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

Device Problem Device Stenosis (4066)

Patient Problem Obstruction/Occlusion (2422)

Event Date 10/01/2023

Event Type  Injury  

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.Information was obtained through a publication.Author was unable to provide any further details to aid in further investigation.No lot number information was supplied; therefore, no review of the manufacturing records could be reviewed.The device(s) were not returned and no images were provided.Therefore, direct product analysis was not possible.The gore® viabahn® endoprosthesis with heparin bioactive surface instruction for use (ifu), section hazards and adverse events states, complications and adverse events can occur when using any endovascular device.These complications include, but are not limited to: thrombosis or occlusion.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

Yosuke yamamoto, et al.The early outcomes of the endovascular treatment for arterial vascular injury after hepato-biliary-pancreatic surgery.The journal of japanese college of angiology 2023: 63(suppl.) p.S189-190.Patients who underwent endovascular procedure using gore® viabahn® endoprosthesis (viabahn) for arterial vascular injury after hepato-biliary-pancreatic surgery were reviewed.21 arteries of 20 patients (16 male / 4 female) treated with viabahn at single institution from january 2017 to october 2022 were subject to evaluation.The average age of the patients was 67.5 (50-77).Technical success and clinical success rates were 95.2% and 100% respectively.In 1 case, stent graft patency could not be evaluated due to the coil metal artifact.As a result, contrast enhanced ct images of 18 arteries/17 patients were evaluated over time.The average follow-up period was 513.2 days (7-2020 days).In 3 cases, loss of stent graft patency was confirmed.The median stent patency was 1020 days.The patency rate at 1, 2, and 3 years was 83.3%, 83.3% and 62.5% respectively.

• 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: jorja nackard ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18627356
• MDR Text Key: 334356243
• Report Number: 2017233-2024-04586
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: JA
• 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,Followup
• Report Date: 02/23/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2024
• Initial Date FDA Received: 02/01/2024
• Supplement Dates Manufacturer Received: 01/12/2024
• Supplement Dates FDA Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 68 YR