MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX DUODENAL; STENT,METALLIC,EXPANDABLE,DUODENAL

Model Number	M00565020
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block g4: premarket/510(k): k062750, k201159 - reported here as it exceeded the maximum character limit for the designated field.Block h6: imdrf device code a150101 is being used to capture the reportable event of stent failure to expand.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex enteral duodenal stent was implanted to treat a 2 cm malignant duodenal stenosis during a colonoscopy with duodenal stent placement procedure performed on (b)(6) 2024.The patient's anatomy was not tortuous.During the procedure, the stent was fully deployed in the correct location.However, it was reported that the stent was removed from the patient using rat tooth forceps.The procedure was completed with another wallflex duodenal stent.Due to the ambiguity of the event, boston scientific considered the worst-case scenario: the stent was unable to expand during the procedure.No patient complications were reported as a result of this event.

• Brand Name: WALLFLEX DUODENAL
• Common Device Name: STENT,METALLIC,EXPANDABLE,DUODENAL
• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 21212235
• Report Number: 3005099803-2025-00145
• Device Sequence Number: 8157269
• Product Code: MUM
• UDI-Device Identifier: 08714729456490
• UDI-Public: 08714729456490
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K062750
• 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
• Report Date (Section B): 01/22/2025

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: M00565020
• Device Catalogue Number: M00565020
• Device Lot Number: 0035044960
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2025
• Initial Report FDA Received Date: 01/22/2025
• 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 Sex: Unknown