MAUDE Adverse Event Report: COOK IRELAND LTD. EVOLUTION COLONIC CONTROLLED-RELEASE STENT-UNCOVERED; MQR STENT, COLONIC METALLIC EXPANDABLE

Catalog Number EVO-25-30-8-C

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Migration (2249)

Event Type  malfunction  

Event Description

Post procedure, the user noted the stent had migrated.Stent remains in patient as intended.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.Although requested no further additional information was received in relation to this complaint event.

Manufacturer Narrative

This complaint report meets the reporting criteria of an fda mdr report based on the reporting precedence established for this product family for "stent migration", regardless of patient outcome.The complaint description provided was as follows: "post procedure, the user noted the stent had migrated." the stent remains in patient as intended.The patient did not require any additional procedures due to this occurrence.Requests have been made for additional information but this has not been provided to date.As the lot number of the evo-25-30-8-c (evolution) device involved in this complaint was not provided, it was not possible to determine if there were any devices of the same lot number in stock at cook ireland.The device involved in the complaint was not returned for evaluation.With the information provided, a document based investigation was carried out.A possible cause of stent migration may be that the stent was not placed symmetrically with the stricture.This could lead to migration as the stent would not have as much anchorage as it would have had if it was placed symmetrically with both flanges external to the lesion.Other potential causes of stent migration are if the stent was placed beyond the structure or if an incorrect sized stent was selected.As per the "precautions" referenced in the instructions for use that accompanies this device, ifu0052-8: "a complete diagnostic evaluation must be performed prior to use to determine proper stent size." the "selection of stent" section of the ifu states "a stent length of at least 4cm longer than the stricture is recommended (i.E.At least 2cm longer at either end of stricture)", the ifu also advices the user to confirm desired stent position fluoroscopically prior to deploying the stent.As the device involved in the complaint was not returned for evaluation and as actual use conditions cannot be replicated in the laboratory, the cause of the complaint could not be conclusively determined.The complaint is considered confirmed based on the customer testimony.Prior to distribution evolution devices are subjected to a visual inspection and functional checks to ensure device integrity.A review of the manufacturing records for the evolution device involved in this complaint was not possible as the lot number was not provided.Evolution devices are used for palliative treatment for colonic obstruction or colonic strictures caused by malignant neoplasms, and to relieve large bowel obstruction prior to colectomy in patients with malignant strictures.Potential complications referenced in ifu0052-8 associated with upper gi endoscopy include stent misplacement and/or migration.The complaint information confirmed that the patient experienced no adverse effects as a result of this occurrence.The stent remains in the patient and the patient did not require any additional procedures due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: EVOLUTION COLONIC CONTROLLED-RELEASE STENT-UNCOVERED
• Type of Device: MQR STENT, COLONIC METALLIC EXPANDABLE
• Manufacturer (Section D): COOK IRELAND LTD.; limerick ; EI
• Manufacturer Contact: tracy sullivan, unk ; 61334440
• MDR Report Key: 4023004
• MDR Text Key: 4729520
• Report Number: 3001845648-2014-00058
• Device Sequence Number: 1
• Product Code: MQR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113510
• 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: 03/03/2014

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 Catalogue Number: EVO-25-30-8-C
• 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: 03/03/2014
• Initial Date FDA Received: 07/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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