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

Model Number	M00565050
Medical Device Problem Codes	Positioning Failure (1158); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf impact code f1001 captures the reportable event of cancelled procedure.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex enteral colonic stent was implanted in the colon to treat a colonic stricture due to cancer during metal stenting procedure performed on (b)(6) 2025.The patient's anatomy was tortuous and was dilated prior to stent placement.During procedure, the stent failed to open while trying to open the stent at the stricture site.The physician attempted multiple times to deploy the stent however it did not open.The procedure was not completed as it was aborted.There were no patient complications as a result of the event.
Additional Manufacturer Narrative
Block e1: initial reporter address: (b)(6); reported here as the address exceeded character limit for the designated field.Block h6: imdrf impact code f1001 captures the reportable event of cancelled procedure.Block b5: has been updated with the additional information received on may 16, 2025.Block e1 initial reporter facility name and initial reported address has been updated with the additional information received on may 16, 2025.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex enteral colonic stent was implanted in the colon to treat a colonic stricture due to cancer during metal stenting procedure performed on (b)(6) 2025.The patient's anatomy was tortuous and was dilated prior to stent placement.During procedure, the stent failed to open while trying to open the stent at the stricture site.The physician attempted multiple times to deploy the stent however it did not open.The procedure was not completed as it was aborted.There were no patient complications as a result of the event.Additional information received on may 16, 2025: the type of procedure performed was colonoscopy.
Additional Manufacturer Narrative
Block e1: initial reporter address: (b)(6).Block h6: imdrf impact code f1001 captures the reportable event of cancelled procedure.Block h11: a wallflex colonic stent and delivery system was received for analysis.A visual examination of the returned device found the stent partially deployed, therefore the functional testing related to the deployment of the stent, by actuating the delivery system (slide the handle back along the stainless-steel tube) was performed and high resistance was felt.The stent was not able to be deployed due to the stainless steel was found kinked.Also, the blue outer sheath was found unraveled and kinked.The product analysis confirmed the reported event of stent failure to deploy, as the device returned with the stent partially deployed, therefore the functional testing related to the deployment of the stent, by actuating the delivery system (slide the handle back along the stainless-steel tube) was performed and high resistance was felt.The stent was not able to be deployed due to the stainless steel was found kinked.Also, the blue outer sheath was found unraveled and kinked.Most likely procedural factors as lesion characteristics, handling of the device, the technique used by the physician, could have resulted in the damages encountered to the device, these damages could unable deployment of the stent during the procedure causing partially deployment.For the reported event of cancelled/rescheduled - post sedation/sedation unknown, this event cannot be confirmed as this happened during the procedure and there is no way to replicate it in the laboratory and there is no objective evidence or descriptive information available to establish the cause of the reported event.Therefore, a review and analysis of all available information indicated that the most probable cause is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex enteral colonic stent was implanted in the colon to treat a colonic stricture due to cancer during colonoscopy with metal stenting procedure performed on (b)(6) 2025.The patient's anatomy was tortuous and was dilated prior to stent placement.During procedure, the stent failed to open while trying to open the stent at the stricture site.The physician attempted multiple times to deploy the stent however it did not open.The procedure was not completed as it was aborted.There were no patient complications as a result of the 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: 21939652
• Report Number: 3005099803-2025-01947
• Device Sequence Number: 18406139
• Product Code: MQR
• UDI-Device Identifier: 08714729456520
• UDI-Public: (01)08714729456520(17)261118(10)35304722
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/26/2025

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: M00565050
• Device Catalogue Number: M00565050
• Device Lot Number: 0035304722
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2025
• Supplement Date Received by Manufacturer: 05/16/2025; 11/02/2025
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 06/10/2025; 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2024
• 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
• Patient Sex: Male