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

Catalog Number PAJR071502E

Device Problem Complete Blockage (1094)

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

Event Date 06/03/2023

Event Type  Injury  

Manufacturer Narrative

C1: heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.H3 and h6 code b20: the device remains implanted in the patient.Therefore a device evaluation could not be performed.H6 code b14: a review of manufacturing records verified that the lot involved in this complaint met all pre-release specifications.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 Description

According to reports on (b)(6) 2023,, this patient underwent a surgical treatment for the creation of av access in the right upper arm with a gore® viabahn® endoprosthesis with propaten bioactive surface (vsx-device).During the procedure anticoagulant / antiplatelet was used and a post-dilation intra-stent performed.The vsx-device was successfully implanted and the study device was patent.There were no additional procedures performed at treatment.On (b)(6) 2023, the vsx-device thrombosed and a surgical reintervention including antiplatelet / anticoagulant medication was necessary and the event was resolved.

Manufacturer Narrative

A1: no patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.According to the gore® viabahn® endoprosthesis with propaten bioactive surface instructions for use (ifu) adverse events that may occur and / or require intervention or additional intraoperative procedure time include, but are not limited to: occlusion.Emdr section h6 codes updated to reflect results of investigation.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN 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: 17255969
• MDR Text Key: 318452191
• Report Number: 2017233-2023-04085
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: IT
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PAJR071502E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2021
• 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): Other
• Patient Age: 56 YR
• Patient Sex: Female