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

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 11/27/2020

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 article was reviewed by gore: "renal stent complications and impact on renal function after standard fenestrated endovascular aneurysm repair." authors: celine deslarzes-dubuis, kenneth tran, benjamin d.Colvard, jason t.Lee, annals of vascular surgery, volume 72, 2021, pages 106-113.A 60 total of gore® viabahn® vbx balloon expandable endoprosthesis (vbx) and 133 icast devices were utilized as bridging stents.17 total renal stent-related complications were reported including stent occlusions (n=4), stenosis (n=9), dislocation (n=3), and endoleak (n=1).All stent complications underwent reintervention with a technical success of 94.2%.Patients with occlusion were treated the day of diagnosis with a mean time from diagnosis to reintervention of 21.5 days.The study concludes with stating that: "fevar is a durable option for the treatment of juxtarenal aortic aneurysms and is associated with excellent secondary patency.Renal stent complications have no significant impact on renal function, but smaller native renal arteries are at higher risk of stent-graft complications." this report is covering the allegations of migration (3) with reported reintervention in the renal arteries of multiple patients (none of which have specifically identified a vbx device as the medical device associated with the allegation).Further information has been requested but has not been made available at this time.

Manufacturer Narrative

Updated to include the following additional information: patient information a2 and a3 fields.

• 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: 11721008
• MDR Text Key: 249102151
• Report Number: 2017233-2021-01897
• 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: company representative,litera
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/26/2021
• Initial Date FDA Received: 04/23/2021
• Supplement Dates Manufacturer Received: 03/26/2021; 03/26/2021
• Supplement Dates FDA Received: 07/21/2021; 10/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR