MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX BILIARY; BILIARY STENT SYSTEM FOR BENIGN STRICTURES

Model Number	M00570360
Medical Device Problem Codes	Difficult to Remove (1528); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A wallflex biliary rx delivery system was received for analysis; the stent was not returned.Visual examination of the returned device found the yellow jacket was damaged in the proximal section.The inner sheath and the outer light blue sheath were kinked.The outer sheath was stretched out in the guidewire access sleeve (gas) section.The outer clear sheath was kinked in several section.No other issues with the device were noted.The reported event of delivery system difficult to remove and device difficult to remove were not confirmed.It is not possible to replicate functional failures in the laboratory of analysis.The reported event of sheath kinked was confirmed; the outer sheath was returned kinked.The investigation concluded that the reported events and the observed failures were most likely due to the factors encountered during the procedure.It may be that the technique used by the user and the interaction of the device with the scope during removal of the delivery system contributed to the resistance felt during the procedure.The amount of force applied could have caused the kinks noted in the inner and outer sheath, as well as, the damage to the yellow jacket.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to the procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and from the information available, this device was used per the instructions for use (ifu)/ product label.
Event or Problem Description
It was reported to boston scientific corporation on march 01, 2021 that a wallflex biliary rx fully covered rmv stent has been implanted in the common bile duct (cbd) to treat a malignant stricture during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.Reportedly, the patient's anatomy was not tortuous and was not dilated prior to stent placement.During the procedure, the stent was deployed successfully inside the patient.However, during catheter removal, the delivery system was difficult to remove through the deployed stent and from the scope.The physician attempted to re-sheath the stent several times and attempted several different scope positions; eventually the delivery system was removed from the patient.After the delivery system was removed it was noted that the delivery system was bent.The stent remains implanted and the procedure was completed.There were no patient complications reported as a result of this event.

• Brand Name: WALLFLEX BILIARY
• Common Device Name: BILIARY STENT SYSTEM FOR BENIGN STRICTURES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 3 00 boston scientific way; marlborough MA 01752
• MDR Report Key: 11567951
• Report Number: 3005099803-2021-01208
• Device Sequence Number: 4150800
• Product Code: PNB
• UDI-Device Identifier: 08714729953173
• UDI-Public: 08714729953173
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: DEN150040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/25/2021

1 Device was Involved in the Event

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: 12/09/2022
• Device Model Number: M00570360
• Device Catalogue Number: 7036
• Device Lot Number: 0026487697
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 03/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1