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

Catalog Number EVO-PC-10-11-8-B

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/14/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Problem statement: evolution stent was inserted into bile duct and then deploy was attempted.Failure of stent deployment was noted.Device evaluation: the evo-pc-10-11-8-b device of lot number cf1397544 was returned to cook (b)(4) and evaluation on the 04-april-2018.Lab evaluation: upon evaluation of the returned device, it was noted that there was no stent exposure.The lockwire was returned in place.The red shuttle deployment marker was in the center of the handle.Deployment and retraction of the device was not possible.There was a kink on the flexor at approx.107.5 cm.The device was dismantled during the lab.The flexor was broken at the shuttle cap.The stent was manually deployed during the lab.The stent was noted to be okay.Customer complaint confirmed as failure was verified in laboratory.The customer complaint was confirmed as the flexor was seen to be broken at the shuttle cap during lab evaluation.Root cause: kink on the flexor possibly due to torturous path, caused a buildup of pressure and resulted in the flexor breaking at the shuttle cap.Ifu review: as per the instructions for use, ifu0057-4, notes section the user is instructed of the following: ¿visually inspect with particular attention to kinks, bends and breaks.If any abnormality is detected that would prohibit proper working condition, do not use".On review of the information provided, there is no evidence to suggest that the user did not follow the instructions for use.Documents review: prior to distribution all evo-pc-10-11-8-b 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 (b)(4).A review of the manufacturing records for evo-pc-10-11-8-b device of lot number cf1397544 did not reveal any discrepancies that could have contributed to this issue.¿deploy the stent approximately 50% and re-sheath to ensure it functions correctly.¿ ¿visual inspections of product and packaging¿ the relevant mtm is instructed to check for ¿visual irregularities such as holes, dents, kinks or tears.¿ the relevant mtms are instructed as follows: ¿inspect for visual defects; i.E.Loose or embedded foreign materials, kinks, rough or sharp edges.¿ there is no evidence to suggest that this issue affects the entire lot # cf1397544; upon review of complaints this failure mode has not occurred previously with this lot # cf1397544.Summary: customer complaint confirmed as failure was verified in laboratory.The customer complaint was confirmed as the flexor was seen to be broken at the shuttle cap during lab evaluation.From the information provided in the complaint form attached, there have been no adverse effects to the patient as a result of this occurrence.Another device was used to complete the procedure.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Evolution stent was inserted into bile duct and then deploy was attempted.Failure of stent deployment was noted.

• Brand Name: EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - PARTIALLY COVERED
• Type of Device: MQR STENT, COLONIC METALLIC EXPANDABLE
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer Contact: michael galvin ; o halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 7475218
• MDR Text Key: 107715822
• Report Number: 3001845648-2018-00199
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 10827002231402
• UDI-Public: (01)10827002231402(17)190906(10)CF1397544
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K121430
• 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: 04/04/2018

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: No Information
• Device Catalogue Number: EVO-PC-10-11-8-B
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/01/2018
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/20/2018
• Initial Date FDA Received: 05/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2017
• 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: 67 YR
• Patient Weight: 62