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

Catalog Number BXA075901J

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Occlusion (1984)

Event Date 10/08/2020

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 was reported to gore: on (b)(6) 2020, the patient underwent endovascular procedure to treat aorto-bilateral common iliac artery occlusion using two gore® viabahn® vbx balloon expandable endoprostheses with kissing stent technique.The procedure was completed with no reported issue.On (b)(6) 2020, there was no pulsation around popliteal area, and angiography was performed.Slow flow of the right gore® viabahn® vbx balloon expandable endoprosthesis and little flow of the left gore® viabahn® vbx balloon expandable endoprosthesis were confirmed.Computed tomography angiography showed that the both ends of the devices were expanded, but the center area of the devices was flattened.On (b)(6) 2020, re-intervention to reinforce the right gore® viabahn® vbx balloon expandable endoprosthesis was performed.Intraprocedural angiography confirmed that the endoprosthesis had stenosis but there was blood flow.Two non-gore stents were additionally implanted in the right gore® viabahn® vbx balloon expandable endoprosthesis, and the procedure was completed.The patient tolerated the procedure.Reportedly, femoral-femoral bypass procedure is also planned.The physician reported that the patient was slightly-built and had rounded back, and the body shape might have contributed to the event.Another physician who also attended to the reintervention reported that it was also possible that the device was pushed by aortic blood flow because kissing stent technique was used in the aorta and therefore there was a gap between the vessel wall and the devices.

Manufacturer Narrative

Corrected h6 conclusion code.Engineering evaluation: the referenced complaint did not have a returned device.The following evaluation is based on information obtained from the event description and communication summary.Crush resistance of the vbx device can be influenced by the stent ring material, stent ring geometry, stent ring spacing, and stent ring alignment.The stent rings are certified by the supplier for the material and geometric properties.Stent rings are 100% verified during the manufacturing process to be free of visual deformities.Stent ring geometry, spacing, and alignment are 100% verified during the manufacturing process.The device history file was reviewed, and no anomalies were identified.Machine history files were reviewed, and no non-routine maintenance was identified.Based on the device evaluation performed, no manufacturing anomalies were identified to which the event could be definitively attributed.

• 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
• MDR Report Key: 10748597
• MDR Text Key: 213467061
• Report Number: 2017233-2020-01386
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: BXA075901J
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/27/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention