MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX? COLONIC; STENT, COLONIC, METALIC, EXPANDABLE

Model Number	M00565050
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a1502 captures the reportable event of stent positioning issue.Imdrf impact code f2301 captures the reportable event of additional device required.Block h11: investigation results: based on the available information, boston scientific could not confirm the reported event of stent positioning issue.The device was not returned for analysis as it remains implanted; therefore, a technical analysis could not be performed.However, stent positioning issue is noted within the instructions for use (ifu) as a possible adverse event associated with the use of the device.Device history record review: it was confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Device technical analysis: the device was not returned for analysis as it remains implanted; therefore, a technical analysis could not be performed.Risk review: a risk review of the wallflex enteral stents was completed and confirmed that the events of stent positioning issue and additional device required were defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.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 positioning issue is noted within the instructions for use (ifu) as a known possible adverse event related to the use of the device.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of known inherent risk of device.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex colonic stent was implanted into the colon to treat a stricture caused by cancer during a stent implantation procedure performed on (b)(6) 2026.The anatomy of the patient was torturous and was not dilated prior to stent placement.During procedure, a zebra guidewire was inserted into the narrowed cavity and passed to the distal end on the side of the lesion.Then, a stent pusher was introduced along the guidewire.Under the direct vision of the endoscope, it was confirmed and then slowly released.The bottom yellow mark of stent was not clearly marked.It was observed that the stent was not positioned properly, which caused some of the lesions to be not fully covered.To resolve the issue, a non-boston scientific stent was added on the anal side of the lesion.The procedure was completed using the original device.There were no patient complications as a result of this event.

• Brand Name: WALLFLEX? COLONIC
• Common Device Name: STENT, COLONIC, METALIC, EXPANDABLE
• 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: 24559708
• Report Number: 3005099803-2026-00877
• Device Sequence Number: 8828393
• Product Code: MQR
• UDI-Device Identifier: 08714729456520
• UDI-Public: (01)08714729456520(17)270120(10)35666888
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K201159
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/10/2026

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 Model Number: M00565050
• Device Catalogue Number: M00565050
• Device Lot Number: 0035666888
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 03/10/2026
• Date Device Manufactured: 01/20/2025
• 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 Age: 87 YR
• Patient Sex: Female