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

Model Number	M00565030
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Constipation (3274)
Date of Event	07/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2023, that a wallflex enteral duodenal stent was to be implanted in the duodenum to treat a malignant duodenal stenosis due to cancer during a duodenal stent placement procedure performed on (b)(6), 2023.The patient's anatomy was tortuous and was not dilated prior to stent placement.During the procedure, the white handle broke and the stent did not deploy.The stent was removed from the patient, and the procedure was not completed.Two (2) days later, another wallflex enteral duodenal stent was implanted in the patient.Reportedly, the patient experienced constipation; however, there is no available information to confirm that a medical or surgical intervention was performed outside the scope of the original procedure or that the reported malfunction of the wallflex enteral duodenal stent caused or contributed to the patient's constipation.Additionally, the patient was not admitted beyond the standard days of hospital care.
Additional Manufacturer Narrative
Block h6: impact code f05 is being used to capture the reportable event of a cancelled/rescheduled procedure.
Event or Problem Description
It was reported to boston scientific corporation on july 13, 2023, that a wallflex enteral duodenal stent was to be implanted in the duodenum to treat a malignant duodenal stenosis due to cancer during a duodenal stent placement procedure performed on (b)(6) 2023.The patient's anatomy was tortuous and was not dilated prior to stent placement.During the procedure, the white handle broke and the stent did not deploy.The stent was removed from the patient, and the procedure was not completed.Two (2) days later, another wallflex enteral duodenal stent was implanted in the patient.Reportedly, the patient experienced constipation; however, there is no available information to confirm that a medical or surgical intervention was performed outside the scope of the original procedure or that the reported malfunction of the wallflex enteral duodenal stent caused or contributed to the patient's constipation.Additionally, the patient was not admitted beyond the standard days of hospital care.
Additional Manufacturer Narrative
Block h6: impact code f05 is being used to capture the reportable event of a cancelled/rescheduled procedure.Block h10: the wallfflex enteral duodenal stent and delivery system were received for analysis.Visual inspection found that the stent was fully covered by the outer sheath and undeployed from the delivery system.The outer sheath was slightly pushed off the tip, buckled, and stretched.The stainless-steel handle was detached from the hub and bent.A functional inspection was not performed due to the condition of the stainless steel handle being detached from the hub.No other damages were noted with the stent or the delivery system.Product analysis confirmed the reported events.The investigation concluded that stent failure to deploy, handle break, and the additional investigation findings of handle bent, outer sheath buckled, and stretched were most likely due to procedural factors such as lesion characteristics, handling of the device, and the technique used by the physician (force applied), which could have resulted in the damages noted on the device and prevented the stent from deploying during the procedure.Therefore, a review and analysis of all available information indicated that the most probable cause is adverse event related to procedure.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: 17436518
• Report Number: 3005099803-2023-04150
• Device Sequence Number: 8913470
• Product Code: MUM
• UDI-Device Identifier: 08714729456506
• UDI-Public: 08714729456506
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 10/23/2023

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: 01/20/2024
• Device Model Number: M00565030
• Device Catalogue Number: 6503
• Device Lot Number: 0028712683
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/13/2023
• Supplement Date Received by Manufacturer: 10/03/2023
• Initial Report FDA Received Date: 08/01/2023
• Supplement Report FDA Received Date: 10/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2022
• 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