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

Device Problems Partial Blockage (1065); Complete Blockage (1094)

Patient Problems Stenosis (2263); Thrombosis/Thrombus (4440)

Event Date 03/01/2022

Event Type  Injury  

Event Description

Article reviewed: the evolving role of endovascular therapy in the management of arterial thoracic outlet syndrome.Authors - joe luis pantoja, md, david a.Rigberg, md, and hugh a.Gelabert, md.Journal of vascular surgery vol 75 no 3.This retrospective study describes the evolving role of endovascular management of arterial thoracic outlet syndrome (atos) over the past two decades and the expanded vascular surgeon role in the endovascular management of atos at a single institution.The group was divided into two time periods: p-1 with 27 cases covers january 1986 to august 2003 and period p-2 with 24 cases, between september 2003 and march 2021.Patients were grouped by type of subclavian artery reconstruction: endovascular reconstruction (stent graft repair) and open reconstruction (primary repair or bypass including aneurysm repair).Forty-eight patients with atos underwent transaxillary tos decompression.These 48 patients presented with 51 cases of atos (three patients had prohibitive bilateral disease) and nderwent 50 decompression operations (one patient had not yet undergone a decompression procedure at the time of the study).Covered self-expanding stents were utilized with a proximal landing zone distal to the vertebral artery.The first stent graft placed was a boston scientific wallgraft, and the rest were gore® viabahn® endoprosthesis with heparin bioactive surface.All eight stent grafts repairs were performed by vascular surgeons in p-2.At their respective follow-up time, the primary (63% vs 77%), primary assisted (75% vs 85%), and secondary patency rates (88% vs 92%) for endovascular repair were less than the open repair group.Overall secondary patency for the entire group was 91%.At the end of the average follow-up period of 4.3 years, less than one third of patients had residual symptoms, with 22% being ischemic or neurologic.Three were from group p2.Excluding the first endovascular case, which was done with an early stent graft no longer on the market, the subsequent cases have had durable results with one interval thrombosis and one interval stenosis that were both managed with endovascular methods.

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.Article reviewed: the evolving role of endovascular therapy in the management of arterial thoracic outlet syndrome.Authors - joe luis pantoja, md, david a.Rigberg, md, and hugh a.Gelabert, md.Journal of vascular surgery vol 75 no 3.(b)(4).Instructions for use for gore® viabahn® endoprosthesis with heparin bioactive surface state: warnings - w.L.Gore & associates has insufficient clinical and experimental data upon which to base any conclusions regarding the effectiveness of the gore® viabahn® endoprosthesis in applications other than the endovascular grafting of superficial femoral, iliac arteries or the venous anastomosis of the arteriovenous (av) access circuit.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
• Type of Device: 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: genevieve begay ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15220578
• MDR Text Key: 297859429
• Report Number: 2017233-2022-03208
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR
• Patient Sex: Female