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

Model Number	M00570380
Medical Device Problem Codes	Material Deformation (2976); Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2019 that a wallflex biliary rx fully covered rmv stent was to be used in the common bile duct during a endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the stent was able to be deployed; however, it was noted that the stent was short for the patient's anatomy.The stent was attempted to be pulled down but the stent looks like it kinked.The stent was removed and another wallflex biliary stent was placed to complete the procedure.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.
Additional Manufacturer Narrative
Block h6: problem code 3009 captures the reportable event of stent positioning problem.Problem code 2976 captures the reportable event of stent material deformation.Block h10: a wallflex biliary fully covered rmv stent was returned for analysis; the delivery system was not returned.Visual examination of the returned device found the stent was received kinked at 45mm of the proximal end.The reported event of stent kinked was confirmed.Taking all available information into consideration, the investigation concluded that the reported event and the observed failure was likely due to procedural factors such as how the device was handled and manipulated or the quantity of force applied in the attempt to pull the stent down during the procedure, the techniques used by the user, and normal procedural difficulties encountered during the procedure which affects the performance of the device.Therefore, the most probable cause is adverse event related to the 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 2019 that a wallflex biliary rx fully covered rmv stent was to be used in the common bile duct during a endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the stent was able to be deployed; however, it was noted that the stent was short for the patient's anatomy.The stent was attempted to be pulled down but the stent looks like it kinked.The stent was removed and another wallflex biliary stent was placed to complete the procedure.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.

• 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: 9575506
• Report Number: 3005099803-2020-00018
• Device Sequence Number: 2937017
• Product Code: PNB
• UDI-Device Identifier: 08714729953197
• UDI-Public: 08714729953197
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 03/03/2020

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: 09/24/2021
• Device Model Number: M00570380
• Device Catalogue Number: 7038
• Device Lot Number: 0024488412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2020
• Initial Date Received by Manufacturer: 12/18/2019
• Supplement Date Received by Manufacturer: 02/05/2020
• Initial Report FDA Received Date: 01/10/2020
• Supplement Report FDA Received Date: 03/03/2020
• 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