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

Model Number	M00570380
Medical Device Problem Codes	Difficult to Remove (1528); Use of Device Problem (1670); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2023, that a wallflex biliary rx fully covered rmv stent was to be implanted in the bile duct to treat stones during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.The patient's anatomy was tight.During the procedure, the stent was successfully implanted; however, during removal, the delivery system got caught in the stent and the inner sheath snapped off of the delivery system.The stent and the inner sheath were removed using forceps and the procedure was completed using another wallflex biliary stent.There were no patient complications reported as a result of this event.Note: it was reported that the stent was attempted to be implanted to treat stones.However, per the wallflex biliary rx fully covered stent system rmv directions for use, the stent is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms, 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 device is not indicated to be placed to treat stones.
Additional Manufacturer Narrative
Imdrf device code a0501 captures the reportable event of inner sheath detached.Imdrf device code a150207 captures the reportable event of delivery system difficult to remove.

• 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
• 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: 16640041
• Report Number: 3005099803-2023-01675
• Device Sequence Number: 20357728
• Product Code: PNB
• UDI-Device Identifier: 08714729953197
• UDI-Public: 08714729953197
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: DEN150040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/29/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/20/2024
• Device Model Number: M00570380
• Device Catalogue Number: 56424
• Device Lot Number: 0030573274
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2023
• Initial Report FDA Received Date: 03/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown