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

Device Problems Off-Label Use (1494); Obstruction of Flow (2423)

Patient Problem Occlusion (1984)

Event Date 09/05/2017

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records could not be performed as device item/lot numbers were not available.Intended use / indications the gore® viabahn® endoprosthesis is indicated for improving blood flow in patients with symptomatic peripheral arterial disease in superficial femoral artery lesions with reference vessel diameters ranging from 4.0 ¿ 7.5 mm.The gore® viabahn® endoprosthesis is indicated for improving blood flow in patients with symptomatic peripheral arterial disease in iliac artery lesions with reference vessel diameters ranging from 4.0 ¿ 12 mm.Warnings ¿ w.L.Gore & associates has insufficient clinical and experimental data upon which to base any conclusions regarding the effectiveness of the gore® viabahn® endoprosthesis in applications other than the endovascular grafting of superficial femoral or iliac arteries.

Event Description

In a literature article titled "outcomes of chimney and/or periscope techniques in the endovascular management of complex aortic pathologies," it states 22 patients with complex aortic pathologies underwent endovascular treatment with various manufacturer devices, including gore® viabahn® endoprostheses.Twenty-two patients (17 males), ranging from 38 to 83 years with complex aortic pathologies were included in this retrospective study, from january 2013 to august 2016.Nineteen patients underwent only chimney and/or periscope techniques, while the other three underwent the chimney/periscope technique and received fenestrated/scallop stents at the same time.The complex aortic pathologies in this study refer to aortic pathologies that required repair and were accompanied by reconstructions of supra-aortic branches or visceral vessels.Twenty-six target vessels were fitted with forty chimney/periscope grafts (cpgs) and 17 gore® viabahn® endoprostheses were used.It was reported that one patient suffered an occlusion in the right renal stent in the fifth (5) month after his first procedure.This renal stent was returned to patency after the secondary procedure.The article stated seven (7) total stents were implanted in right renal artery: five bare metal stents and two cover stents.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8098239
• MDR Text Key: 128194171
• Report Number: 2017233-2018-00710
• 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
• Type of Report: Initial,Followup
• Report Date: 12/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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): Other
• Patient Age: 61 YR