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

Model Number G48029

Device Problems Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Delivery System Failure (2905)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/25/2017

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) # k163468.(b)(4).The customer reported the following complaint issue: during a colonoscopy procedure the physician did not use the wire guide.The procedure was to place an evolution stent in the sigmoid colon.The physician deployed the stent and when deployed it turned in on itself at that point, the staff noted that the white tip and part of the introduction system had detached from the catheter.The physician removed the detached portion of the device and the stent by hand.The physician used a colonoscope during the procedure." per (b)(6), "when they deployed the stent, that one side of the stent would not open; was compressed." the (b)(6) reached out to the physician regarding scheduling an in-service on the compliant device and will schedule an in-service with staff.The (b)(6) is to confirm further details of the event and will schedule an in-service with the physician and staff.An image of the stent and the polyimide with the tip were provided for review.An image from the procedure was also provided and has been sent to clinical, product manager and engineering for review.Product manger had the following comments on imaging provided: "firstly, not using the wire guide would contradict what recommended in the ifu.Secondly, the stent looks more bunched rather than turned in on itself.I wonder if the physician and nurse were out of sync as during deployment.If not it could result in the sent bunching together." it was originally indicated that the device involved in this complaint was being returned to cook ireland for evaluation.The device was received 23-oct-17, however, the device evaluation was not completed prior to this report and the investigation will be updated.As the evaluation is in progress; the cause of this complaint could not be conclusively determined.However, from the information provided, instructions for use were not followed as there was no wire guide placed prior to introducing the device which most likely caused the cascade of issues that followed.Also, as per comments from senior product manager, it is possible that during deployment the physician and nurse may have been out of sync which resulted in the sent bunching together and further cascading issues.With the information provided a document based investigation was carried out.The customer complaint was confirmed on customer testimony; however, from the information provided this has been determined to be user error as no wire guide was placed prior to introducing the device.The senior product manager has been made aware of this incident, training has not been requested because as per information provides dm will schedule an in-service with the physician and staff.The evo-25-30-6-c device of lot history contains one unit of which was scrapped for delamination of flexor, as this unit was scrapped it would therefore not have an impact on the issue involved in this complaint, no other discrepancies were found.Prior to distribution all evo-25-30-6-c devices are subjected to a visual inspection and functional checks to ensure device integrity.A review of the manufacturing records for evo-25-30-6-c of lot number did not reveal any discrepancies that could have contributed to this issue.There is no evidence to suggest that this issue affects the entire lot, upon review of complaints this failure mode has not occurred previously with this lot.As per instructions for use, patient preparation section: place wire guide through the stricture.On review of the information provided, it would suggest that the user did not follow the instructions for use.From the information provided, did not place another stent as none was in customers stock, pt is doing okay and another stent is not needed at this time.Update: pt.Is doing fine - no stent needed at this time.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Initial mdr is being submitted based on the requirement for a surgical intervention.As reported to customer relations: " during a colonoscopy procedure the physician did not use the wire guide.The procedure was to place an evolution stent in the sigmoid colon.The physician deployed the stent and when deployed it turned in on itself at that point, the staff noted that the white tip and part of the introduction system had detached from the catheter.The physician removed the detached portion of the device and the stent by hand.The physician used a colonoscope during the procedure." per (b)(6), "when they deployed the stent, that one side of the stent would not open; was compressed." the dm reached out to the physician regarding scheduling an in-service on the compliant device and will schedule an in-service with staff.The (b)(6) is to confirm further details of the event and will schedule an inservice with the physician and staff.

Manufacturer Narrative

Pma/510(k) # k163468.Cook ireland ltd (manufacturer) is submitting this report on behalf of (b)(4).Exemption number: e2016031.(b)(4).The stent and polyimide wire with white tip were returned to cirl for evaluation, deployment system was not returned.Upon evaluation of the returned device, it was noted only the stent fully deployed and the polyimide wire with the white tip attached were returned for evaluation.The full length of the polyimide wire was accounted for in the returned piece.There was stretching evident on the polyimide.No defects were noted with the stent.The complaint is confirmed based on the customers testimony as the clinical setting that could impact on the functionality of the device cannot be replicated in the laboratory.As the full device was not returned for evaluation; the cause of this complaint could not be conclusively determined.However, from the information provided, instructions for use were not followed as there was no wire guide placed prior to introducing the device which most likely caused the cascade of issues that followed.Also, as per comments from senior product manager, it is possible that during deployment the physician and nurse may have been out of sync which resulted in the stent bunching together and further cascading issues.Senior product manager has been made aware of this incident, training has not been requested because as per information provided dm will schedule an inservice with the physician and staff.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

This follow up mdr is being submitted due to the complaint device being returned and device evaluation.As reported to customer relations: "during a colonoscopy procedure the physician did not use the wire guide.The procedure was to place an evolution stent in the sigmoid colon.The physician deployed the stent and when deployed it turned in on itself at that point, the staff noted that the white tip and part of the introduction system had detached from the catheter.The physician removed the detached portion of the device and the stent by hand.The physician used a colonoscope during the procedure." (edited by ar 27spet2017 per phone conversation with dm).Per dm, "when they deployed the stent, that one side of the stent would not open; was compressed." the dm reached out to the physician regarding scheduling an in-service on the compliant device and will schedule an in-service with staff.Ar 27sept2017.The district manager is to confirm further details of the event and will schedule an inservice with the physician and staff.Th 27sept2017.

• Brand Name: EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED
• 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: 6971082
• MDR Text Key: 90038271
• Report Number: 3001845648-2017-00483
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 10827002480299
• UDI-Public: (01)10827002480299(17)190209(10)C1324713
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113510
• 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: 10/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: G48029
• Device Catalogue Number: EVO-25-30-6-C
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/26/2017
• Event Location: Hospital
• Date Manufacturer Received: 10/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2017
• 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 Outcome(s): Required Intervention