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

Catalog Number VBH130502W

Device Problem Positioning Problem (3009)

Patient Problem Perforation (2001)

Event Date 06/11/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4) - the item number and lot number of the device could not be provided, so no manufacturing evaluation could not be performed.(b)(4) -the device remains implanted.Therefore, direct product analysis was not possible.

Event Description

The following publication was reviewed: " a single center experience of in situ needle fenestration of supra-aortic branches during thoracic endovascular aortic repair" received through "ann vasc surg 2019; 61: 107¿115".The authors: yilang xiang, chenyang qiu, yangyan he, donglin li, tao shang, ziheng wu, and hongkun zhang.The article aimed to report the early results and technical details of in situ needle fenestration during thoracic endovascular aortic repair (tevar).Thirty-seven patients with thoracic aortic disease who underwent tevar with in situ needle fenestration in our department between february 2016 and april 2017 were included in this study.Their demographic information, clinical manifestations, periprocedural outcomes, and follow-up results were analyzed.Thus, the balloon was deployed, and viabahn stents (w.L.Gore associates, inc, flagstaff, az) were implanted.Given that expandable balloon-covered stents were unavailable in our center, we used self expanding viabahn stents and a mustang balloon (boston scientific, japan) for postdilation.Reported results stated in one case, the branch stent graft stuck in the brachial artery and was surgically removed.The physicians once advanced a stent graft through a short sheath.As a result, the stent graft became stuck in the patient¿s brachial artery, and an extended incision of the artery was performed to remove the stent graft.A long sheath was then reinserted to deliver the stent to the correct place.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 10458325
• MDR Text Key: 204524758
• Report Number: 2017233-2020-01184
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 01/06/2021

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: VBH130502W
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/11/2020
• Initial Date FDA Received: 08/27/2020
• Supplement Dates Manufacturer Received: 08/11/2020
• Supplement Dates FDA Received: 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR