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

Catalog Number VBJR050502A

Device Problems Leak/Splash (1354); Patient Device Interaction Problem (4001)

Patient Problems Aneurysm (1708); Hemorrhage/Bleeding (1888)

Event Date 03/08/2021

Event Type  Injury  

Manufacturer Narrative

Cbas® heparin surface incorporates cbas-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 reported to gore: in an article titled "outcomes of endovascular repair of chronic post dissection compared with degenerative thoracoabdominal aortic aneurysms using fenestrated-branched stent grafts".Objective: the objective of this study was to analyze outcomes of fenestrated-branched endovascular aneurysm repair (f/bevar) for treatment of postdissection and degenerative thoracoabdominal aortic aneurysms (taaas).Methods: we reviewed the clinical data of 240 patients with extent i to extent iii taaas enrolled in seven prospective physician-sponsored investigational device exemption studies from 2014 to 2017.All patients had manufactured off-the-shelf or patient-specific fenestrated-branched stent grafts used to target 888 renal-mesenteric arteries with a mean of 3.7 vessels per patient.The article notes: type ic and iiic endoleaks that occurred which could potentially be associated with the gore® viabahn® endoprosthesis with heparin bioactive surface devices implanted.

Manufacturer Narrative

Added a1 (3551).

• 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: marcos ayala ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11625293
• MDR Text Key: 244163751
• Report Number: 2017233-2021-01847
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/29/2021

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: VBJR050502A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2021
• Initial Date FDA Received: 04/06/2021
• Supplement Dates Manufacturer Received: 03/17/2021; 03/17/2021
• Supplement Dates FDA Received: 12/29/2021; 12/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male