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

Catalog Number PAJR062502E

Device Problems Complete Blockage (1094); Device Stenosis (4066)

Patient Problems Ischemia (1942); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)

Event Date 05/30/2023

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.B13: follow up questions were sent to the physician and the answers have been reflected in the event description.B14: a review of manufacturing records verified that the lot involved in this complaint met all pre-release specifications.B20: the device remains implanted and was, therefore, not available for analysis.No clinical images enabling direct assessment of product performance were returned for evaluation.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

On (b)(6) 2023, the patient underwent an endovascular treatment of stenotic peripheral vascular diseases located in the left left superficial femoral artery using gore® viabahn® endoprosthesis with propaten bioactive surface (vsx).The treatment setting was an out-patient, vascular access was successfully gained through the right common femoral artery and the patient received an antiplatelet treatment.Reportedly the gore® viabahn® endoprosthesis with propaten bioactive surface (vsx) was successfully implanted and the delivery catheter successfully removed.On (b)(6) 2023, an adverse event termed "critical ischemia" was reported and further investigation revealed that the vsx device occluded, the primary relationship was indicated to be device related.A repeat intervention in the form of a thrombo-aspiration was performed and the patient recovered without a sequalae.

Manufacturer Narrative

Emdr section h6 codes updated to reflect results of investigation.Emdr section h6: code d12-he gore® viabahn® endoprosthesis with propaten bioactive surface instructions for use (ifu), for the appropriate region and time-period, was reviewed with respect to the complaint detail, and there are applicable statements.The ifu states the following: "possible adverse events and complications that may occur with the use of any gore® viabahn® endoprosthesis with propaten bioactive surface or in any endovascular procedure and require intervention include, but are not limited to: occlusion (thrombosis and/or stenosis) of endoprosthesis or vessel.".

• 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: 17956414
• MDR Text Key: 325907614
• Report Number: 2017233-2023-04343
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: FR
• PMA/PMN Number: P130006
• 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: 01/10/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: PAJR062502E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2023
• Initial Date FDA Received: 10/18/2023
• Supplement Dates Manufacturer Received: 06/29/2023
• Supplement Dates FDA Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2022
• 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: 71 YR
• Patient Sex: Male