MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABIL® BILIARY ENDOPROSTHESIS (GI); CATHETER, BILIARY, DIAGNOSTIC

Catalog Number	VN0806200
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information including gender, initials, age, and weight was requested, however no information was provided.The implant date of the device and patient medical history was requested, however no information was provided.Per the gore® viabil® biliary endoprosthesis instructions for use (ifu): the gore® viabil® biliary endoprosthesis is intended for palliation of malignant strictures in the biliary tree.Additionally, the ifu states the following warning, among others: this product is not intended for removability, and is considered a permanent implant.Specifically, removal of the stent may be impeded by tissue/tumor ingrowth if the stent has transmural drainage holes.In addition, if the stent were placed through a previously placed open cell bare metal stent, removal may be impeded by the structure of the open cell bare metal stent.
Event or Problem Description
It was reported to gore by conmed (rec# (b)(4)) that an ercp procedure was performed using gore® viabil® biliary endoprosthesis (vn0806200).It was reported the proximal end of stent frayed during attempted removal of indwelling stent.Multiple unsuccessful attempts to remove the stent were made, each resulted in further numerous ends of wires protruding in duodenum from ampulla.It was reported they were not unable to clear the debris from the stent or to remove stent.It was reported that a smaller french plastic stent was placed inside remaining stent to facilitate drainage.Reportedly, no additional surgical intervention was required and there was no injury to the patient.It was further reported that the patient is to be monitored on outpatient basis.

• Brand Name: GORE VIABIL® BILIARY ENDOPROSTHESIS (GI)
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8506342
• Report Number: 3003910212-2019-00076
• Device Sequence Number: 1466111
• Product Code: FGE
• UDI-Device Identifier: 00733132615599
• UDI-Public: 00733132615599
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K081184
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/25/2021
• Device Catalogue Number: VN0806200
• Device Lot Number: 17702960
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1