MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN® ENDOPROSTHESIS - 3; NIP

Catalog Number JHJR051502J

Device Problem Partial Blockage (1065)

Patient Problems Occlusion (1984); Claudication (2550)

Event Date 02/15/2019

Event Type  Injury  

Manufacturer Narrative

The review of the manufacturing paperwork verified that the lot met all pre-release specifications.According to the gore® viabahn® endoprosthesis with heparin bioactive surface instructions for use (ifu), complications and adverse events can occur when using any endovascular device.These complications include, but are not limited to thrombosis or occlusion.

Event Description

On (b)(6) 2019, the patient underwent an endovascular repair for a stenosis or occlusion of the left superficial femoral artery using a gore® viabahn® endoprosthesis with heparin bioactive surface and a bare metal stent.The stent was implanted proximally of the gore® viabahn® endoprosthesis.On (b)(6) 2019, the patient complained claudication symptom.It was confirmed the thrombotic occlusion of the endoprosthesis from the overlap site between the stent and the endoprosthesis.On (b)(6) 2019, a thrombectomy was performed to treat the thrombotic occlusion.After that, the endoprosthesis and a part of the stent (approximately 1cm of distal end of the stent) was relined with a gore viabahn endoprosthesis.The patient tolerated the procedure.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: nataliya baramzina ; 1500 n. 4th street; 9285263030
• MDR Report Key: 8434969
• MDR Text Key: 139292920
• Report Number: 2017233-2019-00155
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/27/2019

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 Expiration Date: 01/10/2021
• Device Catalogue Number: JHJR051502J
• Device Lot Number: 17819103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2018
• 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: 82 YR