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

Device Problem Insufficient Information (3190)

Patient Problem Stenosis (2263)

Event Date 01/11/2020

Event Type  Injury  

Manufacturer Narrative

Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

Event Description

The following information was received through literature ¿mid-term results of in situ fenestration stented with balloon-expandable bare metal stents during thoracic endovascular aortic repair¿ published by catheter cardiovasc interv.2020; 95:1163¿1168.The study was to assess the safety, feasibility and effectiveness of balloon-expandable bare metal stents (bms) as bridge stents during thoracic endovascular aortic repair (tevar).The results state in the series, one case with an 8*50 mm viabahn®-covered stent had a 50% residual stenosis in the connecting part of aortic graft and bridging stent after pre-dilation.The stenosis was not resolved after several dilations, but it was resolved after another 8*37-mm balloon-expandable bare stent was inserted.

Manufacturer Narrative

Remove c1.H6: 213-due to an unknown lot/serial number and no device return, an investigation could not be performed.Citation: jun bai, yandong liu, jie jin, jianjin wu.Mid-term results of in situ fenestration stented with balloon-expandable bare metal stents during thoracic endovascular aortic repair.Catheter cardiovasc interv.2020; 95:1163¿1168.Doi: 10.1002/ccd.28743.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS
• 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: 14882109
• MDR Text Key: 295116336
• Report Number: 2017233-2022-03086
• 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: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2022
• 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
• Date Manufacturer Received: 07/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male