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 Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/16/2015

Event Type  malfunction  

Manufacturer Narrative

Incident meets reporting criteria of an mdr report based on the reporting precedence established for this device family for 'stent fracture'.This complaint relates to an evo-22-27-9-d device of lot #c1020125.The device was not available to be returned for evaluation as the stent remains implanted in the patient.With the information provided a document based investigation was carried out.The customer complaint was confirmed based on customer testimony and images received.Prior to distribution, all evo-22-27-9-d devices are subjected to a visual inspection and functional checks to ensure device integrity.A review of the manufacturing records for evo-22-27-9-d device of lot number c1020125 did not reveal any discrepancies that could have contributed to this complaint issue.The notes section of instructions for use 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".Complaints of this nature will continue to be monitored for potential emerging trends.Incident meets reporting criteria of an mdr report based on the reporting precedence established for this device family for 'stent fracture'.This complaint relates to an evo-22-27-9-d device of lot#c1020125.The device was not available to be returned for evaluation as the stent remains implanted in the patient.With the information provided a document based investigation was carried out.The customer complaint was confirmed based on customer testimony and images received.Prior to distribution, all evo-22-27-9-d devices are subjected to a visual inspection and functional checks to ensure device integrity.A review of the manufacturing records for evo-22-27-9-d device of lot number c1020125 did not reveal any discrepancies that could have contributed to this complaint issue.The notes section of instructions for use 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".Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Patient got repeated vomiting and other uncomfortable symptoms after implanted the stent for three months.The physician did the endoscopy for patient and found the wire of stent (near to the proximal end) was broken/fractured.

Manufacturer Narrative

The device was not available to be returned for evaluation as the stent remains in the patient.With the information provided a document based investigation was carried out.The cirl research & development engineer provided the following comments in relation to this complaint: "the stent was in the patient for approx 3 months.It can be observed that one of the stent crowns (located in the antrum of the stomach) was broken in the images provided.The devices were not returned for further investigation.The most likely cause of failure is due to a combination of stomach acid and repeated mechanical forces leading to fatigue of the wire.It cannot be determined if the failure mode was exacerbated by clinical conditions." the customer complaint was confirmed based on customer testimony and the images received.Prior to distribution, all evo-22-27-9-d devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.A review of the manufacturing records for evo-22-27-9-d device of lot number c1020125 did not reveal any discrepancies that could have contributed to this complaint issue.The notes section of instructions for use 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".Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Patient got repeated vomiting and other uncomfortable symptoms after implanted the stent for three months.The physician did the endoscopy for patient and found the wire of stent (near to the proximal end) was broken/fractured.Incident meets reporting criteria of an mdr report based on the malfunction precedence established for this device family for 'stent fracture'.

• 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: 5167989
• MDR Text Key: 28919546
• Report Number: 3001845648-2015-00209
• Device Sequence Number: 1
• Product Code: MUM
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K101530
• 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: 11/12/2015

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-22-27-9-D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/16/2015
• Event Location: Hospital
• Initial Date Manufacturer Received: 09/25/2015
• Initial Date FDA Received: 10/22/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2014
• 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
• Patient Age: 63 YR