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

Model Number G23812

Device Problems Break (1069); Activation, Positioning or Separation Problem (2906); Insufficient Information (3190)

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

Event Date 02/15/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

As reported to customer relations via phone conversation "went to deploy the stent, it would not deploy.A new g23812-zilbs-635-6-12 was opened and used to complete the procedure successfully." did any unintended section of the device remain inside the patient¿s body? - no.Please describe the object and how it was retrieved: did the patient experience a delay or require any additional procedure due to this occurrence? - no.Please specify delay or any additional procedure(s) and provide details: has the complainant reported any adverse effects on the patient due to this occurrence? - no.Has the complainant reported that the product caused or contributed to the adverse effects? - no.Please specify adverse effects and provide details.3.2.13 are images of the device or procedure available? n/a.3.2.14 at what stage of the procedure did the complaint occur? unpacking or preparation, insertion, during stent placement, removing the introducer post stent placement? - during stent placement.3.2.15 was a sphincterotomy performed prior to use of the stent device? - yes.3.2.16 was balloon dilation performed prior to use of the stent device? - no.3.2.17 what was the length and diameter of the stricture? - approx 4 cm's.3.2.18 what brand of endoscope was used with the device? - olympus.3.2.19 was the product inspected for kinks or damage before use? - no.3.2.20 what was the position of the elevator during deployment? - asku.3.2.21 was the delivery system tracked around a tight angle in the patient anatomy or around a tight angle in an endoscope? - no.3.2.22 was the device flushed through both flushing ports before the procedure, as per ifu? - yes.3.2.23 details of the wire guide used (name, diameter, hydrophilic)? - acrobat 2.035 450 3.2.24 what was the target location for the stent? - common hepatic duct 3.2.25 was the red safety lock removed before inserting the delivery system? - no 3.2.26 was the red safety lock removed before stent deployment? - yes 3.2.27 was the patient's anatomy tortuous? - asku.3.2.28 did the patient exhibit altered anatomy? - n/a.If yes, please specify the type of altered anatomy: 3.2.29 did the patient have any pre-existing conditions? - asku.If yes, please state the specific condition(s): 3.2.30 was resistance encountered when advancing the wire guide to the target location? - no.If yes, how did the physician deal with this resistance? - n/a.3.2.31 was resistance encountered when advancing the delivery system to the target location? - no.If yes, how did the physician deal with this resistance? - n/a 3.2.32 was there resistance felt passing the delivery system through the stricture? - no.3.2.33 was any damage noted on the wire guide before, during or after the procedure? - no.3.2.34 did the tip of the delivery system cross the target location? - yes.3.2.35 was the handle pulled toward the hub during deployment? - yes.3.2.36 was the delivery system pushed during deployment? - no.3.2.37 was the stent being placed through the side wall of a previously placed stent? - no.3.2.38 was the stent deployed smoothly / without resistance? - it did not deploy 3.2.39 was the stent fully deployed before removing the delivery system from the patient? - it was never deployed.3.2.40 did any part of the product snag/get caught on the stent when removing the delivery system? - the stent was neve deployed.3.2.41 was post-dilation performed after the placement of the stent? - stent dever deployed.3.2.42 did the patient require any additional procedures as a result of this event? - no.If yes, what intervention was required? - n/a.3.2.43 was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? - took the defective stent out and placed a new as described above.3.2.44 were any other defects (other than the complaint issue) observed on the delivery system prior to return? - there is it appears the catheter stripped / broke.If yes, please specify what other defect(s) were observed: - n/a.

Manufacturer Narrative

Pma/510(k) #k163018.The zilbs-635-6-12 device of lot number c1760624 involved in this complaint was returned for evaluation, with the box but without the pouch.With the information provided, a physical examination and document-based investigation was conducted.The device related to this occurrence underwent a laboratory evaluation on the 15 march 2022.On evaluation of the device the red safety lock was not returned, and the outer sheath was separated approx.28cm from the white tip.The 0.035-inch wire guide passed with no issues, the device flushed with no issues and the stent could not be deployed.Prior to distribution zilbs-635-6-12 devices are subjected to a visual inspection and functional checks to ensure device integrity.A review of the manufacturing records for zilbs-635-6-12 of lot number did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records confirms the failure mode has not previously occurred with the current lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1760624.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 pre-existing conditions.It is stated that the patient had common bile duct (cbd) stricture.If the device was bent around a tight angle in the patient¿s anatomy during attempted deployment it may have contributed to this occurrence, as resistance during advancement can increase the deployment forces resulting in the separation of the outer sheath hence preventing the user from deploying the stent.Complaint is confirmed as the failure was verified in the laboratory.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental report is being submitted due to a lab evaluation complete on 15-mar-2022 and the investigation was completed on the 24-mar-2022 visual inspection: red safety lock not returned.Separation of the outer sheath from the white tip approx, 28cm.Functional inspection: 0.035 inch wire guide passed with no issues.Device flushed with no issues.Unable to deploy the stent.

Manufacturer Narrative

Pma/510(k) #k163018.Device evaluation the zilbs-635-6-12 device of lot number c1760624 involved in this complaint was returned for evaluation, with the box but without the pouch.With the information provided, a physical examination and document-based investigation was conducted.Lab evaluation the device related to this occurrence underwent a laboratory evaluation on the 15 march 2022.On evaluation of the device the red safety lock was not returned, and the outer sheath was separated approx.28cm from the white tip.The 0.035-inch wire guide passed with no issues, the device flushed with no issues and the stent could not be deployed document review prior to distribution zilbs-635-6-12 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 cirl.A review of the manufacturing records for zilbs-635-6-12 of lot number did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records confirms the failure mode has not previously occurred with the current lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1760624.Image review: n/a.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 pre-existing conditions.It is stated that the patient had common bile duct (cbd) stricture.If the device was bent around a tight angle in the patient¿s anatomy during attempted deployment it may have contributed to this occurrence, as resistance during advancement can increase the deployment forces resulting in the separation of the outer sheath hence preventing the user from deploying the stent.Summary: complaint is confirmed as the failure was verified in the laboratory.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

A supplemental correction report is being submitted to an update to the investigation (a code) and the investigation conclusions on the 04-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: 13788590
• MDR Text Key: 297314142
• Report Number: 3001845648-2022-00155
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 10827002238128
• UDI-Public: (01)10827002238128(17)230921(10)C1760624
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/21/2023
• Device Model Number: G23812
• Device Catalogue Number: ZILBS-635-6-12
• Device Lot Number: C1760624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/15/2022
• Event Location: Hospital
• Date Manufacturer Received: 02/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2020
• 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 Sex: Male