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

Model Number	M00565010
Medical Device Problem Codes	Use of Device Problem (1670); Device Stenosis (4066)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block a2: the patient's exact age was not reported; however, the patient was reported to be over the age of 18.Block h6: imdrf device code a0106 captures the reportable event of stent obstruction within device.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex enteral duodenal stent was implanted in the pyloric channel and duodenal bulb to treat a benign gastroduodenal stricture during an upper gastrointestinal (gi) endoscopy with a stent placement procedure performed on (b)(6) 2023.The patient's anatomy was tortuous.The patient had two previously implanted boston scientific plastic stents which were scheduled for evaluation and removal on (b)(6) 2024.During the routine follow-up procedure, stent ingrowth was noted on the wallflex enteral stent.Consequently, a radiofrequency ablation procedure was performed using a habib device to get rid of the ingrowth.The stent remained implanted, and the procedure was completed.There were no patient complications reported as a result of this event.Note: it was reported that the wallflex enteral stent was implanted to treat a benign gastroduodenal stricture.However, per the wallflex duodenal stent system with anchor lock delivery system instructions for use (ifu), the device is indicated for the palliative treatment of gastroduodenal obstructions produced by malignant neoplasms.The device is not indicated to be placed for the treatment of benign stricture.

• 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: 18961145
• Report Number: 3005099803-2024-01215
• Device Sequence Number: 12533790
• Product Code: MUM
• UDI-Device Identifier: 08714729456483
• UDI-Public: 08714729456483
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K062750
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/22/2024

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 Expiration Date: 08/15/2025
• Device Model Number: M00565010
• Device Catalogue Number: 6501
• Device Lot Number: 0032224376
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/04/2024
• Initial Report FDA Received Date: 03/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown