MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER 635 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 Date 01/04/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Kanno et al 2020 (zilbs) ¿ ¿inside plastic stents versus metal stents for treating unresectable malignant perihilar biliary obstructions: a retrospective comparative study¿.Multiple mss were placed using a partial stent-in-stent (off label use) or side-by-side (off label use in (b)(6)) method at the endoscopist¿s discretion.When three or more stents were required, the psis method was applied (three or more stents were not placed using the sbs method or using a hybrid of the two methods).When it was difficult to place the stent(s) through the previously deployed stent, multiple endoscopy sessions were permitted.Recurrent biliary obstruction: rbo was observed in (33/77) of patients.Re-intervention for rbo was performed for 28 (36%) patients in the ms group with the use of endoscopic ultrasonography-guided hepaticogastrostomy in 5 ms-group patients and percutaneous biliary drainage in 1 ms-group patient.Three or more re-interventions were required for 10 patients (11%) in the ms group, although the overall survival was similar.

Event Description

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

Manufacturer Narrative

Pma/510(k)#: k163018.Device evaluation: the zilver 635 biliary self expanding metal stents of unknown lot numbers involved in this complaint was implanted in the patients and were not available for evaluation.With the information provided, a document-based investigation was conducted.Document review: as the lot numbers of these complaint stents are unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution all zilver 635 biliary self expanding metal stent devices are subject 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.There is no evidence to suggest the user did not follow the instructions for use (ifu0065-3) the japanese packaging insert c-es1207m06 supplied with the device complies with mhlw law no.84 of 2013 which avoids including information that is not specific to the medical device or that which is basic knowledge already understood by the healthcare professional, to ensure to accurately convey all the information that is important for the user.Root cause review: a definitive root cause could not be determined from the available information.Patients pre-existing conditions were likely a contributing factory to the recurrent biliary obstruction.Stent occlusion (which is an obstruction/blockage) is listed as a potential known adverse event in the instructions for use.Summary: the complaint is confirmed based on customer testimony.All patients required an additional intervention complaints of this nature will continue to be monitored for potential emerging trends.

• 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: aisling hassett ; o halloran road; national technology park; limerick
• MDR Report Key: 10362441
• MDR Text Key: 209559341
• Report Number: 3001845648-2020-00471
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/05/2021

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/04/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/28/2020
• Initial Date FDA Received: 08/04/2020
• Supplement Dates Manufacturer Received: 07/28/2020
• Supplement Dates FDA Received: 12/03/2021
• 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
• Patient Age: 79 YR
• Patient Sex: Male