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

Model Number M00570490

Device Problems Break (1069); Difficult to Remove (1528); Use of Device Problem (1670); Material Deformation (2976); Migration (4003)

Patient Problems Pseudoaneurysm (2605); Pancreatitis (4481)

Event Date 01/31/2024

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a wallflex biliary fully covered rmv stent was implanted in the common bile duct to treat a bile leak during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on an unknown date.Six months post stent placement procedure, it was noted that the stent migrated proximally.The stent was attempted to be swept down with a balloon, but the balloon popped because the stent was deformed and broken.The physician made another attempt to remove the stent using forceps but was also unsuccessful.Reportedly, the damage observed on the stent could have occurred between (b)(6) 2023, given that the patient underwent an embolization procedure on (b)(6) 2023.On (b)(6) 2024, the patient was rescheduled for another procedure and the physician was able to successfully remove the stent using a snare.The patient experienced pancreatitis and splenic artery pseudoaneurysm and was admitted to the hospital beyond standard of care.In the physician's assessment, the patient's complication is related to the device and procedure.

Manufacturer Narrative

Block d4, h4: the complainant was unable to provide the suspect device upn and lot number.Therefore, the manufacture and expiration dates are unknown.Block e1: the reported healthcare facility is: (b)(6) hospital.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 a150207 captures the reportable event of stent difficult to remove.Imdrf device code a0406 captures the reportable event of stent material deformation.Imdrf patient code e1021 captures the reportable event of pancreatitis.Imdrf patient code e0513 captures the reportable event of pseudoaneurysm.Imdrf impact code f08 captures the reportable event of prolonged hospitalization.Imdrf impact code f23 captures the reportable event of additional intervention performed to remove the stent.

• Brand Name: WALLFLEX BILIARY RX STENT SYSTEM
• Type of Device: 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: 18751382
• MDR Text Key: 335900479
• Report Number: 3005099803-2024-00621
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K223469
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/13/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00570490
• Device Catalogue Number: 7049
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention