MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLSTENT ENTERNAL PROSTHESIS; STENT, COLONIC, METALIC, EXPANDABLE

Device Problems Use of Device Problem (1670); Migration (4003); Device Stenosis (4066)

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Perforation (2001)

Event Date 01/01/2015

Event Type  Injury  

Manufacturer Narrative

Date of event: exact date unknown, event occurred between (b)(6) 2015 to (b)(6) 2020.Literature source: ruben s-a., jose carlos i., belen martinez m., joan g., et al.Eijs-guided gastroenterostomy versus duodenal self-expandable metal stent for malignant gastric outlet obstruction: results from a nationwide multicenter retrospective study.Gastrointestinal endoscopy; 2022; 96:1012-20.Initial reporter address 1: (b)(6).(b)(4).

Event Description

Boston scientific corporation became aware of the following event from referenced literature article "eus-guided gastroenterostomy versus duodenal self-expandable metal stent for malignant gastric outlet obstruction: results from a nationwide multicenter retrospective study." according to the literature, a wallflex duodenal stent was implanted to treat a gastric outlet obstruction during a duodenal stenting procedure performed on an unknown date.It was reported that the patient experienced tumor in or overgrowth, migration and pancreatitis and/or cholangitis.Unspecified wallflex malfunctions occurred during patient surveillance which were treated with 1:1 placement of a second wallflex stent, endoscopic ultrasound guided gastroenterostomy, and surgical gastrojejunostomy.It was further reports that the patient experienced perforation, which was treated with palliative care, severe bleeding requiring blood transfusion and admission to the intensive care unit.Note: it was reported that the wallflex enteral stent was intended to be placed to treat a gastric outlet obstruction.However, per the the wallflex enteral duodenal stent with anchor lock delivery system is indicated for the palliative treatment of gastroduodenal obstructions produced by malignant neoplasms.The wallflex enteral stent is not indicated to be implanted in gastric outlet obstruction.

• Brand Name: WALLSTENT ENTERNAL PROSTHESIS
• Type of Device: STENT, COLONIC, METALIC, EXPANDABLE
• 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: 16126078
• MDR Text Key: 306982517
• Report Number: 3005099803-2022-07880
• Device Sequence Number: 1
• Product Code: MQR
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/09/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2022
• Initial Date FDA Received: 01/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention