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

Model Number	M00570360
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Use of Device Problem (1670); Human-Device Interface Problem (2949); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the manufacture and expiration dates are unknown.(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on may 05, 2021 that a wallflex biliary rx fully covered biliary rmv stent was implanted in the bile duct to treat biliary stones/ stricture during a procedure performed on an unknown date.Reportedly, the patient's anatomy was not dilated prior to stent placement.On (b)(6) 2021, during a scheduled endoscopic retrograde cholangiopancreatography (ercp) with stent removal procedure, the stent was attempted to be removed.Upon removal of the stent, it was noted that the stent was covered in hyperplastic tissue.During removal, the stent became unraveled and broke apart.Eventually, the broken pieces were successfully remove from the patient using rat tooth forceps and the procedure was completed.There were no patient complications reported as a result of this event.Note: it was reported that the wallflex biliary rx fully covered rmv stent was implanted to treat biliary stones.However, per the wallflex biliary rx fully covered stent system rmv, the stent is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplams, relief of malignant biliary obstruction prior to surgery and for indwell up to 12 months in the treatment of benign biliary strictures secondary to chronic pancreatitis.The wallflex biliary stent is not indicated to be treat biliary stones.

• Brand Name: WALLFLEX BILIARY
• Common Device Name: BILIARY STENT SYSTEM FOR BENIGN STRICTURES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11872496
• Report Number: 3005099803-2021-02432
• Device Sequence Number: 921997
• Product Code: PNB
• UDI-Device Identifier: 08714729953173
• UDI-Public: 08714729953173
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: DEN150040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted 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): 05/24/2021

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 Model Number: M00570360
• Device Catalogue Number: 7036
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/05/2021
• Initial Report FDA Received Date: 05/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1