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

Catalog Number	VSWVH1006
Medical Device Problem Codes	Fracture (1260); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Unspecified Hepatic or Biliary Problem (4493)
Date of Event	11/17/2023
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.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.
Event or Problem Description
It was reported to gore by conmed ((b)(6)) that during an unknown procedure using the gore® viabil® short wire biliary endoprosthesis, the stent broke into pieces and all pieces were eventually removed.The device is not available for return.There is no indication of patient impact.It was further reported this case was a planned removal.The device was placed in the common bile duct on (b)(6), 2023.There was no out of the ordinary manipulation of the endoscope or catheter during the removal.A duodenoscope was used and the initial attempt was with a snare, which is when the stent fractured.Multiple attempts with the snare and raptor grasper were made.The device was discarded after the case.

• 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: 18440598
• Report Number: 3003910212-2024-01535
• Device Sequence Number: 7566814
• Product Code: FGE
• UDI-Device Identifier: 00733132638796
• UDI-Public: 00733132638796
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K170740
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/03/2024

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: 10/01/2025
• Device Catalogue Number: VSWVH1006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2024
• Initial Report FDA Received Date: 01/03/2024
• Date Device Manufactured: 10/03/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 19 YR
• Patient Sex: Female
• Patient Weight: 72 KG