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); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a150207 captures the reportable event of the delivery system difficult to remove.Imdrf device code a1502 captures the reportable event of the stent positioning issue.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary rx fully covered rmv stent was to be implanted in the common bile duct to treat a malignant 5 cm stricture during an endoscopic retrograde cholangiopancreatography (ercp) performed on (b)(6) 2023.The patient's anatomy was tortuous and was not dilated prior to stent placement.During the procedure, the stent was successfully deployed into the anatomy.Upon removal, difficulty was experienced in recapturing the delivery system when the tip became stuck to the proximal end of the stent, causing the stent to move distally and protrude out into the duodenum.Only 3-4 diamonds were visible above the stricture, and about 3 1/2 cm were protruding out into the duodenum.The stent was removed from the patient using forceps, and a different stent was used to complete the procedure.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: 18377810
• Report Number: 3005099803-2023-06830
• Device Sequence Number: 7580204
• Product Code: PNB
• UDI-Device Identifier: 08714729953197
• UDI-Public: 08714729953197
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 12/21/2023

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: 05/30/2024
• Device Model Number: M00570380
• Device Catalogue Number: 7038
• Device Lot Number: 0029502034
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2022
• 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