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

Model Number	M00570360
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
It was reported to boston scientific corporation that a wallflex biliary stent was to be implanted during an endoscopic retrograde cholangiopancreatography (ercp) to treat a malignant stricture from chronic pancreatitis performed on (b)(6) 2020.According to the complainant, during the procedure the stent was able to be deployed without issue but it was noted that the stent was not fully expanded.The stent was removed with graspers, and the procedure was completed with another wallflex biliary stent.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: device code 3270 is used to capture the reportable event of stent failure to expand.Block h10: the returned wallflex biliary stent was analyzed, and a visual evaluation noted that the delivery system was not returned and the stent was returned in good condition.A dimensional evaluation confirmed that the outer diameter (od) of the stent was measured within specification.No other issues with the device were noted.The reported event of stent failure to expand was not confirmed because the stent was returned in good condition and the delivery system was not returned so a functional test could not be performed.Therefore, a review and analysis of all available information indicated that the most probable root 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.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary stent was to be implanted during an endoscopic retrograde cholangiopancreatography (ercp) to treat a malignant stricture from chronic pancreatitis performed on (b)(6) 2020.According to the complainant, during the procedure the stent was able to be deployed without issue but it was noted that the stent was not fully expanded.The stent was removed with graspers, 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: 9753037
• Report Number: 3005099803-2020-00630
• Device Sequence Number: 2574469
• Product Code: PNB
• UDI-Device Identifier: 08714729953173
• UDI-Public: 08714729953173
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/21/2020

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: 10/31/2021
• Device Model Number: M00570360
• Device Catalogue Number: 57036
• Device Lot Number: 0024696762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2020
• Initial Date Received by Manufacturer: 01/29/2020
• Supplement Date Received by Manufacturer: 04/01/2020
• Initial Report FDA Received Date: 02/26/2020
• Supplement Report FDA Received Date: 04/21/2020
• 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