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

Catalog Number	VBHR070502A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a patient with bilateral lower-limb bypass grafts, underwent left leg bypass revision (brand of grafts and date of initial implant unknown).It was reported the patient did not take anticoagulant medication for at least 12 days.On (b)(6) 2025, the patient presented with lower limb threatening ischemia of unknown duration.It was noted there was thrombosis in the left femoral-tibial bypass artery bypass graft, and severe stenosis in the left external iliac artery.The decision was made to use a 7 mm x 5 cm gore® viabahn® endoprosthesis with heparin bioactive surface (viabahn device) in the severely stenosed left external iliac artery.It was reported, the lesion in the external iliac artery was pre-dilated with a 6 mm x 60 mm armada balloon.The physician accessed the patient using a 10 f unknown brand introducer sheath over an.035" terumo advantage guide wire (180 cm) to the target treatment site.Reportedly, the endoprosthesis deployed.After withdrawal of the delivery system catheter, it was noticed the distal section of the catheter was retained inside the patient.The case was extended by approximately 30 - 40 minutes and additional heparin was utilized.The broken catheter was successfully removed using a snaring device.It is unknown what caused the delivery catheter to break.Additionally, during the procedure embolectomy was performed on the left anterior tibial and popliteal artery, and the iliofemoral artery.Balloon angioplasty was done at the proximal arterial anastomosis at the common femoral artery.At the end of the procedure the patient had a palpable pulse at the dorsalis pedis location.It was reported the patient tolerated the procedure.
Additional Manufacturer Narrative
B15 - used for provided photo.A review of manufacturing records verified that the lot involved in this complaint met all pre-release specifications.Engineering evaluation: one photo was provided.The reported component separation, was confirmed during evaluation of the provided device photo.Separation was observed between delivery catheter components, specifically between the distal shaft and transition attachment site at the dual lumen catheter.The provided image could not be used to further assess the component bonding sites, and the root cause of the distal shaft / transition detachment from the dual lumen catheter could not be established with the available information.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.

• 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: jorja nackard ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 21678264
• Report Number: 2017233-2025-05965
• Device Sequence Number: 18084758
• Product Code: NIP
• UDI-Device Identifier: 00733132622948
• UDI-Public: (01)00733132622948(17)270404
• Combination Product (Y/N): Y
• Initial Reporter State: OR
• 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
• Report Date (Section B): 03/24/2025

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: VBHR070502A
• 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: 03/03/2025
• Initial Report FDA Received Date: 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 64 KG