MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® ENDOPROSTHESIS; SYSTEM, ENDO GRAFT, ARTERIOVENOUS DIALYSIS ACCESS CIRCUIT STENOSIS TREATMENT

Catalog Number	VBCR111002A
Medical Device Problem Codes	Activation Failure (3270); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The following was reported to gore: on an unknown date, the patient underwent a procedure for a av fistula in the upper arm using a gore® viabahn® endoprosthesis (viabahn device).It was reported that the physician was unable to deploy the viabahn device inside the body as the deployment line would not detach from the stent.
Additional Manufacturer Narrative
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
The following was reported to gore: on (b)(6) 2024, the patient underwent a revision procedure for an av fistula in the upper arm using a gore® viabahn® endoprosthesis (viabahn device).It was reported that the physician was able to reach the target treatment area using a cordis brite tip sheath introducer (unknown size) and a.035" terumo glide wire.There was no resistance while advancing the viabahn device.When pulling on the deployment line, the deployment line did not unravel all the way before partial device expansion.There was some resistance when pulling the deployment line.The deployment line would not untie to allow the device to completely expand.The viabahn device was pulled out over the guidewire and the sheath was removed from the patient.The procedure was completed with a 10x10 viabahn device.It was reported there was no impact to the patient.
Additional Manufacturer Narrative
Manufacturing records were reviewed, and the device met all pre-release specifications.The delivery system was returned to gore for evaluation.Evaluation of the returned product indicates a stuck deployment line after partial expansion of the vsx device.The vsx device endoprosthesis as returned was partially deployed and expanded distally, while the proximal end was still constrained on the delivery system.Resistance was felt within the catheter when attempting deployment of the returned vsx device during evaluation.Deployment of the vsx device was able to continue with resistance when pulling the deployment line at the endoprosthesis, demonstrating that the deployment mechanism itself was not stuck.Procedural and benchtop deployment of the device can be impacted by different factors including but not limited to zipper integrity, delivery system support or stiffness, or presence of dried fluid on the device.The investigation could not confirm the cause of the reported hazardous situation nor assign a primary device failure mode.The root cause of the stuck vsx device deployment line as reported could not be established.Further information regarding this event was requested by gore, but no further information has been reported, therefore this investigation is considered complete.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS
• Common Device Name: SYSTEM, ENDO GRAFT, ARTERIOVENOUS DIALYSIS ACCESS CIRCUIT STENOSIS TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: vanessa rodriguez ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 19218273
• Report Number: 2017233-2024-04886
• Device Sequence Number: 15195868
• Product Code: PFV
• UDI-Device Identifier: 00733132645886
• UDI-Public: 00733132645886
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P130006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2024

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: 06/15/2026
• Device Catalogue Number: VBCR111002A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2024
• Supplement Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 04/30/2024
• Supplement Report FDA Received Date: 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2023
• 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
• Patient Sex: Unknown