MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX COLONIC SOFT STENT SYSTEM WITH ANCHOR LOCK DELIVERY SYSTEM; STENT, COLONIC, METALIC, EXPANDABLE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bowel Perforation (2668); Insufficient Information (4580)

Event Date 12/01/2022

Event Type  Injury  

Manufacturer Narrative

Date of event: approximated based on the date the manufacturer became aware of the event.The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.Literature source: maetani, i.How to successfully administer palliative treatment with a stent for malignant gastric outlet obstruction? front.Med.10.3389/fmed.2022.967740.(b)(4).

Event Description

Boston scientific became aware of events through the article "how to successfully administer palliative treatment with a stent for malignant gastric outlet obstruction?" by dr.Iruru maetani.According to the literature, on the "factors related to adverse events and stent dysfunction", an article by sasaki et al.On secondary gastroduodenal self-expanding metal stents placed for revision showed that a gastrointestinal perforation occurred in four of 29 patients; 3 patients had "wallflex in wallflex" stent placement and the other one had "niti-s (non-boston scientific stent) in wallflex" stent placement.Note: no further information has been obtained despite good faith efforts.

• Brand Name: WALLFLEX COLONIC SOFT STENT SYSTEM WITH ANCHOR LOCK DELIVERY SYSTEM
• 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: 16123401
• MDR Text Key: 306938964
• Report Number: 3005099803-2022-07971
• Device Sequence Number: 1
• Product Code: MQR
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2022
• 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): Other