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

Device Problems Leak/Splash (1354); Deformation Due to Compressive Stress (2889); Device Dislodged or Dislocated (2923); Patient Device Interaction Problem (4001)

Patient Problems Aneurysm (1708); Stenosis (2263); Obstruction/Occlusion (2422); Vascular Dissection (3160)

Event Date 03/29/2021

Event Type  Injury  

Manufacturer Narrative

Additional 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

Effect of celiac axis compression on target vessel related outcomes during fenestrated branch endovascular repair.Objective: to report the effect of median arcuate ligament (mal) compression on outcomes and technical aspects of celiac artery (ca) stenting during fenestrated-branched endovascular aneurysm repair for thoracoabdominal aortic aneurysms (taaa) or pararenal aortic aneurysms.Methods: we retrospectively reviewed the clinical and anatomic data on 300 consecutive patients enrolled in a prospective nonrandomized physician-sponsored investigational device exemption study from 2013 to 2018.From this group, 230 patients with ca incorporation by fenestration or directional branch were included.Mal compression was defined by preoperative computed tomography angiogram as a j-hook narrowing of the proximal ca at the level of the ligament; the shift angle between the downward and upward segments within the ca was measured.End points were technical success, rates of intraoperative or early (30-days) ca branch revision, and freedom from target vessel instability, defined by any death or rupture owing to target vessel complication, occlusion, or reintervention for stenosis, endoleak, or disconnection.Results: an intraoperative (n = 6, 2.6%) or early (n = 1, 0.4%) revision of the ca branch was required in seven patients (3%) owing to dissection/occlusion (n = 2 [0.9%]), kinking/stenosis (n = 3 [1.3%]), stent dislodgement (n = 1 [0.4%]), or type ic endoleak (n = 1 [0.4%]).The article notes: endoleak gore® viabahn® vbx balloon expandable endoprostheses devices implanted.

Manufacturer Narrative

Added - h6 health effect - clinical code, health effect - impact code, medical device problem code, and component code.Added article attachment.

• 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: 11729208
• MDR Text Key: 247498286
• Report Number: 2017233-2021-01905
• 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
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2021
• 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: 01/04/2022
• 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