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

Model Number	M00570380
Medical Device Problem Codes	Failure to Advance (2524); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on march 17, 2020 that a wallflex biliary rx fully covered stent was to be used to treat a malignant stricture in th common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2020.Reportedly, the patient's anatomy was tight and was dilated prior to stent placement.According to the complainant, during the procedure, the physician was unable to advance the delivery system through the stricture.Reportedly, the stent was fully covered by the outer sheath when it was removed from the patient; however, it was noticed that the tip of the delivery system was bent.The procedure was completed with another wallflex biliary stent.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: device problem code 2978 captures the reportable event of tip bent.Block h10: investigation results a wallflex biliary rx fully covered rmv stent and delivery system were returned for analysis.The stent was received undeployed and was fully covered by the outer sheath.Visual examination of the returned device found the tip of the delivery system was deformed.The outer sheath was stretched out in the guidewire access sheath (gas) section and the gas ramp was lifted.No other issues with the stent and delivery system were noted.Taking all available information into consideration, the investigation concluded that the reported event and the observed failures are likely due to some factors encountered during the procedure, such as how the device was handled or manipulated, the interaction with the scope, the characteristics of the lesion, the amount of force applied to the delivery system, which limited the performance of the device.Therefore, the most probable cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly, and performance specifications at the time of release for distribution.A labeling review was performed, and from the information available, this device was used per the directions for use (dfu) / product label.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2020 that a wallflex biliary rx fully covered stent was to be used to treat a malignant stricture in th common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2020.Reportedly, the patient's anatomy was tight and was dilated prior to stent placement.According to the complainant, during the procedure, the physician was unable to advance the delivery system through the stricture.Reportedly, the stent was fully covered by the outer sheath when it was removed from the patient; however, it was noticed that the tip of the delivery system was bent.The procedure was completed with another wallflex biliary stent.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.

• 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: 9938258
• Report Number: 3005099803-2020-01471
• Device Sequence Number: 643841
• Product Code: PNB
• UDI-Device Identifier: 08714729953197
• UDI-Public: 08714729953197
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/10/2021
• Device Model Number: M00570380
• Device Catalogue Number: 7038
• Device Lot Number: 0024911212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2020
• Initial Date Received by Manufacturer: 03/17/2020
• Supplement Date Received by Manufacturer: 05/04/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 05/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1