MAUDE Adverse Event Report: W. L. GORE ASSOCIATES, INC. GORE VIABIL BILIARY ENDOPROSTHESIS; CATHETER, BILIARY, DIAGNOSTIC

Model Number	VN0806200
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/13/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Stent malfunction during procedure.Bent at the distal tip upon deployment.Had to place another stent.Procedure in detail: therapeutic gastroscope was advanced from esophagus to the stomach.Fluid was suctioned out from stomach.The gastroscope was advanced from the pylorus to the bulb, where post bulbar duodenal stricture was noted.We could not advance the gastroscope beyond the stricture.A retrieval balloon with preloaded guidewire was advanced through the stricture.A nasoduodenal tube was advanced over the guidewire with a distal end in the proximal jejunum.The gastroscope was removed and a linear echoendoscope was advanced to the stomach.Contrast was injected to assess the placement.Large amount of water mixed with methylene blue was used to distend the small bowel.1 mg of iv glucagon was given to decrease small bowel motility.There was significant amount of ascites noted around the liver and small bowel.We could not find a safe window to perform an eus gastrojejunostomy as the lumen of the small bowel was at least ~20 mm away from the gastric wall.The plan for gastrojejunostomy was aborted.The linear eus scope was removed along with the nasoduodenal tube.The therapeutic gastroscope was reintroduced and a guidewire was advanced through the duodenal stricture.A cook evolution uncovered duodenal 22 mm x 6 cm metal stent was placed over the guidewire.The proximal end of the stent was just proximal to the pylorus.The eus scope was reintroduced into the stomach.A site for hepaticogastrostomy was found within the left hepatic lobe by using linear echoendoscope.A19g olympus needle was used to access the left hepatic ducts and the guidewire advanced through the biliary tree, through the transpapillary stent, into the duodenum.Cholangiogram showed evidence of irregular narrowing within the stent.The tract was created with a needle knife and then dilated with 4mm dilation balloon.An 8 mm x 6 cm fully covered gore viabil stent was placed for hepaticogastrostomy.The stent appeared in good position endoscopically and fluoroscopically.A 7 fr x 25 cm zimmon plastic stent was placed through the viabil with the distal end in the 3rd portion of the duodenum and the proximal end in the stomach lumen.The echoendoscope was then completely withdrawn, insufflated air was aspirated, and the patient was allowed to recover.No immediate post procedure complications were observed.

• Brand Name: GORE VIABIL BILIARY ENDOPROSTHESIS
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): W. L. GORE ASSOCIATES, INC.; 301 airport rd.; elkton MD 21921
• MDR Report Key: 9081542
• Report Number: 9081542
• Device Sequence Number: 11416910
• Product Code: FGE
• UDI-Device Identifier: 00733132615599
• UDI-Public: (01)00733132615599(17)211115
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/26/2019
• Report Date (Section F): 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: VN0806200
• Device Catalogue Number: VN0806200
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/18/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 63
• Date Report Sent to FDA: 08/26/2019