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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation (2001)

Event Date 07/17/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The following publication was reviewed: "retrograde branched endovascular repair as a feasible option to treat complex aortic aneurysm using the retrograde branched extension limb assembling technique" received through "j vasc interv radiol 2019; 30:1956¿1963".The authors: yuan he, md, wei guo, md, jiang xiong, md, jie liu, md, et al.The article aimed to present the primary experiences in treating suprarenal aneurysms, juxtarenal aneurysms, thoracoabdominal aortic aneurysms, and aneurysms after dissection with hostile anatomical features using the retrograde branched extension limb assembling (rebel) technique.The study included 23 consecutive patients undergoing total endovascular repair with the rebel technique from august 2014 to january 2019.Twelve patients had abdominal aortic aneurysms (4 juxtarenal, 8 suprarenal), 6 had thoracoabdominal aortic aneurysms (type iv), and 5 had postdissection aneurysms.During the procedures, polytetrafluoroethylene-covered vascular prostheses or viabahn stents were chosen as the suspended bridge endografts.Reported results stated the second and third patients required reinvention at 12 and 18 months, respectively, because of a type ii endoleak from incomplete sealing of the distal sealing zone in the renal artery.These 2 patients were successfully treated with balloon-expandable covered stents.

• 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
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: pixie xi ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 10463804
• MDR Text Key: 204906822
• Report Number: 2017233-2020-01190
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/28/2020

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/12/2020
• Initial Date FDA Received: 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR