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

Catalog Number EVO-22-27-6-D

Device Problems Fracture (1260); Activation, Positioning or Separation Problem (2906)

Patient Problem Surgical procedure, additional (2564)

Event Date 05/06/2014

Event Type  Injury  

Event Description

During a duodenal stent placement, after the stent was partially deployed, the stent could no longer be advanced or drawn back.The catheter had to be cut.Once the catheter was cut, the stent released and landed improperly.The stent began to unravel inside the patient, and the procedure was ended.A second procedure was scheduled to remove the unraveled stent.Stent removal was unsuccessful.A second stent was placed successfully inside the unraveled stent.The unraveled stent remains inside the patient.The second stent placed remains inside the patient.No adverse effects to the patient have currently been reported as occurring.

Manufacturer Narrative

There was no evo-22-27-6-d device of lot c888409 in stock at the time of the investigation.The evolution introducer/delivery system involved in this complaint was not available to be returned for evaluation.The stent remains in the patient.Two images of the stent were provided.Images of the evolution introducer/delivery system have been requested and have not yet been provided.With the information provided a document based investigation was carried out.The complaint information reported was as follows: "during a duodenal stent placement, after the stent was partially deployed, the stent could no longer be advanced or drawn back.The catheter had been cut.Once the catheter was cut, the stent released and landed improperly.The stent began to unravel inside the patient, and the procedure was ended.A second procedure was scheduled to remove unraveled stent.Stent removal was unsuccessful.A second stent was placed successfully inside of the unraveled stent." based on the images of the stent provided, the customer complaint could be confirmed as the stent was unravelled.The relevant product development personnel and product manager attempted to replicate the issue in the laboratory by fully deploying an evo-22-27-12-d device.When the stent was fully deployed and the safety wire in place, and an attempt was made to recapture the stent, this resulted in the stent becoming damaged.It was also observed that the tip of the catheter was damaged as a result.However, it may be noted that the user has indicated they removed the safety wire during this incidence.As the device was not returned, we are unable to conclusively determine the cause of this complaint.Prior to distribution, all evo-22-27-6-d devices are subjected to visual inspection and functional checks to ensure device integrity.A review of the manufacturing records for evo-22-27-6-d of lot c888409 did not reveal any discrepancies that could have contributed to this issue.The instructions for use, ifu, instructs the user of the following step 10: "when stent point of no return has been passed.Pull safety wire out of delivery handle near wire guide port.Step 11 continue deploying stent by squeezing trigger.Step 12 after deployment, fluoroscopically confirm pull stent expansion.Once full expansion is confirmed, introduction system can be safely removed.From the information provided, the unraveled stent remains inside the patient.A second stent was placed successfully inside of the unraveled stent.The patient has not experienced any further adverse effects due to this occurrence.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, METALLIC EXPANDABLE, DUODENAL
• Manufacturer (Section D): COOK IRELAND LTD; limerick ; EI
• Manufacturer Contact: tracy o'sullivan ; 61334440
• MDR Report Key: 3888025
• MDR Text Key: 4652444
• Report Number: 3001845648-2014-00096
• Device Sequence Number: 1
• Product Code: MUM
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: Physician
• Type of Report: Initial
• Report Date: 05/06/2001,05/06/2014

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: 05/28/2015
• Device Catalogue Number: EVO-22-27-6-D
• Device Lot Number: C888409
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/06/2014
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/07/2014
• Initial Date FDA Received: 06/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2013
• 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