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

Model Number	M00565020
Medical Device Problem Codes	Material Deformation (2976); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a wallflex enteral duodenal stent was implanted in the duodenum to treat a 5cm malignant stenosis during a stent placement procedure performed on (b)(6) 2024.The patient's anatomy was tortuous.During the procedure, the stent was deployed in the more distal part of the stenosis instead of the intended lesion site.Reportedly, the stent was scheduled to be removed one week after the procedure.Another wallflex enteral stent was used to complete the procedure.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a1502 captures the reportable event of stent positioning issue.
Additional Manufacturer Narrative
H6: imdrf device code a1502 captures the reportable event of stent positioning issue.H11: a wallflex enteral duodenal delivery system was received for analysis; the stent was not returned.Visual inspection found that the outer sheath and the handle were kinked.No other problems were noted with the delivery system.Product analysis did not confirm the reported event of stent positioning issue because this happened during the procedure and is not possible to be replicated in the laboratory of analysis.The observed events of outer sheath and handle kinked were most likely due to procedural factors such as handling of the device and the technique used by the physician.A product labeling review identified that the device was used per the instructions for use (ifu) / product label.Additionally, stent positioning issue is noted within the ifu as a potential adverse event associated with the use of the device.Therefore, taking all available information into consideration, the overall root cause of the reported event is known inherent risk of device.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex enteral duodenal stent was implanted in the duodenum to treat a 5cm malignant stenosis during a stent placement procedure performed on (b)(6) 2024.The patient's anatomy was tortuous.During the procedure, the stent was deployed in the more distal part of the stenosis instead of the intended lesion site.Reportedly, the stent was scheduled to be removed one week after the procedure.Another wallflex enteral stent was used to complete the procedure.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.

• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21119580
• Report Number: 3005099803-2024-06922
• Device Sequence Number: 8719195
• Product Code: MUM
• UDI-Device Identifier: 08714729456490
• UDI-Public: 08714729456490
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K062750
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 03/13/2025

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: 10/10/2025
• Device Model Number: M00565020
• Device Catalogue Number: M00565020
• Device Lot Number: 0032611784
• 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: 12/18/2024
• Supplement Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2023
• 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: 50 YR
• Patient Sex: Male
• Patient Weight: 70 KG