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

Model Number M00565020

Device Problem Device Stenosis (4066)

Patient Problems Abdominal Pain (1685); Nausea (1970)

Event Date 02/28/2023

Event Type  Injury  

Manufacturer Narrative

Imdrf device code a0106 captures the reportable event of stent occlusion.Imdrf patient code e1020 captures the reportable event of nausea.Imdrf patient code e1002 captures the reportable event of abdominal pain.Imdrf impact code f23 captures the reportable event of additional intervention performed to implant another stent inside the original stent.

Event Description

It was reported to boston scientific corporation on (b)(6) 2023, that a wallflex duodenal stent was to be implanted in the duodenum for palliative endoscopic stent treatment of gastroduodenal strictures during an upper gastrointestinal endoscopy procedure performed on (b)(6) 2022.On (b)(6) 2023, the patient experienced abdominal pain and nausea.On february 28, 2023, the stent was found occluded.An upper gastrointestinal endoscopy procedure was performed on (b)(6)2023, and a new stent was placed inside the original stent.The symptoms were relieved, and the patient was eventually discharged.

• Brand Name: WALLFLEX DUODENAL
• Type of Device: 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: 16708132
• MDR Text Key: 312963816
• Report Number: 3005099803-2023-01766
• Device Sequence Number: 1
• Product Code: MUM
• UDI-Device Identifier: 08714729456490
• UDI-Public: 08714729456490
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/10/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 02/25/2024
• Device Model Number: M00565020
• Device Catalogue Number: 6502
• Device Lot Number: 0028938886
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2023
• Initial Date FDA Received: 04/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention