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

Catalog Number BXA065902F

Device Problem Complete Blockage (1094)

Patient Problem Occlusion (1984)

Event Date 10/06/2019

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.(b)(4): a review of the manufacturing records for the devices verified the lots met all pre-release specifications.Concomitant medical devices.The second device utilized in the left renal was bxa065902f, serial number (b)(4), udi: (b)(4).As it is not known if one or both of the devices were occluded, both were investigated.Th right renal artery occlusion is being investigated under (b)(4).Report # 2017233-2020-01157.

Event Description

On (b)(6) 2014, this patient underwent endovascular treatment for an aortic aneurysm of unknown maximum diameter and involved visceral branch vessels.The patient is enrolled in the aaa 13-02 tambe ide study.It was reported that the procedure included implant of gore® viabahn® vbx balloon expandable endoprostheses in the renal arteries.On (b)(6) 2019 both renal arteries were occluded.On (b)(6) 2019 a thrombectomy was performed on each side and the right renal artery stents were relined with a non-gore bare metal stent.This report covers the left renal artery occlusion.

• 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: 10451460
• MDR Text Key: 204342902
• Report Number: 2017233-2020-01161
• 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
• Source Type: study
• Type of Report: Initial,Followup
• Report Date: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/17/2016
• Device Catalogue Number: BXA065902F
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Weight: 63