MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE; STENT, SUPERFICIAL FEMORAL ARTERY

Catalog Number	VBJR071002A
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.H6 code c19: a review of the manufacturing records indicated the device met pre-release specifications.H6 code c21: device is being investigated by gore's engineers, results are pending.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 a transcatheter aortic valve replacement (tavr) procedure, during which bleeding was observed in the iliac artery.To address this complication, the physician intended to implant a 7x10 gore® viabahn® endoprosthesis with heparin bioactive surface (viabahn device) in the iliac artery.During the intervention, a 7fr terumo destination¿ guiding sheath and a 0.014" balance middleweight universal (bmw) guidewire were utilized to access the target treatment area.However, when the physician attempted to deploy the viabahn device by pulling the deployment line, it failed to deploy.The device was subsequently withdrawn, and the procedure was completed using a 7x29 gore®viabahn®vbx balloon expandable endoprosthesis.The physician was unable to determine the cause of the deployment failure.The field sales associate advised that an 0.018" guidewire would have been more appropriate than the 0.014" guidewire used.
Event or Problem Description
On (b)(6) 2025, the patient underwent a transcatheter aortic valve replacement (tavr) procedure, during which bleeding was observed in the iliac artery.To address this complication, the physician intended to implant a 7 x 10 gore® viabahn® endoprosthesis with heparin bioactive surface (viabahn device) in the iliac artery.During the intervention, a 7fr terumo destination¿ guiding sheath and a 0.014" balance middleweight universal (bmw) guidewire were utilized to access advance the viabahn device target treatment area with no resistance.However, when the physician attempted to deploy the viabahn device by pulling the deployment line, it failed to deploy.The deployment line was not pulled all the way.The constrained device was subsequently withdrawn through the sheath, and the procedure was completed using a 7 x 29 gore® viabahn® vbx balloon expandable endoprosthesis.The physician was unable to determine the cause of the deployment failure.The field sales associate advised that an 0.018" guidewire would have been more appropriate than the 0.014" guidewire used.Additionally, the physician suspects the initial bleeding which was observed in the iliac artery was due to sheath and vessel interaction.
Additional Manufacturer Narrative
B5: updated event description.Section h6 updated to reflect completion of investigation.Manufacturing records were reviewed, and the device met all pre-release specifications.The device was returned to gore for evaluation.Evaluation of the returned product indicates the condition of the device was consistent with the product listed within the complaint and a partially deployed device.Engineering evaluation of the device could not confirm the reported primary failure mode, deployment line stuck, as deployment could continue via the knob.Replication of this failure mode is not always possible because of differences between conditions seen in vivo (i.E., patient anatomy, procedural conditions) and those seen in the laboratory.Procedural 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 or within the catheter dual lumen.The use of a 0.14" guidewire is compatible with the device configuration used per the instructions for use (ifu).The root cause of the failure mode could not be established with the available information, including device evaluation.Engineer evaluation of the returned device indicated damage, some zipper material appeared bunched near the proximal end of the endo.The damage had no impact on the ability to deploy via the knob and therefore no impact on the reported failure mode.The root cause of the damage could not be established within the engineering evaluation, but it is consistent with damage resulting from an unknown device interaction during insertion/withdrawal, or manipulation of the device either during or after the procedure.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: STENT, SUPERFICIAL FEMORAL ARTERY
• 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: 23871985
• Report Number: 2017233-2025-06991
• Device Sequence Number: 5330022
• Product Code: NIP
• UDI-Device Identifier: 00733132623778
• UDI-Public: (01)00733132623778(17)270509
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P040037
• 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): 02/06/2026

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 Catalogue Number: VBJR071002A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2024
• 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: Male
• Patient Weight: 76 KG