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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MOD M00565010; STENT,METALLIC,EXPANDABLE,DUODENAL

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BOSTON SCIENTIFIC - GALWAY WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MOD M00565010; STENT,METALLIC,EXPANDABLE,DUODENAL Back to Search Results
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.
 
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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 Key6407529
MDR Text Key70025139
Report Number3005099803-2017-00767
Device Sequence Number1
Product Code MUM
Combination Product (y/n)N
PMA/PMN Number
K062750
Number of Events Reported1
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 NumberUNK476
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/20/2017
Initial Date FDA Received03/15/2017
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 Number1
Patient Outcome(s) Death;
Patient Age68 YR
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