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

Catalog Number	VSWVN1008
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	11/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to gore by conmed (cen-65010) that during a repeat endoscopic retrograde cholangiopancreatography (ercp) procedure, due to increased lfts using the gore® viabil® short wire biliary endoprosthesis, reportedly, the stent was occluded.The plan was to perform a stent exchange, it was reported that parts of the stent disintegrated during removal, and small pieces were removed.There was reportedly a 30 minute delay of procedure.Another gore® viabil® short wire biliary endoprosthesis was used to complete the procedure.The patient status is unknown at this time.The device is available for return.
Additional Manufacturer Narrative
A1: no patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.A2 - a4: age was requested, but not provided.H3: it was stated the device is available for return, however, the device has yet to be returned.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
Multiple attempts were made to obtain additional information, however no response from the complainant was received.No further details are available at this time.The gore® viabil® short wire biliary endoprosthesis instructions for use (ifu) warns: the complications associated with the use of the gore® viabil® biliary endoprosthesis may include complications associated with other biliary endoprostheses, including but not limited to: endoprosthesis misplacement, endoprosthesis migration, endoprosthesis fracture, obstruction of branch ducts, bleeding due to vascular erosion, and endoprosthesis occlusion due to biofilm/sludge formation, extrinsic compression or tumor overgrowth at the endoprosthesis ends.Complications may also include those often associated with any endoscopic procedure performed on the biliary tract.These complications include: infection, bleeding, duct perforation, hematoma, hemobilia, cholangitis, pancreatitis, fever, trauma to ductal system or duodenum, and death.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 an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".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.

• 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: 18332050
• Report Number: 3003910212-2023-01532
• Device Sequence Number: 20518360
• Product Code: FGE
• UDI-Device Identifier: 00733132638871
• UDI-Public: 00733132638871
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K014215
• 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: Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2024

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: 04/16/2026
• Device Catalogue Number: VSWVN1008
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2023
• Supplement Date Received by Manufacturer: 11/21/2023
• Initial Report FDA Received Date: 12/14/2023
• Supplement Report FDA Received Date: 01/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female