MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MOD M00565010; STENT,METALLIC,EXPANDABLE,DUODENAL

Model Number UNK476

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

Patient Problems Death (1802); Perforation (2001)

Event Date 06/03/2016

Event Type  Death  

Manufacturer Narrative

The mean age of patients included in the study was 72 years (range 28-98 years).The study included 249 patients: 126 males and 123 females.The specific upns and lot numbers were not reported; therefore, the manufacture date and expiration date are unknown.Literature source: little, m.W., et al."technical and clinical outcomes following colonic stenting: a seven-year analysis of 268 procedures." cardiovascular and interventional radiology 39.10 (2016): 1471-1478.Doi http://dx.Doi.Org/ 10.1007/s00270-016-1391-5.The devices have not been received for analysis; therefore a failure analysis of the complaint devices could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

Boston scientific corporation became aware of multiple events through the article "technical and clinical outcomes following colonic stenting: a seven-year analysis of 268 procedures" written by m.W.Little, et al.According to the literature, the aim of this study was to assess the factors contributing to the technical and clinical success of colorectal stenting for large bowel obstruction.In all cases, patients were implanted with a wallflex colonic stent between 2006 and 2013.The majority of patient strictures were due to malignant disease (244/268 strictures - 91%), with 19/268 (17%) resulting from extrinsic compression.24/268 (9%) were diverticular strictures.Seven (7) patients experienced a perforation at the stent site and died within 30 days of the procedure.The article did not provide any further information regarding these patients.If any additional information is received, a supplemental report will be filed.

• Brand Name: WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MOD M00565010
• Type of Device: STENT,METALLIC,EXPANDABLE,DUODENAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 6403992
• MDR Text Key: 69913068
• Report Number: 3005099803-2017-00747
• Device Sequence Number: 1
• Product Code: MUM
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K062750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK476
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2017
• Initial Date FDA Received: 03/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death