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

Catalog Number EVO-22-27-12-D

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Type  malfunction  

Event Description

During initial deployment, the delivery mechanism failed as it snapped.The endoscope was in a severe bend.The physician elected to open a boston scientific duodenal stent to complete the procedure.Additional information received confirmed the safety wire had snapped.A section of the device did not remain inside the patient's body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

This incident meets the reporting criteria of an fda mdr report based on the reporting precedence established for this product family for safety wire breakage; regardless of patient outcome.The device has not been returned for evaluation; therefore, a document based investigation was carried out.As the device has not been returned the cause of the complaint could not be conclusively determined.Additional information received from the sales rep indicated the safety wire snapped during the initial phase of deployment while the introducer was inside the patient, the stent did not deploy.The endoscope was in a severe bent position and on the first few squeezes resistance was encountered and they then heard a snap.No photos were available as the device was discarded.A possible cause for the safety wire snapping could be the force used when removing it from the introducer.However, as the device was not returned for evaluation the cause of the complaint could not be conclusively determined.A review of the manufacturing instructions revealed no discrepancies that could have contributed to this complaint.There is a 100% inspection performed on all evo-22-27-12-d devices.As per instructions for use, there are specific instructions for the user on stent deployment.Prior to distribution, all evolution devices are subjected to final functional checks and visual inspection to ensure integrity of the product.The customer complaint could be confirmed based on customer testimony.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 sullivan, unk ; 61334440
• MDR Report Key: 4128762
• MDR Text Key: 21245620
• Report Number: 3001845648-2014-00174
• 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: Other
• Type of Report: Initial
• Report Date: 08/26/2014

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: 05/23/2016
• Device Catalogue Number: EVO-22-27-12-D
• Device Lot Number: C1001582
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/26/2014
• Initial Date FDA Received: 09/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2014
• 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