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

Catalog Number PAJR072502E

Device Problem Complete Blockage (1094)

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

Event Date 09/14/2022

Event Type  Injury  

Manufacturer Narrative

No patient specific details have been provided.Therefore, the patient initials reflect the study number with codes for the hospital and patient.As the device remains implanted, no further investigation can be performed.A review of the manufacturing-, heparin-coating- and sterilization records indicated the lot met all pre-release specifications.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 was reported to gore: on (b)(6) 2022, the patient underwent endovascular treatment for de novo or restenotic lesions in the right superficial femoral artery (sfa) and proximal popliteal artery as verified by imaging with a gore® viabahn® endoprosthesis with propaten bioactive surface (vsx-device).In addition, the patient had a popliteal aneurysm in the target vessel.During the procedure an anticoagulant or antiplatelet was used and prior- and post dilation performed.A vsx-device was implanted successfully with a boston eluvia vascular implant, and at the end of the procedure the right study device was patent.The patient required non vsx-devices placed in the target vessel during the same procedure.There were no additional procedures performed at treatment.The patient was discharged home the next day.On (b)(6) 2022, right sfa intrastent thrombosis occurred.Treatment was required for this adverse event which includes antiplatelet / anticoagulant medication.No repeat intervention on the study limb was needed, as there was repermeabilisation from the supra-articular segment of the popliteal artery through collateralisation and improvement in symptomatology after introduction of curative intravenous heparin anticoagulation.Therefore, the team decided to leave the patient to medical treatment.The patient was still in pain at discharge so the event is still ongoing at the last news.

Manufacturer Narrative

As the device remains implanted, no further investigation can be performed.No clinical images enabling direct assessment of product performance were returned for investigation.The physician stated that the thrombosis in the right sfa was caused by calcification.There was a recoil after vsx-device and boston eluvia device treatment caused by calcium.The endovascular reintervention solved the issue and the vsx-device was patent at the end of the procedure.In the instruction for use for the gore® viabahn® endoprosthesis with propaten bioactive surface the following is stated: 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: vessel thrombosis, occlusion.Device related: complications and adverse events can occur when using any endovascular device.These complications include, but are not limited to: thrombosis or occlusion.

Event Description

The following was reported to gore: on (b)(6) 2022, the patient underwent endovascular treatment for de novo or restenotic lesions in the right superficial femoral artery (sfa) and proximal popliteal artery as verified by imaging with a gore® viabahn® endoprosthesis with propaten bioactive surface (vsx-device).In addition, the patient had a popliteal aneurysm in the target vessel.During the procedure an anticoagulant or antiplatelet was used and prior- and post dilation performed.A vsx-device was implanted successfully with a boston eluvia vascular implant, and at the end of the procedure the right study device was patent.The patient required non vsx-devices placed in the target vessel during the same procedure.There were no additional procedures performed at treatment.The patient was discharged home the next day.On (b)(6) 2022, right sfa intrastent thrombosis occurred.Treatment was required for this adverse event which includes antiplatelet / anticoagulant medication.No repeat intervention on the study limb was needed, as there was repermeabilisation from the supra-articular segment of the popliteal artery through collateralisation and improvement in symptomatology after introduction of curative intravenous heparin anticoagulation.Therefore, the team decided to leave the patient to medical treatment.The patient was still in pain at discharge.On (b)(6) 2022, an endovascular reintervention within the study device was performed for the total vessel occlusion including use of anticoagulant or antiplatelet.There were no procedural complications.The vsx-device patency was restored / maintained at the end of the procedure.The physician stated that the thrombosis in the right sfa was caused by calcification.There was a recoil after vsx-device and boston eluvia device treatment caused by calcium.The endovascular reintervention solved the issue.

• 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: gunter marte ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15697918
• MDR Text Key: 302690456
• Report Number: 2017233-2022-03436
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: FR
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/09/2023

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: PAJR072502E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2022
• Initial Date FDA Received: 10/31/2022
• Supplement Dates Manufacturer Received: 12/16/2022
• Supplement Dates FDA Received: 01/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2022
• 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
• Treatment: BOSTON ELUVIA VASCULAR IMPLANT
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Sex: Male