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

Catalog Number EVO-25-30-10-C

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 08/11/2016

Event Type  malfunction  

Manufacturer Narrative

It was indicated that the complaint device will be returned for evaluation to (b)(4), the device has not yet been received at (b)(4), however, upon receipt of the complaint device, it will be evaluated and the investigation will be updated.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-25-30-10-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).There is no evidence to suggest that this issue affects the entire lot # c1190452; upon review of complaints this failure mode has not occurred previously with this lot # c1190452.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

After the delivery system was introduced to the target, the physician found the stent couldn't release completely, and also fail to withdraw.Then the physician removed the device and changed to a new stent to finish the procedure successfully.Fda mdr 'malfunction' reporting criteria met based on a malfunction reporting precedence established for this device family.

Manufacturer Narrative

Approx 1 x evo-25-30-10-c device of c1190452 was returned for evaluation.On evaluation of the returned device, it was noted that the stent was partially deployed.The lockwire was protruding from the handle.There was a kink evident in the polyimide.Actuation was possible but deployment was not.The device was dismantled; no issues were noted with the flexor.The handle cannula was broken, it buckled and then broke.The stent was manually deployed and noted to be okay.The first buckle point was 20cm from the distal end of the handle cannula.The customer complaint is confirmed as the handle cannula was broken and deployment was not possible.Prior to distribution all evo-25-30-10-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).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".A review of the manufacturing records for evo-25-30-10-c device of lot# c1190452 did not reveal any discrepancies that could have contributed to this complaint issue.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 is a follow-up report due to the return and evaluation of the device.After the delivery system was introduced to the target site, the physician found the stent couldn't release completely, and also fail to withdraw.Then the physician remove out the device and change a new stent to finish the procedure successfully.Fda mdr 'malfunction' reporting criteria met based on a malfunction reporting precedence established for this device family.

• 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: sinead quaid ; o halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 5948678
• MDR Text Key: 54627070
• Report Number: 3001845648-2016-00260
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 10827002480381
• UDI-Public: (01)10827002480381(17)180113(10)C1190452
• Combination Product (y/n): N
• Reporter Country Code: CN
• 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: 09/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: EVO-25-30-10-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: 08/11/2016
• Event Location: Hospital
• Date Manufacturer Received: 09/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2016
• 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
• Patient Age: 43 YR
• Patient Weight: 63