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

Model Number	M00570370
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary rx fully covered rmv stent was implanted to treat a bile duct stricture during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on an unknown date on (b)(6) 2024, during a stent removal procedure performed around 6 months later from the initial implant, the stent was attempted to be removed using a snare by pulling the stent out of the duct; however, after several attempts, the stent was unable to be removed.The physician then reinserted the duodenoscope into the duodenum and it was found that the stent broke in the middle.The snare was removed, and a rat tooth forceps was used to remove the stent by grabbing the proximal sections of stent above the middle where it was fractured.The stent was eventually able to be removed.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number.Therefore, the manufacture and expiration dates are unknown.Block h6: imdrf device code a0401 captures the reportable event of stent break imdrf device code a150207 captures the reportable event of stent difficult to remove.
Additional Manufacturer Narrative
Block b5 has been updated with the additional information received on october 18, 2024.Block d4, h4: the complainant was unable to provide the suspect device lot number.Therefore, the manufacture and expiration dates are unknown.Block h6: imdrf device code a0401 captures the reportable event of stent break.Imdrf device code a150207 captures the reportable event of stent difficult to remove.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary rx fully covered rmv stent was implanted to treat a bile duct stricture during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on an unknown date on (b)(6), 2024, during a stent removal procedure performed around 6 months later from the initial implant, the stent was attempted to be removed using a snare by pulling the stent out of the duct; however, after several attempts, the stent was unable to be removed.The physician then reinserted the duodenoscope into the duodenum and it was found that the stent broke in the middle.The snare was removed, and a rat tooth forceps was used to remove the stent by grabbing the proximal sections of stent above the middle where it was fractured.The stent was eventually able to be removed.There were no patient complications as a result of this event.Additional information received on october 18, 2024.According to the physician, the stricture was benign with an unknown etiology.The patient's anatomy was not dilated during the stent placement.The procedure performed on (b)(6) 2024, was a planned stent removal.

• 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: 20440847
• Report Number: 3005099803-2024-05075
• Device Sequence Number: 8330620
• Product Code: PNB
• UDI-Device Identifier: 08714729953180
• UDI-Public: 08714729953180
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,Followup
• Report Date (Section B): 11/12/2024

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: 7037
• 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: 09/19/2024
• Supplement Date Received by Manufacturer: 10/18/2024
• Initial Report FDA Received Date: 10/14/2024
• Supplement Report FDA Received Date: 11/12/2024
• 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