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

Model Number	G50624
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) # k163018.The investigation is in progress and a follow up mdr will be submitted.
Event or Problem Description
Distal cbd stricture after cannulation mild sphincterotomy and dilation the cbd with 9frsbdc, zilbs-635-10-8 tried to deployed stent gone inside but feel resistance while deployed without given more pressure taken out the stent, seen 2-3 gages of the stent never opened.Finished the case by deploying another zilver biliary metal stent - zilbs-635-10-8.
Event or Problem Description
Supplemental report is being submitted due to the completion of a lab evaluation on 15-mar-2022: visual inspection: red safety lock not returned.Stent is partially deployed on return and exposed part of the stent appears to be damaged.No kinks or damage to the outer sheath.
Additional Manufacturer Narrative
Pma/510(k) # k163018.The investigation is in progress and a follow up mdr will be submitted.
Event or Problem Description
Supplemental report is being submitted due to the completion of the investigation.
Additional Manufacturer Narrative
Pma/510(k) # k163018.Device evaluation: the zilbs-635-10-8 device of lot number c1857198 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.Lab evaluation: the device related to this occurrence underwent a laboratory evaluation on the 15th march 2022.In summary the following results were observed in the lab evaluation: visual inspection: red safety lock not returned.Stent is partially deployed on return and exposed part of the stent appears to be damaged.No kinks or damage to the outer sheath.Functional inspection:0.035 inch wire guide passed with no issues; device flushed with no issue; stent deployed with no issue.Documents review including ifu review: prior to distribution zilbs-635-10-8 devices are subjected to a visual inspection and functional checks to ensure device integrity.A review of the manufacturing records for zilbs-635-10-8 of lot number c1857198 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 c1857198.The instructions for use (ifu0065) instructs the user to inspect the device on removal from the packaging:¿ upon removal from the package, inspect the product to ensure no damage has occurred.¿ there is no evidence to suggest the user did not follow the ifu.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 tortuous anatomy which may have compressed or rotated the delivery system as it advanced and prevented the stent from being deployed.Stent was partially deployed on return and exposed part of the stent appeared to be damaged, likely build up pressure.It may be noted that returned device functioned as intended.As per additional information provided; "said he tried to deploy the stent after dilation and sphincterotomy, stent is gone inside the cbd over the wire with resistance , endoscopy nurse tried to deploy the stent once the stent cross the targeted position , not able to deploy the stent , seen resistance while deploying , so taken out the stent without giving more pressure to the stent ,noticed that first few cells ( stent body ) is opened.Stent is partially opened while taking out from the patient , finished case by deployed another zilver" summary.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.According to the initial reporter, a plastic stent was placed to complete the procedure.No adverse effects to the patient were reported.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: ZILVER 635 BILIARY SELF EXPANDING METAL STENT
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer (Section G): COOK IRELAND; holstein campus kiel; arnold- keller str- 3; limerick
• Manufacturer Contact: sinead o'leary ; holstein campus kiel; arnold- keller str- 3; limerick
• MDR Report Key: 13266322
• Report Number: 3001845648-2022-00021
• Device Sequence Number: 16521065
• Product Code: FGE
• UDI-Device Identifier: 10827002506241
• UDI-Public: (01)10827002506241(17)240811(10)C1857198
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/07/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/11/2024
• Device Model Number: G50624
• Device Catalogue Number: ZILBS-635-10-8
• Device Lot Number: C1857198
• 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: 12/21/2021
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/22/2021
• Supplement Date Received by Manufacturer: 12/22/2021; 12/22/2021
• Initial Report FDA Received Date: 01/17/2022
• Supplement Report FDA Received Date: 04/13/2022; 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Male