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

Catalog Number PAJR060202E

Device Problem Complete Blockage (1094)

Patient Problem Obstruction/Occlusion (2422)

Event Date 04/06/2023

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.H6 code b13: further information was requested from the site and were captured in the event description summary.H6 code b14: a review of the manufacturing records indicated the device met pre-release specifications.H3 and h6 code b20: the device remains implanted in the patient.Therefore a device evaluation could not be performed.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

Reportedly on (b)(6) 2023, this patient underwent a dialysis access revision for the treatment of an end stage renal disease.A gore® viabahn® endoprosthesis with propaten bioactive surface was used to create this revision in the right forearm.The whole procedure was performed without any complication.On (b)(6) 2023, an adverse event termed "rethrombosis of av fistula" was reported and the subject's participation in the study was discontinued on the same date.According to the most recent information, there was a stenotic lesion between both viabahn stents with thrombosis extending from the anastomosis to the cephalic vein in the arm, involving both stents.This was addressed in the reintervention but it thrombosed soon after.The patient was then considered for a tunneled cuffed catheter insertion for dialysis and another fistula later.

Manufacturer Narrative

H6 imdrf code update.

• 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: wilson okeke ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17171369
• MDR Text Key: 317629599
• Report Number: 2017233-2023-04046
• 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: Foreign,Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PAJR060202E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/24/2023
• Initial Date FDA Received: 06/21/2023
• Supplement Dates Manufacturer Received: 07/19/2023
• Supplement Dates FDA Received: 07/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Sex: Male