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 Problems Break (1069); Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/12/2017

Event Type  Injury  

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-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 (b)(4).A review of the manufacturing records for this evolution device of lot c1169388 did not reveal any discrepancies in the manufacturing records 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

As reported to customer relations: "the evolution® duodenal controlled-release stent was placed and deployed correctly.When the catheter was being withdrawn a small piece of wire had fallen off inside the patient's bowel, duodenum.Using forceps, the doctor removed the wire.The stent was left in place and no harm was reported to the patient.".

Manufacturer Narrative

(b)(4).Importer site contact and address: (b)(4).Importer site establishment registration number: (b)(4).It was originally indicated that the device involved in this complaint was not being returned to cook (b)(4) for evaluation; however the device was returned on 07-feb-2017.One x evo-22-27-9-d device of lot number c1169388 was returned for evaluation.It was observed during the device evaluation that the lock wire had been fully removed and was returned with the device.No damage was evident on the lockwire.There were 2 kinks evident on the polyimide.One piece of wire from the stent was returned.The od of the piece of stent wire was approximately 0.199mm.The length of the piece of stent wire was approximately 18/19mm.The cirl r & d engineer commented that it is assumed that it was the proximal end of the stent that broke.A definitive cause for the reported issue was unable to be determined as the actual use conditions could not be duplicated in the laboratory setting.The customer complaint was confirmed as a piece of the broken stent (stent wire) was returned concluding breakage of the stent.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.A review of the manufacturing records for this evolution device of lot c1169388 did not reveal any discrepancies in the manufacturing records 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

As reported to customer relations: "the evolution® duodenal controlled-release stent was placed and deployed correctly.When the catheter was being withdrawn a small piece of wire had fallen off inside the patient's bowel, duodenum.Using forceps, the doctor removed the wire.The stent was left in place and no harm was reported to the patient.".

• 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: tracy o'sullivan ; o'halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 6313680
• MDR Text Key: 66860534
• Report Number: 3001845648-2017-00041
• Device Sequence Number: 1
• Product Code: MUM
• UDI-Device Identifier: 10827002480268
• UDI-Public: (01)10827002480268(17)171106(10)C1169388
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/14/2017

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/13/2017
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/13/2017
• Initial Date FDA Received: 02/09/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2015
• 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 Outcome(s): Required Intervention