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 Problems Partial Blockage (1065); Kinked (1339)

Patient Problems Hemorrhage/Bleeding (1888); Inflammation (1932); Perforation (2001); No Code Available (3191)

Event Date 03/31/2016

Event Type  Injury  

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.However, it was noted that 14 patients had the wallflex duodenal stent and 17 had the niti-s pyloric/duodenal d-type stent.Block f10: device component code 515 relates to the problem code 1339 for the reported event of stent kinked.Patient component code 3191 captures the reported events of surgery and hyperamylasemia.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.Four patients had early adverse events: hyperamylasemia in one, pancreatitis in one, and gastrointestinal perforation in one.One patient with gastrointestinal bleeding as a late adverse event had bleeding from a false aneurysm that had developed in a peripheral branch of the gastroduodenal artery.Hemostasis was achieved by transcatheter arterial embolization.The most common causes of recurrent duodenal obstruction (rdo) were stent kinking, tumor ingrowth and tumor overgrowth.One patient had an obstruction caused by mucosal hyperplasia which was not improved by stent placement and surgical gastrojejunostomy was performed.Six cases of kinking occurred, only in patients with wallflex duodenal stents.Re-intervention was attempted for 15 cases of rdo in 12 patients.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: 6407609
• MDR Text Key: 70031598
• Report Number: 3005099803-2017-00772
• 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: 03/15/2017
• 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): Required Intervention