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	08/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medwatch report# mw5103120.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2021-04831 for the associated device information.It was reported to boston scientific corporation on august 26, 2021 that a 10x60 wallflex biliary fully covered stent was to be implanted to treat an approximately 5cm stricture in the middle and distal common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with sphincterotomy and stent placement procedure performed on (b)(6) 2021.Reportedly, the patient's anatomy was dilated prior to stent placement procedure.During the procedure, a 10x60 wallflex biliary fully covered stent (the subject of mfr.Report # 3005099803-2021-04831) was fully deployed; however, when the delivery system was removed, the stent adhered to the delivery system and moved out its correct location.Consequently, the stent was removed and a 10x80 wallflex biliary stent (the subject of this report) was attempted to be implanted.Again, after the stent was fully deployed, when the delivery system was removed, the stent adhered to the delivery system and moved out its correct location.The stent was also removed and the procedure was completed with another wallflex biliary stent.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
• MDR Report Key: 12484869
• Report Number: 3005099803-2021-04833
• Device Sequence Number: 3936503
• Product Code: PNB
• UDI-Device Identifier: 08714729953197
• UDI-Public: 08714729953197
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/16/2021

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: 02/22/2023
• Device Model Number: M00570380
• Device Catalogue Number: 7038
• Device Lot Number: 0026849424
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/26/2021
• Initial Report FDA Received Date: 09/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Weight: 91