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 Codes	Break (1069); Failure to Advance (2524); Separation Failure (2547); Malposition of Device (2616)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	07/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section h6 updated to reflect completion of investigation.Code d16 was removed and code d15 was added.The delivery system was returned to gore for evaluation.The alleged inability to advance the viabahn device to the target location and inability to withdraw the viabahn device could not be directly confirmed by evaluation of the returned device nor the images/videos provided.Though the images provided and the condition of the device as returned for evaluation are consistent with the allegations.The reported viabahn device deployment line breakage was confirmed by returned device evaluation.The root causes of the advancement difficulty, inability to withdraw, and deployment line breakage during attempted deployment could not be established with the information available including evaluation of the returned device and the images/videos provided.Further information regarding this event was requested by gore, but no further information has been reported, therefore this investigation is considered complete.
Additional Manufacturer Narrative
H6 code c19: a review of the manufacturing records indicated the device met pre-release specifications.Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 cfr 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 a in-stent restenosis of a bare metal stent (manufacture unknown) which was placed in the left common iliac (lci) extending to the external iliac.A gore® viabahn® endoprosthesis with heparin bioactive surface (viabahn device) was implanted in the superficial femoral artery (sfa) with left foot access.The viabahn device was intended to be implanted in the left common iliac artery.A 6-7fr terumo glidesheath slender® hydrophilic coated introducer sheath was used along with a.018 asahi gladius® guidewire.The target treatment area was not pre-dilated and the physician went in with intravascular ultrasound (ivus).Just below the knee or at the knee appeared wide open, no tortuous anatomy or calcification.Once the sfa was reached the physician could no longer advance or retract the viabahn device due to an unknown blockage, the physician made a decision to deploy the viabahn device in the sfa by pulling on the deployment line with no resistance, however, the deployment line broke and the physician was unsure if viabahn device deployed or remained constrained since a significant amount of deployment line was pulled, there was no distal expansion of the viabahn device.It took a couple of hours to get the viabahn endoprosthesis to dislodge from the delivery system.Going from top and bottom an 0.014" guidewire (top access from right groin) was placed between the delivery catheter and the endoprosthesis.While having wire access, a cardiac balloon was inserted between the delivery catheter and endoprosthesis, in attempt to open it up.There was some resistance but they placed some pressure on the delivery system to get the delivery marker away from the endoprosthesis when they found an opening, a 3x2 balloon was used and stared inflating the balloon in increments and they were able to get the endoprosthesis open enough to withdraw the delivery catheter with the olive.An unknown material from the patient was attached to the delivery catheter when withdrawn.The 7x10 viabahn device is now implanted in the mid left sfa and was post dilated it.The procedure was completed going through the right groin (new cut) using the same guidewire with a new sheath and three additional viabahn devices were used (7x10, 8x59, and a 7x79) to line the bare metal stents (in the lci) to the left common femoral.No major branches were covered, avoiding the hunters canal.A dissection was noticed near where the 7x10 viabahn device was implanted, the field sales associated suggested treatment for the dissection, however, no treatment was given to correct the dissection.It was reported that a large amount of force was used advancing.No deployment line fragments were left in the patient.

• 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: 22785929
• Report Number: 2017233-2025-06501
• Device Sequence Number: 15919986
• Product Code: NIP
• UDI-Device Identifier: 00733132623778
• UDI-Public: (01)00733132623778(17)280204
• Combination Product (Y/N): Y
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P040037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 11/12/2025

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: 08/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/12/2025
• Supplement Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2025
• 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
• Patient Age: 64 YR
• Patient Sex: Unknown