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

Model Number	M00565010
Medical Device Problem Codes	Premature Activation (1484); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a150103 captures the reportable event of stent premature deployment.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex enteral duodenal stent was to be used during a stent placement procedure performed on an unknown date.During preparation, when opening the package, it was noted that the stent had already deployed.The procedure was completed with another device.There were no patient complications reported as a result of this event.Note: no further information has been obtained despite good faith efforts.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex enteral duodenal stent was to be used during a stent placement procedure performed on an unknown date.During preparation, when opening the package, it was noted that the stent had already deployed.The procedure was completed with another device.There were no patient complications reported as a result of this event.Note: no further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a150103 captures the reportable event of stent premature deployment.Block h11: a wallflex enteral duodenal stent and delivery system were received for analysis.The stent was received fully deployed and expanded.Visual inspection found that the outer clear sheath was kinked.No other problems were noted with the stent and delivery system.The observed event of sheath kinked was most likely due to procedural factors such as lesion characteristics, handling of the device, and the technique used by the physician (force applied).The reported event of stent premature deployment could not be confirmed, as it occurred during the procedure and cannot be replicated in the laboratory of analysis.Therefore, a review and analysis of all available information indicated the most probable cause is no problem detected.A product labeling review identified that the device was used per the instructions for use (ifu) / product label.

• 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: 20334687
• Report Number: 3005099803-2024-04817
• Device Sequence Number: 15860157
• Product Code: MUM
• UDI-Device Identifier: 08714729456483
• UDI-Public: 08714729456483
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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,Followup
• Report Date (Section B): 12/02/2024

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: 02/12/2025
• Device Model Number: M00565010
• Device Catalogue Number: 6501
• Device Lot Number: 0031035997
• 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: 09/04/2024
• Supplement Date Received by Manufacturer: 11/11/2024
• Initial Report FDA Received Date: 09/30/2024
• Supplement Report FDA Received Date: 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2023
• 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 Sex: Unknown