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

Model Number G48025

Device Problem Delivery System Failure (2905)

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

Event Date 12/05/2017

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".A patient who had duodenal bulb stricture underwent deodenal stent placement.The endoscope (olympus/gif-2t240) was inserted, and the wire guide (0.035 inch) was placed.Then, delivery system was inserted into the desired lesion.The physician held the endoscope and the nurse held the delivery system and attempted to deploy the stent.When the nurse attempted to deploy the stent by squeezing the handle, the stent did not start deployment.Then, the sheath got separated from the handle therefore the stent would not be deployed.The delivery system was removed from the patient's body and it was replaced with another device (9 cm) to complete the procedure without problems.

Manufacturer Narrative

Pma/510(k) # "k101530 and k163468." (b)(4).Exemption number: e2016031.(b)(4).Problem statement: the customer reported the following complaint: ¿a patient who had duodenal bulb stricture underwent duodenal stent placement.The endoscope (olympus/gif-2t240) was inserted, and the wire guide (0.035 inch) was placed.Then, delivery system was inserted into the desired lesion.The physician held the endoscope and the nurse held the delivery system and attempted to deploy the stent.When the nurse attempted to deploy the stent by squeezing the handle, the stent did not start deployment.Then, the sheath got separated from the handle therefore the stent would not be deployed.The delivery system was removed from the patient's body and it was replaced with another device (9cm) to complete the procedure without problems.¿ device evaluation: the evo-22-27-6-d device of lot number c1270252 was not returned to (b)(4) for evaluation.With the information provided a document based investigation was carried out.The patient had the following pre-existing condition: duodenal bulb stricture the following additional information was received from the cook representative: no image will be available for review.The patient condition was doing well after another stent was placed.The patient has been discharged.1) was the stent partially deployed or not at all? not at all 2) where did the sheath separate? the sheath got separated from the handle 3) did the patient require intervention or any additional procedures as a result of this incident? no.The complaint device was just replaced with another size (9cm) of the device.4) did the physician notice any other damage to the device or pieces broken off? no there is no evidence to suggest that this event did not occur, therefore the complaint is confirmed based on customer testimony.As the device was not returned for evaluation, and no imaging provided for review, a definite root cause of this complaint cannot be determined.However, a possible cause for the issue occurring may be due to delamination of the ptfe liner of the outer sheath.Document review: prior to distribution all evo-22-27-6-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 (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.Summary: there is no evidence to suggest that this event did not occur, therefore the complaint is confirmed based on customer testimony.No adverse events were reported as a result of this occurrence.The patient condition was doing well after another stent was placed.The patient has since been discharged.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Follow up mdr submitted to update investigation details mdr submitted based on the device malfunction precedence: ¿flexor kinked/stretched/broke/compressed".A patient who had duodenal bulb stricture underwent deodenal stent placement.The endoscope (olympus/gif-2t240) was inserted, and the wire guide (0.035 inch) was placed.Then, delivery system was inserted into the desired lesion.The physician held the endoscope and the nurse held the delivery system and attempted to deploy the stent.When the nurse attempted to deploy the stent by squeezing the handle, the stent did not start deployment.Then, the sheath got separated from the handle therefore the stent would not be deployed.The delivery system was removed from the patient's body and it was replaced with another device (9cm) to complete the procedure without problems.

Event Description

Follow up report is submitted due to corrections.A patient who had duodenal bulb stricture underwent deodenal stent placement.The endoscope (olympus/gif-2t240) was inserted, and the wire guide (0.035 inch) was placed.Then, delivery system was inserted into the desired lesion.The physician holded the endoscope and the nurse hold the delivery system and attempted to deploy the stent.When the nurse attempted to deploy the stent by squeezing the handle, the stent did not start deployment.Then, the sheath got separated from the handle therefore the stent would not be deployed.The delivery system was removed from the patient's body and it was replaced with another device (9cm) to complete the procedure without problems.

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 (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.

• 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: 7153787
• MDR Text Key: 96354384
• Report Number: 3001845648-2017-00611
• Device Sequence Number: 1
• Product Code: MUM
• UDI-Device Identifier: 10827002480251
• UDI-Public: (01)10827002480251(17)180907(10)C1270252
• 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: 12/29/2017

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: 09/07/2018
• Device Model Number: G48025
• Device Catalogue Number: EVO-22-27-6-D
• Device Lot Number: C1270252
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/29/2017
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/29/2017
• Supplement Dates Manufacturer Received: 12/29/2017; 12/29/2017
• Supplement Dates FDA Received: 01/25/2018; 06/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1