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

Device Problems Obstruction of Flow (2423); Insufficient Information (3190)

Patient Problems Obstruction/Occlusion (2422); Vascular Dissection (3160)

Event Date 07/31/2021

Event Type  Injury  

Event Description

The following publication was reviewed: clinical outcomes of endovascular procedure using viabahn® vbx covered stent in complex aortoiliac artery disease: result from avocado study.Objective: to investigate the safety and efficacy of a balloon-expandable covered stent in the treatment of complex aortoiliac artery disease.Background: peripheral intervention in complex aortoiliac disease still remains a challenge.Methods: we retrospectively analyzed symptomatic patients with aortoiliac disease who were treated with gore® viabahn® vbx covered stent (w.L.Gore & associates (b)(4)).The primary study outcome was a 1-year primary patency without the necessity of any subsequent clinically-driven target revascularization (cd-tlr) based intervention.The proportion of technical success, defined in terms of the absence of residual stenosis, stent edge dissection, and procedure-related severe complications, was also reported.Results: vbx covered stent was used in 231 patients.Key patient characteristics include mean age of 73.4 ± 9 years, 77% male, 45% diabetes, and 18% suffering from end-stage renal dysfunction on dialysis.Tasc ii cd lesions were observed in 51% patients, which included 81% calcified lesions.Combined therapy with standard self expandable stent was performed in 40% patients.The technical success rate was 92.6%.Stent edge dissection was reported in seven cases (2.6%) with iliac lesion.Out of those seven cases, five cases required additional stent implantation, whereas 2 cases were kept under observation only till their condition stabilized.Distal embolism occurred in five cases (2.2%).One case needed surgical repair, whereas three cases underwent catheter thrombectomy.Access site complication was reported in 4 cases (1.7%).During median follow-up after 13.1 months, the primary patency rate was estimated to be 93.4% (95% confidence interval, 90.0%¿96.8%) at 12 months, whereas the rate of freedom from tlr was 95.3% (92.5%¿98.2%).As per the univariate analysis, the tasc ii classification, number of diseased regions, and chronic total occlusion were significantly associated with risk of restenosis.Conclusions: the results of the year-long avocado study demonstrated that usage of the novel vbx covered stent has a patency-based advantage with reduced chances for subsequent revascularization procedures.

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.Due to an unknown lot/serial number and no device return, an investigation could not be performed.

Manufacturer Narrative

Attached literature article.

• 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: spencer deboard ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14106899
• MDR Text Key: 290539820
• Report Number: 2017233-2022-02863
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2022
• 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: 03/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention