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

Model Number	M00570360
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).According to the complainant, the stent remains implanted but the delivery system will be available for return.However, the device has not been received for analysis.Upon 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
It was reported to boston scientific corporation on january 15, 2021 that a wallflex biliary rx fully covered rmv stent was implanted in the common bile duct to treat a pancreatic cancer during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2021.Reportedly, the patient's anatomy was tight due to a pancreatic mass and was dilated with a 4x4 hurricane balloon prior to stent placement.According to the complainant, during the procedure, the stent deployed prematurely inside the patient and the stent did not bridge the ampulla.Reportedly, the physician felt comfortable leaving the stent implanted.Another wallflex biliary stent was placed stent-in-stent to bridge the ampulla and the procedure was completed.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation on (b)(4) 2021 that a wallflex biliary rx fully covered rmv stent was implanted in the common bile duct to treat a pancreatic cancer during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(4) 2021.Reportedly, the patient's anatomy was tight due to a pancreatic mass and was dilated with a 4x4 hurricane balloon prior to stent placement.According to the complainant, during the procedure, the stent deployed prematurely inside the patient and the stent did not bridge the ampulla.Reportedly, the physician felt comfortable leaving the stent implanted.Another wallflex biliary stent was placed stent-in-stent to bridge the ampulla and the procedure was completed.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: medical device problem code a150103 captures the reportable event of stent prematurely deployed.Block h10: a wallflex biliary rx delivery system was received for analysis; the stent was not returned.Visual examination of the returned device found the outer blue sheath was kinked, approximately 46 cm from the tip of the delivery system.The clear sheath was accordioned and the outer sheath was stretched out in the guidewire access sleeve (gas) section.The gas ramp was returned lifted.No other issues were noted to the delivery system.The damages noted to the returned device were most likely due to procedural and anatomical factors encountered during the procedure.It may be that the techniques used the by the user during insertion of the device through the scope, or the patient's tortuous anatomy, limited the performance of the device and contributed to the sheath kinked, damaged and accordioned.However, the reported event of stent prematurely deploy could not be confirmed as the stent was not returned.Additionally, this event occured during the procedure and it is not possible to replicate the functional failure during device analysis.Therefore, a review and analysis of all available information indicated the most probable cause is no problem detected.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

• 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: 11279404
• Report Number: 3005099803-2021-00367
• Device Sequence Number: 2688429
• Product Code: PNB
• UDI-Device Identifier: 08714729953173
• UDI-Public: 08714729953173
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: DEN150040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2021

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: 05/11/2022
• Device Model Number: M00570360
• Device Catalogue Number: 7036
• Device Lot Number: 0025502172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Initial Date Received by Manufacturer: 01/15/2021
• Supplement Date Received by Manufacturer: 02/22/2021
• Initial Report FDA Received Date: 02/04/2021
• Supplement Report FDA Received Date: 03/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1