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

Catalog Number PAHR091502E

Device Problem Complete Blockage (1094)

Patient Problems Ischemia (1942); Thrombosis/Thrombus (4440)

Event Date 06/29/2023

Event Type  Injury  

Manufacturer Narrative

H6-b15: a study alert was received from a medical database.The electronic customer remarks form was reviewed.The provided information is captured in sections a through e.H6-b20 and h3-other: the device remains implanted in the patient.Therefore a device evaluation could not be performed.H6-b14: the manufacturing records are being reviewed.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

It was reported to gore that the patient underwent endovascular treatment on (b)(6) 2023, for a popliteal artery aneurysm in the right limb, which diameter is greater than 2 cm and which contains mural thrombus, as verified by imaging, with a gore® viabahn® endoprosthesis with propaten bioactive surface (vsx-device).Percutaneous access was done over the right common femoral artery.During the procedure anticoagulant / antiplatelet was used and post-dilation was performed.The vsx-device was successfully implanted, and the study device was patent.As additional procedure a percutaneous transluminal angioplasty (pta) of the anterior tibial artery and the posterior tibial artery was performed.On (b)(6) 2023, an acute limb ischemia occurred on the right study limb, which required treatment and a repeat intervention on the study limb, including antiplatelet / anticoagulant medication.The same day a surgical reintervention within the study device was performed due to total vessel occlusion.The study device was bypassed and there were no procedural complications.

Manufacturer Narrative

H6 evaluation codes investigation findings c19 refers to the product history review: a review of the manufacturing, sterilization and heparin coating records indicated the lots met all pre-release specifications.Neither images enabling direct assessment of product performance nor the product itself were returned for evaluation.In the instruction for use for the gore® viabahn® endoprosthesis with propaten bioactive surface the following is stated: adverse events 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: sibylle staerk ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17493973
• MDR Text Key: 320768118
• Report Number: 2017233-2023-04188
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: IT
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PAHR091502E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2023
• 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): Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 120 KG