to cannulate.Stent was inserted and placed successfully.After the stent was well placed, there was difficulty removing the deployment system.According to the doctor and nurse, the stricture was very narrow so the bullet tip at the distal end of the deployment system became detached when forcing out.Biopsy forceps was used to retrieve the tip.A section of the device did not remain in the pt and no further adverse effects have been reported as occurring".The customer complaint could be confirmed based on customer testimony.As per the instructions for use this device, step 12: "after deployment, fluoroscopically confirm full stent expansion.Once full expansion is confirmed, introduction system can be safely removed".The user should wait for expansion of the stent before trying to remove the introduction system.For very tight strictures this may take sometime.Input received from product management concerning this complaint indicated the user most likely applied force for the tip to become detached.As the device has not been evaluated the cause of this complaint could not be conclusively determined.Prior to distribution, all evo-22-27-9-d devices are subjected to visual inspection and functional checks to ensure device integrity.A review of the mfr records for evo-22-27-9-d devices are subjected to visual inspection and functional checks to ensure device integrity.A review of the mfr records for evo-22-27-9-d of lot c924642 did not reveal any discrepancies that could have contributed to this issue.From the info provided, no section of the device remained in the pt's body.No further adverse effects to the pt have been reported as occurring.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: EVOLUTION DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED
• Type of Device: MUM STENT, METALIC EXPANDABLE, DUODENAL
• Manufacturer (Section D): COOK IRELAND LTD; limerick ; EI
• Manufacturer Contact: tracy o'sullivan ; 61334440
• MDR Report Key: 3784188
• MDR Text Key: 4361421
• Report Number: 3001845648-2014-00072
• Device Sequence Number: 1
• Product Code: MUM
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K101530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/17/2015
• Device Catalogue Number: EVO-22-27-9-D
• Device Lot Number: C924642
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/28/2014
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/31/2014
• Initial Date FDA Received: 04/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2013
• 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 Outcome(s): Required Intervention