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 Activation, Positioning or Separation Problem (2906)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).As the device was not returned for evaluation; the cause of this complaint could not be conclusively determined.With the information provided a document based investigation was carried out.The customer complaint is considered to be confirmed based on customer testimony.Prior to distribution all evo-25-30-8-c devices are subjected to visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at (b)(4).Upon review of complaints this failure mode has not occurred previously with this lot # c1247787.The instructions for use which accompanies this device instructs the user to "visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use".From the information provided, there have been no adverse effects to the patient as a result of this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

An evo-25-30-8-c ((b)(4)) was used but failed.After the initial device failure, an evo-25-30-10-c ((b)(4)) was used but also failed.A third device was used successfully.Update received 31jan2017: the patient had ovarian cancer and the stent was used for extrinsic compression in the recto-sigmoid union.The physician inserted the device through the wire guide which was previously inserted through the stricture without any problem, then the doctor made sure that the position button was in the correct placement in the device, then he proceeded to pull the trigger.Upon pulling the trigger, the stent was starting to came out of the system, the indicator button reached the ¿no return point¿ and it seems to be alright so he pull the safety wire guide and continue pulling the trigger but the stent was not deployed completely it was just about 60% although he pull the trigger till the end of the system.(this report) after that the physician decided to insert a brand new stent.The wire guide stayed in place, meanwhile, he changed the stent and proceed to start again, but this time the doctor decided not pull the ¿safety wire guide¿ when the indicator button reached the ¿no return point¿.When the indicator button reached the end of the system, the stent was deployed just around 50% again, so he tried to retrieved the stent but this maneuver wasn¿t successful and finally there was an audible snap at which point the stent would not continue to advance in any direction.At this time the stent was removed and a new one stent was used without any incident.(ref # 3001845648-2017-00057).Per reporter 31jan2017, "the stent never came out completely from the deployment system, so the doctor pulled out the all system doing long wire exchange".

Manufacturer Narrative

Cook ireland ltd (manufacturer) is submitting this report on behalf of (b)(4).Information pertaining to (b)(6).Importer site establishment registration number: (b)(4).Upon evaluation of the returned device, it was noted that the device was badly damaged from the chlorine that was used to sterilize it prior to return.The lockwire was present and in place.The flexor had stretched.Deployment was not possible.The remaining part of the stent was pulled out from the sheath, the flange of the stent was missing when pulled out.As per rep info provided on attempting to sterilize with chlorine - ' the stent was dissolved'.Therefore, it is assumed that the flange of the stent dissolved as a result of them attempting to sterilize the device with chlorine.The customer complaint was confirmed as the flexor was stretched.Prior to distribution all evo-25-30-8-c devices are subjected to visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.Upon review of complaints this failure mode has not occurred previously with this lot # c1247787.The instructions for use which accompanies this device instructs the user to "visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use".From the information provided, there have been no adverse effects to the patient as a result of this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

This follow up is due to be submitted as the device was returned to cirl.An evo-25-30-8-c (pr172470) was used but failed.After the initial device failure, an evo-25-30-10-c (pr172463) was used but also failed.A third device was used successfully.Update received 31jan2017: the patient had ovarian cancer and the stent was used for extrinsic compression in the recto-sigmoid union.The physician inserted the device through the wire guide which was previously inserted through the stricture without any problem, then the doctor made sure that the position button was in the correct placement in the device, then he proceeded to pull the trigger.Upon pulling the trigger, the stent was starting to came out of the system, the indicator button reached the ¿no return point¿ and it seems to be alright so he pull the safety wire guide and continue pulling the trigger but the stent was not deployed completely it was just about 60% although he pull the trigger till the end of the system.(this report) after that the physician decided to insert a brand new stent.The wire guide stayed in place, meanwhile, he changed the stent and proceed to start again, but this time the doctor decided not pull the ¿safety wire guide¿ when the indicator button reached the ¿no return point¿.When the indicator button reached the end of the system, the stent was deployed just around 50% again, so he tried to retrieved the stent but this maneuver wasn¿t successful and finally there was an audible snap at which point the stent would not continue to advance in any direction.At this time the stent was removed and a new one stent was used without any incident.(ref # 3001845648-2017-00057) per reporter (b)(6) 2017, "the stent never came out completely from the deployment system, so the doctor pulled out the all system doing long wire exchange".

• Brand Name: EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED
• Type of Device: MQR STENT, COLONIC METALLIC EXPANDABLE
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer Contact: tracy o'sullivan ; o'halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 6345463
• MDR Text Key: 68089068
• Report Number: 3001845648-2017-00056
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 10827002480282
• UDI-Public: (01)10827002480282(17)180704(10)C1247787
• Combination Product (y/n): N
• PMA/PMN Number: K113510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2017
• 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?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/21/2017
• Event Location: Hospital
• Date Manufacturer Received: 01/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/04/2016
• 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