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

Catalog Number VN0806200

Device Problem Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/07/2019

Event Type  malfunction  

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 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)
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MPD APC B/P; p.o. box 1408; elkton MD 21922 1408
• Manufacturer Contact: cheryl hawke ; 1500 n. 4th street; 9285263030
• MDR Report Key: 8506342
• MDR Text Key: 145639716
• Report Number: 3003910212-2019-00076
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 00733132615599
• UDI-Public: 00733132615599
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081184
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/25/2021
• Device Catalogue Number: VN0806200
• Device Lot Number: 17702960
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2018
• 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