MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX BILIARY; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00570530
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Use of Device Problem (1670); Migration (4003)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	11/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number.Therefore, the manufacture and expiration dates are unknown.Block h6: imdrf device code a010402 captures the reportable event of stent migration.Imdrf device code a0401 captures the reportable event of stent break.Imdrf device code a1502027 captures the reportable event of stent difficult to remove.Imdrf patient code e0506 captures the reportable event of minor hemorrhage.Imdrf patient code e2342 captures the reportable event of multiple organ failure imdrf patient code e1002 captures the reportable event of abdominal pain imdrf impact code f2202 captures the reportable event of endoscopic attempts to position the stent imdrf impact code f2203 captures the reportable event of imaging showed a migrated stent.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary rx covered stent was implanted in the bile duct to address a persistent bile leak during a procedure performed in (b)(6) 2023.In (b)(6) 2024, the patient returned to the hospital for stent removal.During the procedure, the stent appeared broken, with the proximal part having migrated and passed out of the patient.Subsequently, the patient experienced bleeding, and a second stent was placed to achieve hemostasis.The first stent remained implanted.On (b)(6) 2024, the patient returned again for stent removal.During an endoscopic retrograde cholangiopancreatography (ercp) procedure, both stents were successfully removed using ped biopsy forceps.A spyglass was used to check for any retained product, and the procedure was completed.No patient complications were reported during the second stent removal.A photo of the complaint device was provided, showing two stents outside the patient.The first stent was broken in half.Note: it was reported that the wallflex biliary stent was implanted for a persistent bile leak.However, the wallflex biliary rx fully covered stent system instructions for use (ifu) state: "the wallflex biliary stent is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms and relief of malignant biliary obstruction prior to surgery, the physician did not follow the labeled indication.

• Brand Name: WALLFLEX BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 20780922
• Report Number: 3005099803-2024-05968
• Device Sequence Number: 9032634
• Product Code: FGE
• UDI-Device Identifier: 08714729764915
• UDI-Public: 08714729764915
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K140630
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/25/2024

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 Model Number: M00570530
• Device Catalogue Number: 7053
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2024
• Initial Report FDA Received Date: 11/26/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown