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

Model Number M00555870

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Anemia (1706); Death (1802); Perforation (2001); Peritonitis (2252)

Event Date 09/20/2018

Event Type  Death  

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 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
• Type of Device: STENT,METALLIC,EXPANDABLE,DUODENAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 8300809
• MDR Text Key: 134855698
• Report Number: 3005099803-2019-00452
• Device Sequence Number: 1
• Product Code: MUM
• UDI-Device Identifier: 08714729902508
• UDI-Public: 08714729902508
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: SIMILAR
• 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: 02/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00555870
• Device Catalogue Number: 5587
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2019
• 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): Death; Required Intervention
• Patient Age: 40 YR