MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX BILIARY RX STENT SYSTEM; CATHETER, BILIARY, DIAGNOSTIC

Model Number M00576820

Device Problems Activation, Positioning or Separation Problem (2906); Material Deformation (2976); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/18/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A wallflex biliary rx covered rmv stent and delivery system were received for analysis.Visual examination found the stent was returned partially deployed.The outer blue sheath was kinked approximately 50 cm from the tip of the delivery system.The outer sheath stretched out in the guidewire access sleeve (gas) section and the gas ramp was lifted.The inner shaft was kinking out of gas.The stent was inspected and the stent cover was found damaged (holes).Functional evaluation revealed that it was not possible to deploy the stent using the delivery system as received; however, the stent was deployed by manually gripping the outer sheath and pulling the tip distally.No other issues were noted to the stent and delivery system.The reported events of stent partially deployed, inner sheath kinking out of gas, and sheath kinked were confirmed.The investigation concluded that the reported events and observed failure of stent cover damage were likely due to anatomical factors encountered during the procedure.Tortuous anatomy and difficult cannulation could have increased the resistance during advancing of the device through the patient and as a result, the user may have applied more force to the device during use contributing to the reported and observed failures.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to patient condition.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

Event Description

It was reported to boston scientific corporation that a wallflex biliary rx covered rmv stent was to be implanted to treat a 4cm cholangiocarcinoma in the common bile duct during an endoscopic retrograde cholangiopancreatograhy (ercp) with metal stenting procedure performed on (b)(6) 2021.Reportedly, the patient's anatomy was very tortuous and was difficult for cannulation.During the procedure, the inner sheath kinked out of the guidewire access sheath section and the stent was partially deployed.The stent was removed from the patient and noticed that the outer sheath kinked at the yellow transition zone.The procedure was completed with another wallflex biliary stent.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Note: this event has been deemed an mdr reportable event based on investigation result which revealed the stent cover was damaged (holes).

• Brand Name: WALLFLEX BILIARY RX STENT SYSTEM
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 11508463
• MDR Text Key: 240668517
• Report Number: 3005099803-2021-01092
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2022
• Device Model Number: M00576820
• Device Catalogue Number: 7682
• Device Lot Number: 0025931391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2020
• 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 Age: 72 YR