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

Model Number	M00565060
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf impact code f1001 captures the reportable event of a cancelled/rescheduled procedure.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex colonic stent was to be implanted to treat a malignant colonic stricture during a colonic stenting procedure performed on (b)(6) 2025.During the procedure, the physician attempted to deploy the stent over the guidewire; however, under fluoroscopic guidance, it was observed that the stent was not fully expanding.Approximately 80% of the stent had been deployed when the problem was identified.The stent was subsequently removed and inspected externally, where it was found to partially open but not as expected.As a result, the procedure was rescheduled.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf impact code f1001 captures the reportable event of a cancelled/rescheduled procedure block h11: investigation results: based on the available information, boston scientific corporation did not confirm the reported event of stent partially deployed.The returned device was received with the stent fully covered and undeployed, visual inspection identified no damage or abnormalities to the stent or delivery system, and functional testing demonstrated that the device deployed normally without resistance.Device history record 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: a wallflex enteral stent was returned for analysis.A media review of the photograph provided by the complainant noted that the documentation attached to the complaint included an image showing the product packaging, including the product label and associated product information.A visual examination of the returned device was performed.The device was carefully inspected and no damages or abnormalities were observed.Functional testing was conducted on the delivery system.The device was received with the stent fully covered and undeployed.As a result, functional testing related to stent deployment was performed by actuating the delivery system (sliding the handle back along the stainless-steel tube).The deployment mechanism functioned as intended and no resistance was encountered during actuation.No damages or functional issues were identified with the stent or delivery system during the evaluation.Risk review: a risk review of the wallflex enteral stent was completed and confirmed that the events of "stent partially deployed" and "cancelled/rescheduled - post sedation/sedation unknown" 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 device problem excluded.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex colonic stent was to be implanted to treat a malignant colonic stricture during a colonic stenting procedure performed on (b)(6) 2025.During the procedure, the physician attempted to deploy the stent over the guidewire; however, under fluoroscopic guidance, it was observed that the stent was not fully expanding.Approximately 80% of the stent had been deployed when the problem was identified.The stent was subsequently removed and inspected externally, where it was found to partially open but not as expected.As a result, the procedure was rescheduled.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h11 was corrected, labeling review section was not included in previous report.Block h6: imdrf impact code f1001 captures the reportable event of a cancelled/rescheduled procedure.Block h11: investigation results: based on the available information, boston scientific corporation did not confirm the reported event of stent partially deployed.The returned device was received with the stent fully covered and undeployed, visual inspection identified no damage or abnormalities to the stent or delivery system, and functional testing demonstrated that the device deployed normally without resistance.Device history record 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: a wallflex enteral stent was returned for analysis.A media review of the photograph provided by the complainant noted that the documentation attached to the complaint included an image showing the product packaging, including the product label and associated product information.A visual examination of the returned device was performed.The device was carefully inspected and no damages or abnormalities were observed.Functional testing was conducted on the delivery system.The device was received with the stent fully covered and undeployed.As a result, functional testing related to stent deployment was performed by actuating the delivery system (sliding the handle back along the stainless-steel tube).The deployment mechanism functioned as intended and no resistance was encountered during actuation.No damages or functional issues were identified with the stent or delivery system during the evaluation.Labeling review: a labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.Risk review: a risk review of the wallflex enteral stent was completed and confirmed that the events of "stent partially deployed" and "cancelled/rescheduled - post sedation/sedation unknown" 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 device problem excluded.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex colonic stent was to be implanted to treat a malignant colonic stricture during a colonic stenting procedure performed on (b)(6) 2025.During the procedure, the physician attempted to deploy the stent over the guidewire; however, under fluoroscopic guidance, it was observed that the stent was not fully expanding.Approximately 80% of the stent had been deployed when the problem was identified.The stent was subsequently removed and inspected externally, where it was found to partially open but not as expected.As a result, the procedure was rescheduled.There were no patient complications reported 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: 22561673
• Report Number: 3005099803-2025-03512
• Device Sequence Number: 4021771
• Product Code: MQR
• UDI-Device Identifier: 08714729456537
• UDI-Public: (01)08714729456537(17)260410(10)33795378
• 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): 03/29/2026

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 Expiration Date: 04/10/2026
• Device Model Number: M00565060
• Device Catalogue Number: M00565060
• Device Lot Number: 0033795378
• 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: 06/26/2025
• Supplement Date Received by Manufacturer: 02/16/2026; 03/17/2026
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 03/16/2026; 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2024
• 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 Age: 54 YR
• Patient Sex: Male
• Patient Weight: 48 KG