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 Kinked (1339)

Patient Problems Death (1802); Pneumonia (2011); Vomiting (2144)

Event Date 03/31/2016

Event Type  Death  

Manufacturer Narrative

Block a2: the mean age of patients who underwent stenting with the wallflex duodenal stent was 72 years (range 69-79 years).Block a3: 9 males and 5 females underwent stenting with the wallflex duodenal stent during this study.Block d4 and h4: the specific upn and lot number were not reported; therefore, the manufacture date and expiration date are unknown.Block f10: device component code 515 relates to the problem code 1339 for the reported event of stent kinked.Block g3: journal article: kosuke okuwaki, et al.¿randomized controlled exploratory study comparing the usefulness of two types of metallic stents with different axial forces for the management of duodenal obstruction caused by pancreatobiliary cancer¿ japanese society of hepato-biliary-pancreatic surgery 2016; 23:289-297.Doi http://dx.Doi.Org/10.1002/jhbp.341.Block h10: the devices have not been received for analysis; therefore 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 ¿randomized controlled exploratory study comparing the usefulness of two types of metallic stents with different axial forces for the management of duodenal obstruction caused by pancreatobiliary cancer¿ written by kosuke okuwaki, et al.(see citation in block h10).According to the literature, the aim of this study was to examine the effectiveness of duodenal stent placement (dsp) for duodenal obstruction (do) caused specifically by pancreatobiliary cancer.Two types of stents were compared with different axial forces (af) for do with pancreatobiliary cancer.Patients were randomly assigned to either the wallflex duodenal stent (boston scientifics) or the niti-s pyloric/duodenal d-type stent (taewoong medical co.).The study occurred from november 2012 through june 2015 with a total of 34 patients who were clinically diagnosed with malignant do.Of the 34 patients, 16 were assigned to the boston scientific group; two patients were found to not have severe do that required dsp, leaving 14 patients that underwent dsp.Twelve of the patients had tumors due to pancreatic cancer and 2 had tumors due to cancer of the ampulla of vater.According to the article, one experienced vomiting caused by recurrent duodenal obstruction due to kinking of the stent.This lead to the development of aspiration pneumonia, which subsequently led to the patient¿s death.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: 6404027
• MDR Text Key: 69914626
• Report Number: 3005099803-2017-00769
• Device Sequence Number: 1
• Product Code: MUM
• Combination Product (y/n): N
• 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
• Is this a Product Problem 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death