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); Appropriate Term/Code Not Available (3191)

Patient Problems Hemorrhage/Bleeding (1888); Perforation (2001)

Event Date 10/17/2016

Event Type  Injury  

Manufacturer Narrative

The mean age of patients included in the study was 70.2 years (range 38-97 years).Seventy-one (71) males and 54 females were included in the study.The specific upns and lot numbers were not reported; therefore, the manufacture dates and expiration dates are unknown.However, it was noted that 46 patients had the wallflex duodenal stent and 79 had the niti-s pyloric/duodenal stent.(b)(4).Journal article: kato, hironari, et al."outcome of self-expandable metallic stent deployment in patients with malignant gastroduodenal outlet obstruction and niti-s and wallflex comparison: a multicenter retrospective clinical study." journal of digestive diseases 17.8 (2016): 518-525.Doi http://dx.Doi.Org/10.1111/1751-2980.12377.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 "outcome of self-expandable metallic stent deployment in patients with malignant gastroduodenal outlet obstruction and niti-s and wallflex comparison: a multicenter retrospective clinical study" written by hironari kato, et al.According to the literature, the aim of the study was to evaluate the effectiveness and safety of the deployments of self-expandable metallic stents (sems) for malignant gastric outlet obstruction (goo), and to compare the results of the deployment of two types of uncovered sems: the wallflex enteral duodenal stent (boston scientific) and the niti-s pyloric/duodenal stent (taewoong medical).One-hundred twenty-five (125) patients with malignant goo were included in the study.These patients underwent stent implantation between april 2007 and may 2014.The type of goo was luminal invasion in 24 patients and extraluminal invasion in 101.The etiology of the patients¿ goo included pancreatic cancer (n = 61), biliary tract cancer (n = 26), gastric cancer (n = 25), duodenal cancer (n = 1), and other cancers (n = 12).Seventy-nine (79) patients exhibited a stenosis of the duodenum, and 20 patients had multiple stenosis in the duodenum or in the antrum of the stomach and duodenum.Of the 125 patients included in the study, 46 underwent stenting with the wallflex duodenal stent.Stent deployment was successful in all patients.Thirteen (13) wallflex patients experienced adverse events: 8 events of stent dysfunction, and 8 complications except stent dysfunction.Stent dysfunction included tumor ingrowth (n = 3), tumor overgrowth (n = 1), stent kinking (n = 1), and ¿others¿ (n = 3).Complications except stent dysfunction included early bleeding (n = 2), late bleeding (n = 2), and perforation (n = 1).One niti-s patient also suffered late bleeding.The literature reported that two of the three patients who suffered late bleeding experienced massive bleeding.One of these two patients showed massive bleeding 54 days after stent implantation, and hemostasis was successfully achieved with transcatheter arterial embolization.It is unknown if this patient had been implanted with a wallflex duodenal stent or with the niti-s stent.The other patient had a wallflex duodenal stent implanted and died of massive bleeding 55 days after stent implantation (this event is captured in manufacturer report # 3005099803-2017-00767).The patient who suffered perforation required surgery.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: 6407541
• MDR Text Key: 70026447
• Report Number: 3005099803-2017-00749
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention