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 Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Obstruction/Occlusion (2422)

Event Date 06/21/2023

Event Type  Injury  

Event Description

(b)(6) 2023 - utility of bilateral intraductal plastic stent for malignant hilar biliary obstruction compared with bilateral self-expandable metal stent: a propensity score¿matched cohort analysis.Bilateral transpapillary stent placement was performed using a standard duodenoscope (tjf-200, jf-240, jf-260v, or tjf-260v; olympus medical systems, tokyo, japan).After cholangiography, a guidewire (.025-inch visiglide2 [olympus medical system system],.025-inch endoselector [boston scientific japan, tokyo, japan]; or.025-inch m-throughtm [asahi intecc, aichi, japan]) was inserted into the intrahepatic bile duct (ihbd).Patients underwent endoscopic sphincterotomy (es) after placing the guidewire on the opposite side of the ihbd, if necessary.Bilateral sems placement was performed by 1 of 2 methods, the ¿stent-in-stent¿ (sis) and ¿side-by-side¿ (sbs) techniques.In the sis placementmethod, the first uncovered sems was deployed across the confluence on 1 side of the ihbd.The guidewire was accessed on the opposite side of the ihbd through the first sems mesh, and the second uncovered sems was deployed through the first sems (fig.1b).Because this was a retrospective study, the various types of sems used for sis placement were as follows: niti-s large cell d-type biliary stent (teawoong, seoul, korea), bonastent m-hilar (standard sci-tech, seoul, korea), hilzo stent (bcm co, ltd, gyeonggi-do, south korea), bilerush (piolax medical devices, yokohama, japan), zilver 635 stent (cook medical, bloomington, ind, usa), zeo stent (zeon medical inc, tokyo, japan), and jostent selfx stent (abbott- vascular devices, temecula, calif, usa).For sbs placement, the 2 uncovered sems delivery catheters were inserted into the bilateral ihbds, and both semss were placed (fig.1c).The sems types used for sbs placement were bilerush, zilver 635 stent, and hanarostent (mi tech, seoul, korea).The semss were divided into braided (niti-s, nonastent, hilzo, andhanarostent) and laser-cut (bilerush, zilver, zeo, and jostent) types.All sems diameters were 8 or 10mm.The lengths of the iss and semsswere determined by the main operators, considering the malignant biliary obstruction (mbo) length and distal common bile duct.5 cases of cholecystitis cases were successfully managed with percutaneous drainage.Temporary enbd placement: was performed in in 12 cases (63%) in the sems group.Patient outcome: require intervention/additional procedures s=4.

Manufacturer Narrative

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

• 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: 19069581
• MDR Text Key: 339679785
• Report Number: 3001845648-2024-00153
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2024
• 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: 06/21/2023
• Event Location: Hospital
• Date Manufacturer Received: 03/11/2024
• 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: 76 YR
• Patient Sex: Male