MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WallFlex? Colonic; stent, colonic, metalic, expandable

Model Number	M00555770
Medical Device Problem Codes	Break (1069); Activation, Positioning or Separation Problem (2906); Difficult to Advance (2920); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a wallflex? colonic stent was to be implanted to treat stenosis during a colonic stent placement procedure performed on (b)(6) 2026.During a standard colonic stent placement procedure, two stents experienced deployment issues and became stuck on the guidewire.Consequently, both stents, along with their respective delivery systems, were withdrawn and removed from the patient.One of the stents was reported to be partially deployed at the time of removal.The procedure was successfully completed using a different device and model.There were no patient complications as a result of this event and the patient condition following the procedure was stable.Note: this event has been deemed an mdr reportable event based on the investigation results which revealed that the stent was observed in a deformed condition with distortion of the stent structure.Additionally, breaks within the stent wire structure were identified, with multiple wire segments observed separated from the nominal stent configuration.Please see block h11 for full investigation details.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable investigation finding of stent break.Imdrf device code a0406 captures the reportable investigation finding of stent material deformation.Investigation results: boston scientific corporation could not confirm the reported events of stent partially deployed and device difficult to advance guidewire.The delivery system was not returned; only the stent was received for analysis.Although the complaint device was returned, only the stent was available for evaluation.The associated delivery system was not returned; therefore, product analysis and functional testing related to the reported guidewire advancement difficulty could not be performed.Without evaluation of the delivery system, it could not be determined whether the reported events were related to device performance, procedural technique, anatomical conditions, or other contributing factors.Device history record review: it was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which have contributed to the reported event device technical analysis: sample a wallflex colonic stent was returned for analysis.Only the stent was returned.A media inspection of the photo provided by the complainant noted that there is no evidence of the complaint device, packaging condition, or any device components relevant to the reported event, as the documentation provided consisted only of shipping and package documentation.A visual examination of the returned device revealed that only the stent was returned for evaluation.The stent was observed in a deformed condition with distortion of the stent structure.Additionally, breaks within the stent wire structure were identified, with multiple wire segments separated from the nominal stent configuration.Similar complaint review: a similar complaint review was completed.There were no emerging trends identified that warrant further action.Investigation conclusion: based on the available information, there is not enough evidence to confirm the cause of reported event.Without proper evaluation of the complaint device, cause not established is selected as the investigation conclusion code.

• 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 H91 Y 868; EI H91 Y868
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; +1(914)571-6918
• MDR Report Key: 50842567
• Report Number: 3005099803-2026-03885
• Device Sequence Number: 21347139
• Product Code: MQR
• UDI-Device Identifier: 08714729902591
• UDI-Public: (01)08714729902591(17)280419(10)39132691
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K200257
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00555770
• Device Catalogue Number: M00555770
• Device Lot Number: 0039132691
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/30/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2026
• 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
• Patient Sex: Unknown