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

Device Problem Complete Blockage (1094)

Patient Problem Occlusion (1984)

Event Date 02/17/2020

Event Type  Injury  

Manufacturer Narrative

A.K.Mirza, e.R.Tenorio, j.M.Kärkkäinen, j.Hofer, t.Macedo, s.Cha, et al.Learning curve of fenestrated and branched endovascular aortic repair for pararenal and thoracoabdominal aneurysms.J vasc surg (2020), 10.1016/j.Jvs.2019.09.046 [epub ahead of print].Patient demographics provided by the article: there were 334 consecutive patients, 255 males (76%) and 79 females (24%), with mean age of 75 +/- 7 years.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.The gore® viabahn® endoprosthesis instructions for use note occlusion as a potential device related adverse event.

Event Description

This information was received through literature article "learning curve of fenestrated and branched endovascular aortic repair for pararenal and thoracoabdominal aneurysms" published online in the journal of vascular surgery,17 february 2020.The objective of this study was to review the learning curve for fenestrated-branched endovascular aortic repair (f-bevar) of pararenal and thoracoabdominal aortic aneurysms (taaas).Data was reviewed for 334 consecutive patients who underwent f-bevar between 2007 and 2016 in a single institution.There were 178 patients (53%) treated for pararenal aneurysms and 156 (47%) for taaas.Alignment stents were used for all vessels incorporated by fenestrations or branches, selectively for single diameter scallops and were not recommended for double diameter scallops.Fenestrations were aligned by icast balloon-expandable covered stents, and directional branches were bridged to the target vessels using viabahn stent graft for the renal arteries or fluency stent graft for the celiac axis and superior mesenteric arteries.The article reports major adverse events.These events included stent graft occlusion.It is unknown if the reported occlusions and subsequent interventions were attributable to the gore® viabahn® endoprosthesis.

• 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: marci stewart ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 10497197
• MDR Text Key: 214800723
• Report Number: 2017233-2020-01228
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2020
• 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: 08/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR