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 Problem Death (1802)

Event Date 11/21/2016

Event Type  Death  

Manufacturer Narrative

The mean age of patients included in the study was 70.5 years (range 63-81 years).The study included 62 patients: 35 males and 27 females.The specific upns and lot numbers were not reported; therefore, the manufacture date and expiration date are unknown.Literature source: rademacher, christoph, et al."self-expanding metal stents for the palliation of malignant gastric outlet obstruction in patients with peritoneal carcinomatosis." world journal of gastroenterology 22.43 (2016): 9554.Doi http://dx.Doi.Org/10.3748/wjg.V22.I43.9554 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 "self-expanding metal stents for the palliation of malignant gastric outlet obstruction in patients with peritoneal carcinomatosis" written by christoph rademacher, et al.According to the literature, the aim of the study was to evaluate the efficacy of self-expanding metal stents (sems) for the palliation of malignant gastric outlet obstruction (goo) in patients with and without peritoneal carcinomatosis (pc).In all cases, patients underwent stent implantation with an uncovered wallflex duodenal stent between january 2008 and april 2014.62 patients were included in the study.The etiology of the patients¿ goo included pancreatic cancer (n = 29), gastric cancer (n = 14), biliary cancer (n = 9), cancer of the ampulla of vater (n = 3), and other causes (n = 7).27 of the patients had pc, and 35 did not.Clinical success was defined as an improvement in obstructive symptoms and discharge from the hospital without needing parenteral nutrition.The article reported that clinical success was achieved in 49 patients and clinical failure of the stent placement was associated with shorter survival.60 of the 62 patients died during follow-up.Those that were effectively palliated exhibited a median survival of 75 days.Those that experienced clinical failure survived a median of 14.5 days.The article did not provide any further information regarding these patients.If any additional information is received, a supplemental report will be filed.

Manufacturer Narrative

Describe event or problem has been updated with additional information received on march 21, 2017.

Event Description

Boston scientific corporation became aware of multiple events through the article "self-expanding metal stents for the palliation of malignant gastric outlet obstruction in patients with peritoneal carcinomatosis" written by christoph rademacher, et al.According to the literature, the aim of the study was to evaluate the efficacy of self-expanding metal stents (sems) for the palliation of malignant gastric outlet obstruction (goo) in patients with and without peritoneal carcinomatosis (pc).In all cases, patients underwent stent implantation with an uncovered wallflex duodenal stent between january 2008 and april 2014.Sixty-two (62) patients were included in the study.The etiology of the patients¿ goo included pancreatic cancer (n = 29), gastric cancer (n = 14), biliary cancer (n = 9), cancer of the ampulla of vater (n = 3), and other causes (n = 7).27 of the patients had pc, and 35 did not.Clinical success was defined as an improvement in obstructive symptoms and discharge from the hospital without needing parenteral nutrition.The article reported that clinical success was achieved in 49 patients and clinical failure of the stent placement was associated with shorter survival.60 of the 62 patients died during follow-up.Those that were effectively palliated exhibited a median survival of 75 days.Those that experienced clinical failure survived a median of 14.5 days.***additional information received on march 21, 2017: according to the corresponding author, none of the deaths mentioned in the article were related to the stent.All patient deaths were due to tumor progression.

• 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: 6411816
• MDR Text Key: 70170343
• Report Number: 3005099803-2017-00768
• 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,Followup
• 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?: No
• 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: 03/16/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/13/2017
• 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