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); Migration or Expulsion of Device (1395); Activation Failure (3270)

Patient Problems Aspiration/Inhalation (1725); Hemorrhage/Bleeding (1888); Hypoxia (1918); Inflammation (1932); Perforation (2001)

Event Date 09/12/2016

Event Type  Injury  

Manufacturer Narrative

The mean age of patients included in the study was 69.7 years (range 63-81 years).The study included 100 patients: 43 males and 57 females.The lot numbers and upns, as reported by the corresponding author, along with their corresponding device manufacture and expiration dates are summarized in the attached excel spreadsheet.(b)(4).Literature source: grunwald, douglas, et al."the location of obstruction predicts stent occlusion in malignant gastric outlet obstruction." therapeutic advances in gastroenterology 9.6 (2016): 815-822.Doi http://dx.Doi.Org/10.1177/1756283x16667893.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 ¿the location of obstruction predicts stent occlusion in malignant gastric outlet obstruction¿ written by douglas grunwald, et al.According to the literature, the aim of the study was to determine whether the location of the malignant obstruction and stent angulation are associated with stent occlusion requiring reintervention.The study took place between 2006 and 2015, and included 100 patients.The etiology of patients¿ obstructions included gastric cancer (n = 15), duodenal cancer (n = 8), pancreatic cancer (n = 44), biliary cancer (n = 14), and other cancer types (n = 19).All patients were treated with wallflex enteral duodenal stents.The article reported that, out of 100 procedures, there were 12 procedure-related complications: gastrointestinal bleeding in 4 patients, duodenal perforation in 2 patients, aspiration in 3 patients, post- procedure pancreatitis in 2 patients, and boerhaave¿s syndrome in 1 patient.In two cases, these complications led to periprocedural death (captured by manufacturer report # 3005099803-2017-00746).It was noted in the article that these complications were directly related to the stent placement and were not due to other circumstances.According to the corresponding author, in one patient who suffered a duodenal perforation, two wallflex enteral duodenal stents had been placed.Prior to stent implantation, this patient had presented with a severe distension of the stomach with food present, which was consistent with gastric outlet obstruction.The patient¿s pylorus was patent and there was a very tight malignant intrinsic stricture at the level of the duodenal bulb.The scope was unable to traverse this lesion.A wire and a balloon catheter were advanced through the duodenal stricture.Contrast was injected and it was noted that there were two areas of narrowing, one at the level of the duodenal bulb and other at the second portion of the duodenum.Then, two 120mm by 22mm wallflex enteral duodenal stents were placed successfully (one immediately distal to the other) across the strictures at the duodenal bulb and the second portion of duodenum.After the duodenal stents were placed, a naso-gastric tube was placed in order to get a better decompression of the stomach.In the other patient who suffered a duodenal perforation, a stent was implanted on (b)(6) 2006; however, due to tumor ingrowth, a second stent was implanted across the distal stent blockage of the first stent on (b)(6) 2006.Both stent were implanted in the duodenum.The duodenal perforation occurred after the placement of the second stent.The corresponding author reported that one patient who experienced aspiration also suffered from hypoxia.The patient who suffered boerhaave¿s syndrome began wretching in recovery the day after the wallflex enteral duodenal stent was placed in the duodenum.An x-ray revealed free air and a repeat esophagogastroduodenoscopy (egd) showed an esophageal perforation.The patient later had a wallflex esophageal stent placed after they developed boerhaave¿s syndrome.The article also reported that 21 patients developed stent occlusion.The causes of stent occlusion included: tumor ingrowth in 12 patients, stent kinking in 3 patients, foodstuffs in 2 patients, migration in 2 patients, distal stricture in 1 patient and nonexpansion in 1 patient.Most early occlusions were due to technical failures of stent placement (kinking, migration), while almost all later obstructions were related to tumor ingrowth.The article and corresponding author 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: 6413052
• MDR Text Key: 70250911
• Report Number: 3005099803-2017-00748
• Device Sequence Number: 1
• Product Code: MUM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• 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: 03/17/2017
• 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