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

Model Number	M00565110
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Incontinence (1928); Discomfort (2330); Fecal Incontinence (4571)
Date of Event	05/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation, that the patient was admitted to the hospital on (b)(6) 2025 and was diagnosed with a colorectal tumor with intestinal obstruction.The wallflex enteral stents was implanted in the rectum and sigmoid junction to treat a colorectal tumor during an intestinal stent implantation under digital subtraction angiography (dsa) procedure performed on (b)(6) 2025.Post implant procedure, the patient was discharged from the hospital on (b)(6) 2025; however, they experienced bowel movement failure.The stent could be felt migrated to the anus.On (b)(6) 2025, the patient was sent for surgery to remove the stent and place another of the same device.There was no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a010402 captures the reportable event of stent migration.Imdrf patient code e2324 captures the reportable patient complication of bowel incontinence.Imdrf impact code f19 captures the surgical procedure.
Additional Manufacturer Narrative
Blocks b5, b7, h6 (patient codes, impact codes), and h11 have been corrected.Block h6: imdrf device code a010402 captures the reportable event of stent migration.Imdrf patient code e232401 captures the reportable patient complication of bowel incontinence.Imdrf impact code f2202 captures the endoscopic procedure performed.Block h11: an axios stent was received for analysis; however, the delivery system was not returned.Visual examination of the returned device revealed that the stent was fully deployed, with no visible damage noted.A media inspection was conducted using a photo provided by the complainant, which included a ct scan showing the stent inside the patient's anatomy, as well as several images of the stent outside the patient's anatomy.However, the media evidence provided by the customer was limited and did not offer any additional details relevant to the device analysis.Product analysis did not confirm the reported event of stent migration.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 migration is a known potential complication associated with the use of the device in the manufacturer's labeling; therefore, the most probable root cause is known inherent risk of device.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex colonic stent was implanted in the rectosigmoid junction to treat a colorectal tumor during an intestinal stent implantation under digital subtraction angiography (dsa) performed on (b)(6) 2025.The procedure was successfully completed with no adverse events reported.Following the patient's discharge on (b)(6) 2025, symptoms indicating possible stent migration were reported, including absence of bowel movement and sensation of the stent at the anus.Imaging confirmed the migration.On (b)(6) 2025, the patient underwent an endoscopic procedure to remove the migrated stent and successfully implant a replacement.There was 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22197609
• Report Number: 3005099803-2025-02692
• Device Sequence Number: 9739312
• Product Code: MQR
• UDI-Device Identifier: 08714729456582
• UDI-Public: (01)08714729456582(17)261011(10)35044968
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K201159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 07/24/2025

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: M00565110
• Device Catalogue Number: M00565110
• Device Lot Number: 0035044968
• 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: 05/28/2025
• Supplement Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 50 KG