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

Model Number	M00570370
Medical Device Problem Codes	Break (1069); Material Deformation (2976); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a010402 captures the reportable event of stent migration.Imdrf device code a0406 captures the reportable event of stent material deformation.Imdrf device code a0401 captures the reportable event of stent break.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary fully covered rmv stent was implanted in the bile duct to treat a malignant biliary stricture during a stent placement procedure performed on (b)(6) 2023.The patient's anatomy was not tortuous and was not dilated prior to stent placement.On (b)(6) 2024, the stent was scheduled to be removed during an endoscopic retrograde cholangiopancreatography (ercp) procedure.During the procedure, it was noted that the stent had migrated proximally into the common bile duct and was attempted to be retrieved using a rat-tooth grasper.The physician then dilated the papilla and pulled the stent down with a balloon and rat-tooth grasper.However, the stent broke during this time and began to unravel completely.The stent was eventually removed but the procedure was extended for 2 hours.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Blocks g4 (premarket / 510(k) #) and h6 (impact codes) have been corrected.Block h6: imdrf device code a010402 captures the reportable event of stent migration.Imdrf device code a0406 captures the reportable event of stent material deformation.Imdrf device code a0401 captures the reportable event of stent break.Imdrf device code f2301 captures the event of the additional device required to dilate the papilla and remove the stent.Block h11: investigation results: based on the available information, boston scientific was able to confirm the reported events of stent material deformation and stent break based on a review of device photographs provided, which showed that the stent was deformed and broken.In addition, stent migration is noted within the instructions for use (ifu) as a possible adverse event associated with the use of the device.However, the reported event of stent migration could not be confirmed.The investigation concluded that the reported events were most likely caused by procedural factors such as lesion characteristics, handling of the device, and the technique used by the physician (force applied).Device history record (dhr) review: it was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Device technical analysis: the complaint device was not returned for evaluation; therefore, a technical analysis could not be performed.However, images were provided where it can be observed the stent deformed and broken.Labeling review: a labeling review was performed and, from the information available, there is no information that this device was used in a manner inconsistent with the instructions for use (ifu)/ product label.Additionally, stent migration is noted within the ifu as a known possible adverse event related to the use of the device.Risk review: a risk review was completed and confirmed that the reported events of stent migration, stent material deformation and stent break were defined in the risk documentation.These event types have been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary fully covered rmv stent was implanted in the bile duct to treat a malignant biliary stricture during a stent placement procedure performed on (b)(6) 2023.The patient's anatomy was not tortuous and was not dilated prior to stent placement.On (b)(6) 2024, the stent was scheduled to be removed during an endoscopic retrograde cholangiopancreatography (ercp) procedure.During the procedure, it was noted that the stent had migrated proximally into the common bile duct and was attempted to be retrieved using a rat-tooth grasper.The physician then dilated the papilla and pulled the stent down with a balloon and rat-tooth grasper.However, the stent broke during this time and began to unravel completely.The stent was eventually removed but the procedure was extended for 2 hours.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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 19631198
• Report Number: 3005099803-2024-03094
• Device Sequence Number: 15594246
• Product Code: PNB
• UDI-Device Identifier: 08714729953180
• UDI-Public: (01)08714729953180(17)241114(10)30539234
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K240464
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2026

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: 11/14/2024
• Device Model Number: M00570370
• Device Catalogue Number: M00570370
• Device Lot Number: 0030539234
• 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: 05/31/2024
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 04/21/2026
• Date Device Manufactured: 11/15/2022
• 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