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 Migration or Expulsion of Device (1395)

Patient Problems Inflammation (1932); Perforation (2001); Obstruction/Occlusion (2422); No Code Available (3191)

Event Date 12/18/2015

Event Type  Injury  

Manufacturer Narrative

The median age range of patients was 71 (35-94 years).Of the 312 patients, 177 (57%) were male and 135 (43%) were female.The specific upns and lot numbers were not reported; therefore, the manufacture dates and expiration dates are unknown.(b)(4).Journal article: shuji saito, et al."a prospective multicenter study on self-expandable metallic stents as a bridge to surgery for malignant colorectal obstruction in japan: efficacy and safety in 312 patients¿ springer science + business media new york 2015; 30:3976-3986.Doi http://dx.Doi/org/10.1007/s00464-015-4709-5.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 ¿a prospective multicenter study on self-expandable metallic stents as a bridge to surgery for malignant colorectal obstruction in japan: efficacy and safety in 312 patients¿ written by shuji saito, et al.According to the literature, the aim of this study was to estimate the safety and feasibility of self-expandable metallic stents (sems) placement as a bridge to surgery (bts) for malignant colorectal obstruction.An observation, single-arm, multicenter clinical trial was conducted from march 2012 to october 2013.Each patient was treated with an uncovered wallflex enteral colonic stent.The study included 518 patients; 5 patients were excluded due to loose stenosis identified by colonoscopy (n=3), adhesive small bowel obstruction (n=1) and placement of another type of sems (n=1).The remaining 513 patients were the pre-protocol cohort; the intention of treatment was a bts in 312 patients (61%) and palliative in 201 patients.Of the 312 patients, 296 (95%) presented with acute colonic obstructive symptoms and the remaining 16 patients did not have any stricture-related symptoms.Colorectal cancer (crc) was reported in 98% of the patients and the remaining 5 either had locally recurrent crc (n=2), extra colonic cancer (n=1), or benign lesions pathologically proven after surgery (n=2).The tumor was located in the left colon in 76% of the patients, in the rectum in 4% of patients, and proximal to the splenic flexure in 21% of patients.The article reported that 5 patients suffered from perforation, which required emergency surgery.One patient presented with abdominal emergency 2 days after stent placement.This patient underwent an acute laparotomy and a blowout perforation in the cecum was identified.One patient suffered from a tumor perforation and underwent acute surgery 2 days post-stent placement.One patient suffered a perforation of the appendix with primary tumor invasion and underwent acute surgery 2 days post-stent placement.Two patients suffered perforation from the edge of the stent flare and underwent emergency surgery at 5 and 19 days post-stent placement, respectively.Silent perforation, which the article defined as intraoperative exposure of the stent in the abdominal cavity without preoperative symptoms, was observed in four patients.Stent migration occurred in 4 patients, 3 patients experienced persistent colonic obstruction, one patient developed acute appendicitis, and one patient suffered from stool impaction.The patient that suffered stool impaction underwent endoscopic cleaning the day after stent implantation.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: 6410049
• MDR Text Key: 70112620
• Report Number: 3005099803-2017-00791
• 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: 03/16/2017
• 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