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

Catalog Number UNKNOWN

Device Problems Partial Blockage (1065); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Obstruction/Occlusion (2422)

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) #: k182980.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Huang ¿ ¿comparison of uncovered stent placement across versus above the main duodenal papilla for malignant biliary obstruction¿.The overall length of the obstruction and the distance from the end of obstruction to the papilla were confirmed.The guide wire was exchanged for a 0.035-inch guide wire (amplatz super stiff; boston scientific, natick, massachusetts), and a self-expanding metal stent was inserted through the wire.Stents were placed across the papilla in patients with tumor obstruction the lower 2 cm of the cbd, and above the papilla in patients without peripapillary obstruction.The stent protruded 1 cm into the duodenum if it was inserted across the papilla.Postdilution of the stent was not necessary.An 8.5-f external biliary drainage catheter (cook) was left above the stent if necessary.The drainage catheters were irrigated after the operation.

Manufacturer Narrative

Device evaluation the zib device of unknown lot number involved in this complaint was implanted in the patient and was not available for evaluation.Document review: prior to distribution zib 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 the zib device could not be performed as the lot number is unknown.There is no evidence to suggest the user did not follow the instructions for use (ifu0040-6).Root cause review: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to patient pre-existing conditions.From the information provided it is known that the patient had a history of malignancy.Summary: the complaint is confirmed based on customer testimony.According to the initial reporter, in group 1, 18 patients developed recurrent biliary obstruction during the postprocedural survival time.Among these, eight were treated with a second stent insertion, six had external bile drainage, and the other four were not treated because of poor general condition.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental report is being submitted due to the completion of the investigation.

• Brand Name: ZILVER 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; o'halloran road; national technology park; limerick
• Manufacturer Contact: aisling hassett ; o'halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 9930679
• MDR Text Key: 196739041
• Report Number: 3001845648-2020-00212
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• PMA/PMN Number: K900923
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/19/2020
• Initial Date FDA Received: 04/06/2020
• Supplement Dates Manufacturer Received: 03/19/2020
• Supplement Dates FDA Received: 02/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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