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

Model Number	M00565040
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2025
Type of Reportable Event	Malfunction
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 3 cm tumor due to colonic cancer during an intestinal stent implantation procedure performed on (b)(6) 2025.The patient's anatomy was tortuous.During procedure, the supporting force of the inner sheath was not enough, resulting for the stent being not able to deploy.When the stent was removed from the patient it was noted that the stent was partially deployed.The procedure was completed with another of the same device.There was no patient complications reported as a result of the event and the condition of the patient was reported to be stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a15 captures the reportable event of stent partially deployed.
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 3 cm malignant tumor due to colonic cancer during an intestinal stent implantation procedure performed on (b)(6) 2025.The patient's anatomy was tortuous.During procedure, the supporting force of the inner sheath was not enough, resulting for the stent being not able to deploy.When the stent was removed from the patient it was noted that the stent was partially deployed.The procedure was completed with another of the same device.There was no patient complications reported as a result of the event and the condition of the patient was reported to be stable.
Additional Manufacturer Narrative
Block e1 (initial reporter address 1, initial reporter address 2, initial reporter city, and initial reporter zip code) has been corrected.Block h6: imdrf device code a15 captures the reportable event of stent partially deployed.Block h11: a wallflex enteral colonic delivery system was received for analysis; the stent was not returned.Visual examination of the returned device revealed that the inner sheath was kinked.No other problems were noted with the delivery system.Product analysis did not confirm the reported event of stent partially deployed.It is most likely that procedural factors such as lesion characteristics, handling of the device, and the technique used by the physician resulted in the observed event of inner sheath kinked.However, stent partially deployed was not confirmed since there was no objective evidence to confirm the reported problem.Therefore, a review and analysis of all available information indicated the most probable cause is no problem detected.

• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21890810
• Report Number: 3005099803-2025-01777
• Device Sequence Number: 16995538
• Product Code: MQR
• UDI-Device Identifier: 08714729456513
• UDI-Public: (01)08714729456513(17)260814(10)34636941
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K061877
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2025

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 Expiration Date: 08/14/2026
• Device Model Number: M00565040
• Device Catalogue Number: M00565040
• Device Lot Number: 0034636941
• 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: 03/26/2025
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2024
• 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: 64 YR
• Patient Sex: Male
• Patient Weight: 79 KG