MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER 635 BILIARY SELF EXPANDING METAL STENT; FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL

Model Number G23816

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/23/2023

Event Type  malfunction  

Event Description

The prostheses did not drop, the installation system broke."as per cc form": when the doctor wanted to deploy the stent, the delivery system broke.Patient outcome: a section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Patient/event info - notes: 1.Are images of the device or procedure available? no.2.At what stage of the procedure did the complaint occur? during stent placement.3.Was a sphincterotomy performed prior to use of the stent device? yes.4.Was balloon dilation performed prior to use of the stent device? yes.5.What was the length and diameter of the stricture? nc.6.What brand of endoscope was used with the device? duodenoscope pentax ed34i10t2 7.Was the product inspected for kinks or damage before use? yes.8.What was the position of the elevator during deployment? open.9.Was the delivery system tracked around a tight angle in the patient anatomy or around a tight angle in an endoscope? no.10.Was the device flushed through both flushing ports before the procedure, as per ifu? yes.11.Details of the wire guide used (name, diameter, hyrdophyllic)? jagwire.12.What was the target location for the stent? hile.13.Was the red safety lock removed before inserting the delivery system? no.14.Was the red safety lock removed before stent deployment? yes.15.Was the patient's anatomy tortuous? yes.16.Did the patient exhibit altered anatomy? no.17.If yes, please specify the type of altered anatomy.18.Did the patient have any pre-existing conditions? no.19.If yes, please state the specific condition(s).20.Was resistance encountered when advancing the wire guide to the target location? no.21.If yes, how did the physician deal with this resistance? 22.Was resistance encountered when advancing the delivery system to the target location? no.23.If yes, how did the physician deal with this resistance? 24.Was there resistance felt passing the delivery system through the stricture? no.25.Was any damage noted on the wire guide before, during or after the procedure? no.26.Did the tip of the delivery system cross the target location? yes.27.Was the handle pulled toward the hub during deployment? n/a.28.Was the delivery system pushed during deployment? n/a.29.Was the stent being placed through the side wall of a previously placed stent? n/a.30.Was the stent deployed smoothly / without resistance? n/a.31.Was the stent fully deployed before removing the delivery system from the patient? n/a, 32.Did any part of the product snag/get caught on the stent when removing the delivery system? n/a.33.Was post-dilation performed after the placement of the stent? n/a.34.Did the patient require any additional procedures as a result of this event? no.35.If yes, what intervention was required? 36.Was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? n/a, same procedure, another day.37.Were any other defects (other than the complaint issue) observed on the delivery system prior to return? no.38.If yes, please specify what other defect(s) were observed.1.The target location - where is the "hile" area? biliary tree.2.What size wire guide was used - 0.25inch, 0.035inch? 035.3.How were the procedures completed? with another zilver 635.

Manufacturer Narrative

Pma/510(k) # k163018.Investigation is still pending, a follow-up mdr report will be submitted to include the investigation conclusions.

Manufacturer Narrative

Pma/510(k) # k163018.Investigation is still pending, a follow-up mdr report will be submitted to include the investigation conclusions.

Event Description

This supplemental report is being submitted due completion of the lab evaluation on 13-apr-2023.

Manufacturer Narrative

Pma 510k #k163018 device evaluation the zilbs-635-10-12 device of lot number c1927441 involved in this complaint was returned for evaluation, with the original packaging.The packaging was open on receipt.With the information provided, a physical examination and document-based investigation was conducted.The device related to this occurrence underwent a laboratory evaluation.On evaluation of the device the following was noted: visual inspection: red safety tab not returned.Flushing syringe still attached.Curvature observed at end of catheter.Separation of outer sheath approximately 35cm from distal tip.Functional inspection: device flushed with no issue.0.035" wire guide passed with no issue.This is the required guide wire size for this device as per instructions for use.Unable to deploy stent.Manufacturing records prior to distribution all devices are subjected to a visual inspection and functional inspection to ensure device integrity a review of the manufacturing records did not reveal any discrepancies that could have contributed to this complaint issue.Review historical data the review of relevant manufacturing records confirms the failure mode has not previously occurred for this work order.Instructions for use/label there is no evidence to suggest that the customer did not follow the instructions for use (ifu0065).Image review an image was not returned for evaluation root cause review a definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.A possible root cause could be attributed to the patient`s anatomy compressing the flexor making stent release difficult.It is known that the target location was the hile biliary tree and that the patients anatomy was tortuous.Although it is stated that the physician did not experience any resistance while advancing the device it is possible that the tortuous anatomy could have caused the angle/ position of the device in the hile biliary tree to exert pressure on the flexor which could have resulted in the separation of the outer sheath and thus the inability of the stent to be deployed.Confirmation of complaint the complaint is confirmed based on visual and functional inspection.Summary according to the initial reporter, the prostheses did not drop, the installation system broke."as per cc form": when the doctor wanted to deploy the stent, the delivery system broke.Confirmed quantity of 1 device, confirmed used.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The procedure was completed with another zilbs device.Investigation findings conclude definitive root cause could not be determined.A possible root cause could be attributed to the patient`s anatomy compressing the flexor making stent release difficult.Complaint is confirmed based on visual and functional inspection.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

This supplemental report is being submitted due completion of the investigation on 24-may-2023.

• Brand Name: ZILVER 635 BILIARY SELF EXPANDING METAL STENT
• Type of Device: FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 16662758
• MDR Text Key: 312984113
• Report Number: 3001845648-2023-00207
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 10827002238166
• UDI-Public: (01)10827002238166(17)250330(10)C1927441
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/24/2023

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 Model Number: G23816
• Device Catalogue Number: ZILBS-635-10-12
• Device Lot Number: C1927441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/23/2023
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/07/2023
• Initial Date FDA Received: 04/03/2023
• Supplement Dates Manufacturer Received: 03/07/2023; 03/07/2023
• Supplement Dates FDA Received: 05/11/2023; 06/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2022
• 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