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

Model Number G48026

Device Problem Delivery System Failure (2905)

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

Event Date 12/01/2017

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) # "k101530 and k163468" (b)(4).Investigation pending, a follow up mdr will be submitted with the investigation conclusions.

Event Description

Initial mdr is being submitted based on the device malfunction precedence: ¿flexor kinked/stretched/broke/compressed".As reported to customer relations "upon deploying the stent, the assembly of the trigger was showing that the stent had been deployed but in actuality it had not deployed.The stent was eventually deployed upon the physician breaking the handle open and making it a push/pull deployment system.

Event Description

Follow up report submitted to update investigation findings.Mdr submitted based on the device malfunction precedence: ¿flexor kinked/stretched/broke/compressed".As reported to customer relations "upon deploying the stent, the assembly of the trigger was showing that the stent had been deployed but in actuality it had not deployed.The stent was eventually deployed upon the physician breaking the handle open and making it a push/pull deployment system.

Manufacturer Narrative

Pma/510(k) # "k101530 and k163468" (b)(4).Exemption number: e2016031 (b)(4).As reported to customer relations "upon deploying the stent, the assembly of the trigger was showing that the stent had been deployed but in actuality it had not deployed.The stent was eventually deployed upon the physician breaking the handle open and making it a push/pull deployment system.The evo-22-27-9-d stent of lot number c1337420 was implanted in the patient and is therefore unavailable for evaluation.The delivery system was thrown away.With the information provided a document based investigation was carried out.The patient had the following pre-existing condition: outlet obstruction the following additional information was received from the cook representative: what is the reorder number of the wire guide used with this device? -met 2 if not, with the device in question, how was the procedure finished? -device in question what is the endoscope manufacturer and model number that was used during the procedure? -olympus 1t 160 had dilation of the stricture been performed prior to stent placement? -no what was the diameter of the stricture at the time of stent placement (in mm)? -unknown (large enough for endoscope to fit through) what was the length of the stricture at the time of stent placement (in cm)? -about 5 cm please describe the location in the body where the stent was to be placed.-2nd portion duodenum was resistance encountered when advancing the wire guide through the stricture? -no was resistance encountered when advancing the introducer and stent into position? -no did any section of the device detach inside the patient? -no was the stent partially deployed when removed from the patient? -it was not removed.After placement, was stent position verified? -yes if yes, please describe how.-endoscopically and fluoroscopically after placement, was the endoscope advanced through the stent? -yes, until it met resistance.Please estimate amount of time the stent was in place prior to this occurrence.-this occurred during placement.Did the patient undergo chemotherapy or radiation treatments after stent placement? ¿unknown there is no evidence to suggest that this event did not occur, therefore the complaint is confirmed based on customer testimony.A possible cause for the issue occurring may be due to delamination of the ptfe liner of the outer sheath 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 cook (b)(4).A review of the qc records did not reveal any issues which could have contributed to this complaint issue.Upon review of complaints this failure mode has not occurred previously with this lot number.Based on information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number.As per the instructions for use, 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 viable evidence to suggest that the user did not follow the instructions for use.There is no evidence to suggest that this event did not occur, therefore the complaint is confirmed based on customer testimony.There were no adverse events reported as a result of this occurrence.

Manufacturer Narrative

Pma/510(k) # "k101530 and k163468".Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (b)(6).Cook medical incorporated (cmi) (b)(4).Importer site establishment registration number: (b)(4).This report is being submitted due corrections: it may be noted that a project has been assigned to product development to further investigate stent deployment issues of this nature in an effort to eliminate future occurrences.

Event Description

Follow up report is being submitted due to corrections.As reported to customer relations "upon deploying the stent, the assembly of the trigger was showing that the stent had been deployed but in actuality it had not deployed.The stent was eventually deployed upon the physician breaking the handle open and making it a push/pull deployment system.

• 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
• MDR Report Key: 7150483
• MDR Text Key: 96370013
• Report Number: 3001845648-2017-00625
• Device Sequence Number: 1
• Product Code: MUM
• UDI-Device Identifier: 10827002480268
• UDI-Public: (01)10827002480268(17)190316(10)C1337420
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 12/01/2017

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/16/2019
• Device Model Number: G48026
• Device Catalogue Number: EVO-22-27-9-D
• Device Lot Number: C1337420
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/01/2017
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/04/2017
• Initial Date FDA Received: 12/28/2017
• Supplement Dates Manufacturer Received: 12/28/2017; 12/04/2017
• Supplement Dates FDA Received: 01/25/2018; 06/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1