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 Problems Death (1802); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Necrosis (1971)

Event Date 05/16/2014

Event Type  Death  

Manufacturer Narrative

The specific upn and lot number was not reported; therefore, the manufacture date and expiration date is unknown.Literature sources: 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.Matsumoto, kazuya, et al."late complications of self-expandable metallic stent placement for malignant gastric outlet obstruction." internal medicine 53.24 (2014): 2773-2775.Doi http://dx.Doi.Org/10.2169/internalmedicine.53.2936.The device has not been received for analysis; therefore a failure analysis of the complaint device 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 an adverse patient event through the articles "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., and "late complications of self-expandable metallic stent placement for malignant gastric outlet obstruction" written by kazuya matsumoto, et al.According to the articles, the patient had presented to a clinic complaining of vomiting and upper abdominal discomfort.After an initial computed tomography (ct) examination, the patient was admitted to the hospital.An abdominal ct on day 1 after admission showed a tumor in the pancreatic head with invasion into the superior mesenteric artery, stenosis of the third part of the duodenum, and expansion of the oral side of the narrowed segment.Blood testing was conducted and endoscopic ultrasound-guided fine needle aspiration (eus fna) biopsy of the pancreatic tumor in the second third of the duodenum was performed.The patient was subsequently diagnosed with pancreatic cancer [t4, n0, m1] stage iv.The patient underwent stenting with a wallflex enteral duodenal stent to treat malignant gastric outlet obstruction 12 days after admission to the hospital.After stent placement, the patient resumed an oral diet and began chemotherapy (gem 1,000 mg/m² weekly, 2q3w and s-1 80mg/body/day, d1-14, q3w).On day 55, the patient presented with cold sweats, hypotension, and hematemesis.Ct imaging was performed and showed high-density areas from the stomach to the rectum.Blood-related contents were suspected and air was observed outside of the gastrointestinal tract around the stent in the third part of the duodenum.The air appeared to be localized to the pancreatic cancer site.The physician suspected an aerobic infection as no widespread free air was noted in the abdominal cavity or retroperitoneum.Esophagogastroduodenoscopy revealed a large quantity of clotted blood from the stomach to the duodenum; however, no active bleeding was noted on observation.The origin of the bleeding was diagnosed to be the last third of the duodenum.Upon request of the patient¿s family, the patient was transitioned to palliative care.The patient died 10 hours after the onset of hematemesis.An autopsy noted that the region of the duodenum where the stent had been placed had turned black, indicating tumor necrosis.It was also noted that relatively thick arteries had accumulated in the tumor region.These had ruptured, causing bleeding.Gram-positive bacteria and cocci were identified within the necrotic material.The article concluded that tumor necrosis had developed as a result of various factors, including stent placement.The patient¿s cause of death was determined to be bleeding due to the disruption of elastic arteries in the necrotic portion of the pancreatic lesion as a result of stent placement.

• 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: 6407529
• MDR Text Key: 70025139
• Report Number: 3005099803-2017-00767
• 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?: 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: 03/15/2017
• 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): Death
• Patient Age: 68 YR