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

Model Number	VSWVN1008
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Codes	Stenosis (2263); Swelling/ Edema (4577)
Date of Event	11/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the gore® viabil® biliary endoprosthesis instructions for use (ifu), 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 ((b)(4)) that during an endoscopic retrograde cholangiopancreatography (ercp) procedure using the gore® viabil® biliary endoprosthesis, dr.(b)(6) had placed a viabil®.He proceeded to remove the viabil® (off label) and it began to unravel.It was lodged into the bile duct.The sales rep spoke with (b)(6) who is the lead admin at u of c and also spoke with dr.(b)(6) on the phone offering help.A month later dr.(b)(6) was able to remove the viabil® from the patient with no other issues.There was no impact to the patient.A histology kit has been ordered for the return of the explanted device.
Additional Manufacturer Narrative
According to the gore® viabil® biliary endoprosthesis instructions for use (ifu), 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.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
Additional Manufacturer Narrative
H6 investigation conclusions: corrected to d15 cause not established.

• Brand Name: GORE® VIABIL® SHORT WIRE BILIARY ENDOPROSTHESIS
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MPD APC B/P; p.o. box 1408; elkton MD 21922 1408
• Manufacturer Contact: megan reigh ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13591856
• Report Number: 3003910212-2022-01335
• Device Sequence Number: 14543783
• Product Code: FGE
• UDI-Device Identifier: 00733132638871
• UDI-Public: 00733132638871
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K014215
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/12/2023

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: 07/21/2023
• Device Model Number: VSWVN1008
• Device Catalogue Number: VSWVN1008
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2022
• Supplement Date Received by Manufacturer: 02/09/2022; 02/09/2022
• Initial Report FDA Received Date: 02/24/2022
• Supplement Report FDA Received Date: 06/07/2022; 04/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown