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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 11/12/2021

Event Type  Injury  

Manufacturer Narrative

Article citation: title: comparison of popliteal artery aneurysm outcomes after open repair and endovascular repair: reducing post-operative type ii endoleak and sac enlargement.Author: ge j, wang t, zhao j, yuan d, huang b, yang y.Doi: 10.21037/atm-21-5631 ann transl med 2021;9(22):1688.Patient demographics: provided mean age was 63.6 years old and gender of article is 91% male, 9% female.Patient information will reflect 64-year-old male.Patient weight was unavailable.Implant date was unavailable.A review of the manufacturing records for the device was unable to be conducted as no lot number was available.The device was not accessible for testing, and information was not made available, therefore, the device was not able to be evaluated.It is unknown if these adverse events were related to the viabahn devices.Information was not made available.Cause of the event cannot be established based on the available information.Further information regarding this event was requested by gore, but no further information has been reported, therefore this investigation is considered complete.Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.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

The following information was received through literature ¿comparison of popliteal artery aneurysm outcomes after open repair and endovascular repair: reducing post-operative type ii endoleak and sac enlargement¿ published in annals of translational medicine in 2021.The study aimed to evaluate the short- and long-term outcomes of open repair (or) and endovascular repair (er) to treat popliteal artery aneurysm for 181 patients.From january 2000 to august 2020, 151 or patients were treated with autologous-vein (n=100) and vascular graft (n=51), 35 er patients were treated with viabahn® devices.Peri-operative complications included, 1 er patient had acute thrombosis, underwent emergency embolectomy.1 er patient had pseudoaneurysm, was performed with emergency procedure to excise the pseudoaneurysm.

• 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: qiong wang ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15143278
• MDR Text Key: 297032748
• Report Number: 2017233-2022-03178
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/09/2022
• 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: 64 YR
• Patient Sex: Male