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); Migration or Expulsion of Device (1395); Appropriate Term/Code Not Available (3191); Activation Failure (3270)

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Pain (1994)

Event Date 11/21/2016

Event Type  Injury  

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.(b)(4).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.Approx 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).Approx 27 of the patients had pc, and 35 did not.In this study, technical success was defined as successful stent deployment and expansion.In one case, technical failure occurred due to insufficient expansion of the stent.Ten patients treated successfully with respect to clinical outcome required endoscopic reintervention.Two of the patients experienced early stent failure at 14 days and 17 days respectively, and eight patients experienced late stent failure at a median of 130.5 days.The nature of the stent failures was not described.These 10 patients were successfully palliated by another endoscopic intervention, which included insertion of another sems in six patients, argon plasma coagulation treatment in two patients, and mechanical stent recanalization in two patients.Three patients required more than one reintervention.Three patients experienced major complications, including gastrointestinal bleeding in two patients and severe pain related to hematoma of the stomach wall in one patient.The cases of hemorrhage were due to diffuse bleeding from the tumor.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

(b)(4).

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.The 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).The 27 of the patients had pc, and 35 did not.In this study, technical success was defined as successful stent deployment and expansion.In one case, technical failure occurred due to insufficient expansion of the stent.Ten patients treated successfully with respect to clinical outcome required endoscopic reintervention.Two of the patients experienced early stent failure at 14 days and 17 days respectively, and eight patients experienced late stent failure at a median of 130.5 days.The nature of the stent failures was not described.These 10 patients were successfully palliated by another endoscopic intervention, which included insertion of another sems in six patients, argon plasma coagulation treatment in two patients, and mechanical stent recanalization in two patients.Three patients required more than one reintervention.Three patients experienced major complications, including gastrointestinal bleeding in two patients and severe pain related to hematoma of the stomach wall in one patient.The cases of hemorrhage were due to diffuse bleeding from the tumor.Additional information received on march 21, 2017: according to the corresponding author, the early stent failures mentioned in the article included one case of stent migration and one case of inadequate stent expansion, possibly due to a very tight stenosis.The eight cases of late stent failure mentioned in the article were all stent occlusions due to ingrowth of the tumor or hyperplastic duodenal mucosa.

• 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: 6411866
• MDR Text Key: 70170367
• Report Number: 3005099803-2017-00771
• 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?: 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: 03/16/2017
• 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): Required Intervention