MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS; ILIAC COVERED STENT, ARTERIAL

Catalog Number BXA085901J

Device Problems Obstruction of Flow (2423); Patient Device Interaction Problem (4001)

Patient Problems Stenosis (2263); Obstruction/Occlusion (2422)

Event Date 03/17/2021

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 post-dissection 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: occlusion and stenosis that occurred which could potentially be associated with the gore® viabahn® vbx balloon expandable endoprosthesis devices implanted.

Manufacturer Narrative

Added a1 added a3 added h6.

Manufacturer Narrative

Added a1 (b)(6).

• Brand Name: GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Type of Device: ILIAC COVERED STENT, ARTERIAL
• 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: 11625183
• MDR Text Key: 244162590
• Report Number: 2017233-2021-01846
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P160021
• 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

• Date FDA Received: 04/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: BXA085901J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2021
• 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