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

Catalog Number JHJR061502J

Device Problems Complete Blockage (1094); Device-Device Incompatibility (2919)

Patient Problems Occlusion (1984); Thrombosis (2100)

Event Date 01/22/2019

Event Type  Injury  

Event Description

The following information was reported to gore: on (b)(6) 2018, a patient underwent treatment of a total stenotic occlusion of the right superficial femoral artery with a gore® viabahn® endoprosthesis with heparin bioactive surface proximally and a zilver ptx stent distally.On (b)(6) 2019, a device occlusion of gore® viabahn® endoprosthesis with heparin bioactive surface was reported to gore.The occlusion was observed from just below the sfa bifurcation to the popliteal artery.On (b)(6) 2019, the patient underwent thrombectomy using a fogarty catheter from just below a sfa bifurcation to the origin of the popliteal artery to treat the occlusion.Thrombus was confirmed in the previously implanted stents and progression was noted distal to the implanted stents.During the thrombectomy, the thrombectomy catheter became stuck on the stent, and the stent became bent.To correct the stent bending and to press the thrombus to the vessel wall, an additional viabahn was implanted inside the stent.The patient tolerated the procedure.

Manufacturer Narrative

Implant date corrected.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8347700
• MDR Text Key: 136497138
• Report Number: 2017233-2019-00085
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: JHJR061502J
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 71 YR