MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX DUODENAL SOFT STENT SYSTEM WITH ANCHOR LOCK DELIVERY SYSTEM; STENT,METALLIC,EXPANDABLE,DUODENAL

Model Number	M00555870
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Anemia (1706); Death (1802); Perforation (2001); Peritonitis (2252)
Date of Event	09/20/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number.Therefore, the manufacture and expiration dates are unknown.(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation on january 10, 2019 that a wallflex duodenal soft uncovered stent was implanted in the duodenum to treat a stenosis due to pancreatic cancer during a stent placement procedure performed on (b)(6) 2018.According to the complainant, on (b)(6) 2018, the stent was successfully implanted; the proximal side of the stent was in the stomach and the distal end did not reach the papilla.A computed tomography (ct) scan was performed and showed the entire stenosis was covered, and no problem was observed.According to the complainant, the patient could eat a 5 minute meal porridge several days after stent placement.However, it was reported that ascites puncture was necessary to perform every day.On (b)(6) 2018, anemia developed and the patient received blood transfusion.On (b)(6) 2018, patient's hemoglobin count improved and the anemia stopped.On (b)(6) 2018, patient's hemoglobin count decreased and the anemia redeveloped.Symptoms of abdominal pain were also noticed but observation using an endoscope could not be performed due to the patient condition.On (b)(6) 2018, the patient passed away.On january 10, 2019 , an autopsy report was reported and it was found that the stomach was perforated with the proximal stump of the duodenal stent, and the contents inside the stomach leaked into the abdominal cavity.The cause of death was shock due to peritonitis.Per the physician, the patient's condition was not really good, and even if the duodenal stent was not inserted, there will still be a high possibility that the patient will die.

• Brand Name: WALLFLEX DUODENAL SOFT STENT SYSTEM WITH ANCHOR LOCK DELIVERY SYSTEM
• Common Device Name: STENT,METALLIC,EXPANDABLE,DUODENAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8300809
• Report Number: 3005099803-2019-00452
• Device Sequence Number: 1064186
• Product Code: MUM
• UDI-Device Identifier: 08714729902508
• UDI-Public: 08714729902508
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: SIMILAR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/04/2019

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
• Operator of Device: Health Professional
• Device Model Number: M00555870
• Device Catalogue Number: 5587
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2019
• Initial Report FDA Received Date: 02/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Age: 40 YR