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

Catalog Number PAJR051002E

Device Problems Complete Blockage (1094); Insufficient Information (3190); Device Stenosis (4066)

Patient Problems Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)

Event Date 07/20/2023

Event Type  Injury  

Event Description

Reportedly, on (b)(6) 2023, this patient underwent an endovascular treatment for an occlusive peripheral vascular disease (pad) in the right proximal superficial femoral artery that was treated with three gore® viabahn® endoprostheses with propaten bioactive surface (viabahn® devices).Vascular access was gained through the left common femoral artery.The viabahn® devices were successfully navigated and deployed in the intended location.Post-dilation was performed along the viabahn® devices.The delivery catheters were successfully removed and patency of the viabahn® devices was confirmed at the end of the procedure.According to study database entries, on (b)(6) 2023, a total vessel occlusion of the viabahn® devices of the stented femoral-popliteal segment has been reported.The patient therefore underwent an endovascular reintervention including a mechanical thrombectomy followed by a day of thrombolysis.Reportedly a blood transfusion was required.No procedural consequences were reported, the vsx devices patency has been restored at the end of the procedure.The patient was discharged home on (b)(6) 2023.

Manufacturer Narrative

C1: cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.H3: code "other" was selected as the medical device remains implanted.Return not possible.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.

Manufacturer Narrative

H6: updated for final coding.Code d12 used for: in the instructions for use for the gore® viabahn® endoprosthesis with propaten bioactive surface the following is stated: adverse events possible adverse events and complications that may occur with the use of any gore® viabahn® endoprosthesis with propaten bioactive surface or in any endovascular procedure and require intervention include, but are not limited to (shown in alphabetical order): occlusion (thrombosis and/or stenosis) of endoprosthesis or vessel.

Event Description

Reportedly, on (b)(6) 2023, this patient underwent an endovascular treatment for an occlusive peripheral vascular disease (pad) in the right proximal superficial femoral artery that was treated with three gore® viabahn® endoprostheses with propaten bioactive surface (viabahn® devices).Vascular access was gained through the left common femoral artery.The viabahn® devices were successfully navigated and deployed in the intended location.Post-dilation was performed along the viabahn® devices.The delivery catheters were successfully removed and patency of the viabahn® devices was confirmed at the end of the procedure.According to study database entries, on (b)(6) 2023, a total vessel occlusion of the viabahn® devices of the stented femoral-popliteal segment has been reported.The patient therefore underwent an endovascular reintervention including a mechanical thrombectomy followed by a day of thrombolysis.During the procedure the patient lost 500 ml of blood requiring three blood transfusions.No procedural consequences were reported, the vsx devices patency has been restored at the end of the procedure.The patient was discharged home on (b)(6) 2023.

• 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: samir kulovic ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18010752
• MDR Text Key: 326606832
• Report Number: 2017233-2023-04357
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: SW
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PAJR051002E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2023
• 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: 72 YR
• Patient Sex: Female