MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER 518 BILIARY SELF-EXPANDING STENT; FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL

Model Number	G36048
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) #p050017/s002 and s003.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
When pinned and pulled, the stent flowered out, but the last 1 cm of the stent would not exit out.The device was completely pulled back to the hub.The stent should have completely deployed at this point.The user pulled the whole deployment system back to deploy stent in target site.This occurred with every stent used in this case: (b)(4) ¿ g43773, lot number c1753166, (b)(4) ¿ g43773, lot number c1794186, (b)(4) ¿ g43773, lot number c1633402, (b)(4) ¿ g36048, lot number c1778086, (b)(4) ¿ g36048, lot number c1810418.Did any unintended section of the device remain inside the patient¿s body? no.Was the patient hospitalized or was there prolonged hospitalization? no.Did the patient require any additional procedures due to this occurrence? no.Did the product cause or contribute to the need for additional procedures? no.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? na.At what stage of the procedure did the complaint occur? stent placement details of access sheath used (name, fr size, length)? 5 fr terumo slender sheath did the patient require any additional procedures as a result of this event? no.What intervention (if any) was required? none as per answers to additional questions on 17-jun-2022 1.Are images of the device or procedure available? n/a, yes, no: no.2.What was the target location for the stent?- sfa.3.Was the device used percutaneously? n/a, yes, no: yes.4.Was the product inspected for kinks or damage before use? n/a, yes, no: yes.5.Was the device flushed through both flushing port before the procedure, as per ifu? n/a, yes, no.6.Was pre-dilation performed ahead of placement of the stent? n/a, yes, no: yes.7.Was post-dilation performed after the placement of the stent? n/a, yes, no: yes.8.Details of the wire guide used (name, diameter, hydrophilic)?- info not available.9.Did the patient exhibit difficult or altered anatomy (if altered please specify how it is altered)? n/a, tortuous, calcified, altered- calcified.10.Was resistance encountered when advancing the wire guide to the target location? n/a, yes, no: yes.11.Was resistance encountered when advancing the delivery system to the target location? n/a, yes, no: no.12.How did the physician deal with this resistance? n/a.13.Was the approach ipsilateral or contralateral? n/a, ipsilateral, contralateral- contralateral.¿ if contralateral, was the bifurcation angle steep? n/a, yes, no: no.14.Did the tip of the delivery system cross the target location? n/a, yes, no: yes.15.Was the delivery system tracked around a tight angle in the patient anatomy? n/a, yes, no: no.16.Was the delivery system damaged/kinked/twisted during deployment? n/a, yes, no: no.17.Was the handle pulled towards the hub during deployment? n/a, yes, no- not sure.18.Was the delivery system pushed during deployment? n/a, yes, no: not sure.19.Was the stent deployed smoothly / without resistance? n/a, yes, no: no.¿ if no, please detail any difficulty experienced during deployment: the doctor pin and pulled the delivery system until it was hubbed, but the stent wouldn¿t come off the delivery system.The doctor had to ¿shake¿ the deliver system to get the stent to come off.20.What artery was the stent placed in? sfa.21.Was the stent fully deployed from the delivery system prior to removal of the delivery system? n/a, yes, no: yes.22.Did the patient have any pre-existing conditions? n/a, yes, no: no.23.Were any other defects (other than the complaint issue) observed on the delivery system prior to return (e.G.Kink)? n/a, yes, no: no.Off label use confirmed on 17-jun-2022 for intended placement in sfa.
Additional Manufacturer Narrative
Pma/510(k) # k182980.Device evaluation: the zib5-125-5.0-80 device of lot number c1810418 involved in this complaint was returned for evaluation, without the original packaging.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 30th may 2022.Refer to (b)(4) attendance for lab attendance and the returned product-notes field for lab evaluation notes.On evaluation of the device, it was noted during the visual inspection that the red safety lock was not returned, and the outer sheath was separated from the handle.Upon functional inspection, a 0.018inch wire guide passed with no issue, the device flushed with no issue and the delivery system was manually deployed.The stent was not returned.Document review: prior to distribution zib5-125-5.0-80devices are subjected to a visual inspection and functional checks to ensure device integrity.A review of the manufacturing records for zib5-125-5.0-80 of lot number c1810418 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 c1810418.It should be noted that the instructions for use (ifu0042-9) states the following: ¿the zilver 518 and 635 biliary stents are intended for palliation of malignant neoplasms in the biliary tree¿.There is evidence to suggest the user did not follow the ifu.From the additional questions answered, it was ascertained that the physician placed the stent into the sfa for which it is not intended.Root cause review: a definitive root cause of off label use was determined from the available information.The ifu0042 states that the device is intended for use in the biliary tree but from the information given, it was revealed that the physician had used the device in the sfa artery.Summary: the complaint is confirmed based on customer testimony.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 or Problem Description
Supplemental report is being submitted due to a correction to the rpn on 30-aug-2022 and subsequent completed investigation on 16-sept-2022.Rpn changed from ziv5-18-125-6-80 to zib5-125-5.0-80.

• Brand Name: ZILVER 518 BILIARY SELF-EXPANDING 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: 15257670
• Report Number: 3001845648-2022-00551
• Device Sequence Number: 1856329
• Product Code: FGE
• UDI-Device Identifier: 10827002360485
• UDI-Public: (01)10827002360485(17)240318(10)C1810418
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2022
• 2 Devices were Involved in the Event: 1 2

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: 03/18/2024
• Device Model Number: G36048
• Device Catalogue Number: ZIB5-125-5.0-80
• Device Lot Number: C1810418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/15/2022
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/15/2022
• Supplement Date Received by Manufacturer: 03/15/2022
• Initial Report FDA Received Date: 08/19/2022
• Supplement Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2021
• 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 Sex: Unknown