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

Catalog Number PAHR111002B

Device Problem Complete Blockage (1094)

Patient Problem Obstruction/Occlusion (2422)

Event Date 05/03/2023

Event Type  Injury  

Event Description

The following was reported to gore: on (b)(6) 2023, during an endovascular treatment of popliteal artery aneurysm, an 11 x 10 gore® viabahn® endoprosthesis with propaten bioactive surface (vsx device) was implanted.On or about on (b)(6) 2023 (about two weeks post implant), the patient stated he started experiencing claudication on incline, which persisted for two weeks.On (b)(6) 2023, the patient presented in the er with acute pain, numbness and a pale foot.Angiography showed distal thrombus embolism into the tibial arteries.On the same day, thrombectomy was performed and four additional vsx devices were implanted.The four additional vbx devices were used from the distal to proximal, to reline the previously implanted vsx device.The patient was then placed on lysis infusion for 48 hours post intervention.As reported, patient was taking apixaban pre-operatively due to dvt on (b)(6) 2022.The medication was continued post-operatively.

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.A4: patient weight was not available.H3 and h6 code c20: device remains implanted; therefore, direct product analysis was not possible.H6 - code c19: review of device manufacturing record history confirmed device met pre-release specifications.Instructions for use for gore® viabahn® endoprosthesis hazards and adverse events.Procedure related: as with all procedures that utilize techniques for introducing a catheter into a vessel, complications may be expected.These complications include, but are not limited to: access site infection; entry site bleeding and / or hematoma; vessel thrombosis, occlusion, pseudoaneurysm, and trauma to the vessel wall (including rupture or dissection); distal embolization; arteriovenous fistula formation; transient or permanent contrast induced renal failure; renal toxicity; sepsis; shock; radiation injury; myocardial infarction; fever; pain; malposition; malapposition; inflammation; and / or death.Device related: complications and adverse events can occur when using any endovascular device.These complications include, but are not limited to: hematoma; stenosis, thrombosis or occlusion; distal embolism; side branch occlusion; vessel wall trauma and / or rupture; false aneurysm; infection; inflammation; fever and / or pain in the absence of infection; deployment failure; migration; and device failure.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.

• 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: genevieve begay ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17099317
• MDR Text Key: 316943277
• Report Number: 2017233-2023-03994
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: AS
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PAHR111002B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/08/2021
• 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 Age: 62 YR
• Patient Sex: Male