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

Model Number	M00570370
Medical Device Problem Codes	Difficult to Remove (1528); Device Stenosis (4066)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.Block h6: imdrf device code a150207 captures the reportable event of stent difficult to remove.Imdrf device code a0106 captures the reportable event of stent obstruction within device.Imdrf impact code f2301 captures the additional stent placed stent-in-stent to allow necrosis and remove the stent.Imdrf impact code f23 captures the argon plasma coagulation (apc) done to remove the tissue ingrowth.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary fully covered rmv stent was implanted in the common bile duct to treat a benign stricture during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed six months prior.The patient's anatomy was not tortuous and was not dilated prior to stent placement.Post stent placement, on an unknown date, the stent was attempted to be removed using snare, rat-tooth forceps, and extraction balloon; however, the stent was unable to be removed due to tissue ingrowth on the retrieval loop.Consequently, a 10x80 wallflex biliary stent was placed inside the original stent to allow pressure necrosis and loosen the tissue ingrowth.On july 29, 2024, the patient returned for another stent removal procedure.The stent was attempted to be removed using snare and rat-tooth forceps, but the stent was still unable to be removed.Subsequently, argon plasma coagulation (apc) was done to remove the tissue.Eventually, the stent was able to be removed, 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; 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: 20031833
• Report Number: 3005099803-2024-04037
• Device Sequence Number: 14202693
• Product Code: PNB
• UDI-Device Identifier: 08714729953180
• UDI-Public: 08714729953180
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: DEN150040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/21/2024

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 Model Number: M00570370
• Device Catalogue Number: 56424
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2024
• Initial Report FDA Received Date: 08/22/2024
• 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