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

Model Number	M00565030
Medical Device Problem Codes	Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a wallflex enteral duodenal stent was implanted to treat a 3-7 mm malignant lesion in the duodenum during an intestinal stent implantation procedure performed on (b)(6) 2024.The patient's anatomy was not tortuous and reportedly presented with abdominal pain.During the procedure, the stent tip became deformed (curved).The stent was removed from the patient fully covered by the outer sheath.The procedure was successfully completed using another wallflex enteral duodenal stent.No patient complications were reported as a result of this event, and the patient was stable at the conclusion of the procedure.
Additional Manufacturer Narrative
Block h6: imdrf device code a04 captures the reportable event of tip damaged/defective.
Additional Manufacturer Narrative
Block h6: imdrf device code a04 captures the reportable event of tip damaged/defective.Block h11: a wallflex duodenal stent and delivery system were received for analysis.The stent was returned fully covered and undeployed.Visual examination found the sheath was kinked.The tip was found in good condition.No other damages were noted to the stent and delivery system.Product analysis did not confirm the reported event of tip damaged.Taking all available information into consideration, there is no indication of what the customer reported because the tip was not damaged.Therefore, a review and analysis of all available information indicate the most probable cause is no problem detected.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex enteral duodenal stent was implanted to treat a 3-7 mm malignant lesion in the duodenum during an intestinal stent implantation procedure performed on (b)(6) 2024.The patient's anatomy was not tortuous and reportedly presented with abdominal pain.During the procedure, the stent tip became deformed (curved).The stent was removed from the patient fully covered by the outer sheath.The procedure was successfully completed using another wallflex enteral duodenal stent.No patient complications were reported as a result of this event, and the patient was stable at the conclusion of the procedure.

• 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: 21484644
• Report Number: 3005099803-2025-00691
• Device Sequence Number: 18251594
• Product Code: MUM
• UDI-Device Identifier: 08714729456506
• UDI-Public: (01)08714729456506(17)250226(10)31124417
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2025

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: 02/26/2025
• Device Model Number: M00565030
• Device Catalogue Number: M00565030
• Device Lot Number: 0031124417
• 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: 02/06/2025
• Supplement Date Received by Manufacturer: 04/08/2025
• Initial Report FDA Received Date: 02/27/2025
• Supplement Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2023
• 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: 58 YR
• Patient Sex: Male
• Patient Weight: 70 KG