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

Model Number	M00570340
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Dehydration (1807); Jaundice (2187); No Code Available (3191)
Date of Event	02/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; 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 30, 2020 that a wallflex biliary rx fully covered rmv stent was implanted in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2019.According to the complainant, on (b)(6) 2020, the patient returned to the hospital and the stent was noted to have migrated out.A plastic stent was implanted to ensure drainage.On (b)(6) 2020, another wallflex biliary stent was implanted.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.Note: despite efforts, boston scientific has been unable to obtain additional information regarding the circumstances surrounding this event to date.Should additional relevant details become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Blocks b5 and h6 (patient codes) have been updated with additional information received on (b)(6), 2020.Block h6: patient code 2187 captures the reportable patient issue of jaundice patient code 1807 captures the reportable patient issue of dehydration patient code 3191 captures the placement of a plastic stent and a second wallflex biliary stent.Problem code 4003 captures the reportable event of stent migration.Block h10: the complainant indicated that the device was disposed and will not be returned for evaluation; 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 (b)(6), 2020 that a wallflex biliary rx fully covered rmv stent was implanted in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2019.According to the complainant, on (b)(6), 2020, the patient returned to the hospital and the stent was noted to have migrated out.A plastic stent was implanted to ensure drainage.On (b)(6), 2020, another wallflex biliary stent was implanted.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.***additional information received on (b)(6), 2020*** it was reported that the wallflex biliary rx fully covered rmv stent was indicated to treat a malignant stricture in the distal bile duct.According to the complainant, the patient presented with dehydration and jaundice.A computerized tomography (ct) scan was performed and confirmed that the stent had completely migrated and passed out naturally from the patient.Per the physician, the stricture likely shrank due to chemotherapy.

• 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: 9977433
• Report Number: 3005099803-2020-01681
• Device Sequence Number: 19575384
• Product Code: PNB
• UDI-Device Identifier: 08714729953159
• UDI-Public: 08714729953159
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: DEN150040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2020

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: 04/16/2021
• Device Model Number: M00570340
• Device Catalogue Number: 7034
• Device Lot Number: 0023660687
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/30/2020
• Supplement Date Received by Manufacturer: 04/23/2020
• Initial Report FDA Received Date: 04/20/2020
• Supplement Report FDA Received Date: 05/14/2020
• 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
• Patient Age: 67 YR
• Patient Weight: 58