MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE; SYSTEM, ENDOVASCULAR GRAFT, ARTERIOVENOUS (AV) DIALYSIS ACCESS CIRCUIT STENOSIS

Catalog Number	VBJR080502A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	10/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6 code c19: a review of the manufacturing records indicated the lot met pre-release manufacturing specifications.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
On (b)(6) 2025, the patient underwent treatment for superficial femoral artery (sfa) fistula during which two gore® viabahn® endoprostheses with heparin bioactive surface (viabahn devices) were implanted in the superficial femoral artery (sfa).The physician accessed the target treatment area via groin access using a terumo 7fr introducer sheath and a terumo 0.014" runthrough® ns extra floppy coronary guidewire.The first viabahn device was successfully implanted distally in the sfa.Subsequently, a second viabahn device (lsn (b)(6)) was deployed proximally.However, during withdrawal of the viabahn delivery system, the distal tip of the system caught the edge of the proximal viabahn endoprosthesis, causing it to be dragged backward toward the sheath and resulting in coverage of the profunda artery.There were no attempts made to place the viabahn device back into place in the proximal sfa before removing the viabahn device surgically.The physician suspects that the distal edge of the viabahn device did not fully expand and lacked adequate wall apposition.Intravascular ultrasound (ivus) was utilized during the procedure.The patient is currently doing well following the procedure.
Additional Manufacturer Narrative
C1: added name and manufacturer.Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.E4: initial reporter also sent report to fda.H10: added related report number provided from the voluntary mdr.Section h6 updated to reflect completion of investigation.A review of manufacturing records verified that the lot involved in this complaint met all pre-release specifications.The device was discarded at the treating facility and was, therefore, not available for analysis.No clinical images enabling direct assessment of product performance were returned for evaluation.The instructions for use provide specific instructions and warns against the application of force to the delivery system in the event that the distal tip becomes caught on the endoprosthesis.The root cause of the reported device migration is consistent with the potential use error of continuing to pull on the deployment system during withdrawal after resistance is encountered.Based on the information provided, the decision to remove the endoprosthesis was made based on procedural considerations.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 WITH HEPARIN BIOACTIVE SURFACE
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, ARTERIOVENOUS (AV) DIALYSIS ACCESS CIRCUIT STENOSIS
• 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: 23481565
• Report Number: 2017233-2025-06792
• Device Sequence Number: 18724608
• Product Code: PFV
• UDI-Device Identifier: 00733132623815
• UDI-Public: (01)00733132623815(17)280622
• Combination Product (Y/N): Y
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P130006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 02/06/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: VBJR080502A
• 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: 10/14/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/24/2025
• 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: Other; Hospitalization; Required Intervention
• Patient Sex: Male