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

Model Number	M00570350
Medical Device Problem Codes	Break (1069); Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product investigation results: a fully constrained wallflex biliary rx fully covered rmv stent and delivery system were received for analysis.The stent was received fully covered by the outer sheath.Visual examination of the returned device found the outer sheath was detached/ broken at the outer diameter: proximal exterior tube-endoscope interface (proximal end of the gas section).Several kinks were identified in the inner member near the proximal end of the gas section.Functional evaluation revealed that it was not possible to deploy the stent using the delivery system as received; however, the stent was deployed by gripping the outer sheath and pulling the tip distally.No other issues were noted with the stent and delivery system.The damages noted with the returned device were consistent with the application of excessive force during use.The investigation concluded that the observed failures and the reported events were likely due to anatomical or procedural factors encountered during the procedure 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.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary rx fully covered rmv stent was to be used to treat a 5 cm malignant stricture in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2018.Reportedly, the patient's anatomy was tortuous and was dilated prior to stent placement.According to the complainant, during the procedure, the stent did not deploy.The stent was fully covered by the outer sheath when removed from the patient.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 fine.Note: this event has been deemed an mdr reportable event based on the investigation results which revealed that the outer sheath was detached/ broken at the outer diameter: proximal exterior tube- endoscope interface (proximal end of gas section.

• 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: 7967200
• Report Number: 3005099803-2018-60849
• Device Sequence Number: 11150999
• Product Code: PNB
• UDI-Device Identifier: 08714729953166
• UDI-Public: 08714729953166
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/15/2018

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: 04/16/2020
• Device Model Number: M00570350
• Device Catalogue Number: 56424
• Device Lot Number: 0021999110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2018
• Initial Report FDA Received Date: 10/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1