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

Catalog Number EVO-22-27-9-D

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 08/04/2016

Event Type  Injury  

Manufacturer Narrative

The device involved in this complaint was not available for return to cook ireland for evaluation.A review of the imaging provided, it can be seen that on (b)(6) 2016 when the stent was implanted there was no damage to the stent.The follow up images on (b)(6) 2016 show breakage of the stent.This may have occurred as a result of fatigue caused by peristaltic motion in the duodenal tract.With the information provided a document based investigation was carried out.The customer complaint is considered to be confirmed based on customer testimony and images provided.As the lot number was not provided, a review of manufacturing instructions could not be complete.Prior to distribution all evo-22-27-9-d 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.As per instructions for use ¿visually inspect with particular attention to kinks, bend and breaks.If an abnormality is detected that would prohibit proper working condition, do not use.¿ from the information provided, there have been adverse effects to the patient as a result of this occurrence, ¿hematin was found in gastric antrum¿.Clinical input was received to clarify this: ¿hematin-a blue to blackish-brown compound, (b)(4), formed in the decomposition of hemoglobin.This would suggest bleeding had occurred at some point.¿ complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

The evolution stent was implanted on the (b)(6) 2016.A follow up check occurred on (b)(6) 2016.During the follow up check it turned out that the proximal crown ends of the evolution stent were split and the bare ends of wires were looming into the patients gastric tract.The broken crowns were at the proximal end of the stent localized in the antrum and the bare wire ends were protruding into the patients stomach.

• Brand Name: EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED
• Type of Device: MUM STENT, METALIC EXPANDABLE, DUODENAL
• 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: 5913251
• MDR Text Key: 53446469
• Report Number: 3001845648-2016-00231
• Device Sequence Number: 1
• Product Code: MUM
• Combination Product (y/n): N
• PMA/PMN Number: K101530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/04/2016

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: EVO-22-27-9-D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/04/2016
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/05/2016
• Initial Date FDA Received: 08/30/2016
• 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