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

Catalog Number JHJR061502J

Device Problem Obstruction of Flow (2423)

Patient Problems Occlusion (1984); Thrombosis (2100)

Event Date 10/26/2018

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records for the devices verified that the lots met all pre-release specifications.Per the gore® viabahn® endoprosthesis instructions for use, complications associated with the use of the gore® viabahn® endoprosthesis may include, but are not limited to thrombosis or occlusion.

Event Description

On (b)(6) 2018, the patient was implanted with two gore® viabahn® endoprostheses to treat chronic total occlusion (cto) of the left superficial femoral artery (sfa).After the endoprostheses were successfully implanted, blood flow was reportedly improved.The patient tolerated the procedure, and antiplatelet medications were administered.On (b)(6) 2018, the patient presented to the facility with left leg pain.A computed tomography scan reportedly revealed occlusion of both endoprostheses.The physician believed thrombosis to be the cause of the device occlusion.On (b)(6) 2018, an additional procedure was performed to treat the device occlusion.The left common femoral artery was surgically exposed, and a thrombectomy was performed with a fogarty catheter.Stenosis of both devices was still observed after the thrombectomy was performed; therefore, a pta balloon catheter was used to dilate the length of the devices.Blood flow in the devices was improved, but emboli were still reportedly observed in the deep femoral artery (dfa), the anterior tibial artery (ata) and the posterior tibial artery (pta).Thrombectomy was performed again and the blood flow to the dfa was increased, but the blood flow of the pta and the ata showed no reported improvement.The physician opted to treat the pta and the ata medically, and the procedure was completed.The patient tolerated the procedure.

Manufacturer Narrative

Please note correction to section b5: patient underwent treatment for chronic total occlusion of the right superficial femoral artery.All reported events occurred in the right limb.

Event Description

On (b)(6) 2018, the patient was implanted with two gore® viabahn® endoprostheses to treat chronic total occlusion (cto) of the right superficial femoral artery (sfa).After the endoprostheses were successfully implanted, blood flow was reportedly improved.The patient tolerated the procedure, and antiplatelet medications were administered.On (b)(6) 2018, the patient presented to the facility with right leg pain.A computed tomography scan reportedly revealed occlusion of both endoprostheses.The physician believed thrombosis to be the cause of the device occlusion.On (b)(6) 2018, an additional procedure was performed to treat the device occlusion.The right common femoral artery was surgically exposed, and a thrombectomy was performed with a fogarty catheter.Stenosis of both devices was still observed after the thrombectomy was performed; therefore, a pta balloon catheter was used to dilate the length of the devices.Blood flow in the devices was improved, but emboli were still reportedly observed in the deep femoral artery (dfa), the anterior tibial artery (ata) and the posterior tibial artery (pta).Thrombectomy was performed again and the blood flow to the dfa was increased, but the blood flow of the pta and the ata showed no reported improvement.The physician opted to treat the pta and the ata medically, and the procedure was completed.The patient tolerated the procedure.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8089000
• MDR Text Key: 127874776
• Report Number: 2017233-2018-00709
• 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: 11/27/2018

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: 03/17/2021
• Device Catalogue Number: JHJR061502J
• Device Lot Number: 18300198
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/20/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR