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

Model Number	M00565020
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a0406 captures the reportable event of stent material deformation.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex enteral duodenal stent was to be implanted in the intestinal tract to treat stenosis secondary to metastasis of the left colon tumor during an endoscopic intestinal stent implantation procedure performed on (b)(6) 2023.During the procedure, the stent was noted to be bent and kinked after placement.Subsequent remediation was carried out.The stent was removed from the patient, and the procedure was completed with another wallflex enteral duodenal stent.There were no patient complications reported as a result of this event, and the patient's condition after the procedure was reported to be stable.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex enteral duodenal stent was to be implanted in the intestinal tract to treat stenosis secondary to metastasis of the left colon tumor during an endoscopic intestinal stent implantation procedure performed on (b)(6) 2023.During the procedure, the stent was noted to be bent and kinked after placement.Subsequent remediation was carried out.The stent was removed from the patient, and the procedure was completed with another wallflex enteral duodenal stent.There were no patient complications reported as a result of this event, and the patient's condition after the procedure was reported to be stable.***additional information received on february 28, 2024 and march 20, 2024*** it was reported that the stent was successfully deployed and implanted inside the patient when the stent was found to be deformed, bent, kinked, and not fully deployed.The stent was not removed from the patient and a second stent was inserted to help keep it deployed.It was reported that surgery will be performed later.In addition, it was reported that the patient has ileus and that it is not an underlying condition.However, there is no was information regarding the exact relationship between the patient's condition of ileus and the wallflex enteral duodenal stent and if an intervention was required.
Additional Manufacturer Narrative
Blocks b5 and h6 have been updated with the additional information received on february 28, 2024.Block h6: imdrf device code a0406 captures the reportable event of stent material deformation.

• 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: 18771230
• Report Number: 3005099803-2024-00555
• Device Sequence Number: 7701514
• 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
• 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): 03/26/2024

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: 05/31/2024
• Device Model Number: M00565020
• Device Catalogue Number: 6502
• Device Lot Number: 0029507183
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/30/2024
• Supplement Date Received by Manufacturer: 02/28/2024
• Initial Report FDA Received Date: 02/23/2024
• Supplement Report FDA Received Date: 03/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 60 KG